Engages Thrive Health, a Leading Digital Patient Care Platform to Streamline Care Programs and Data Collection
NeonMind Biosciences Inc. (CSE:NEON)(OTCQB:NMDBD)(FRA:6UF) ("NeonMind'' or the "Company"), announced today it has advanced its strategy to streamline access to treatments at its specialty mental health clinics with Thrive Health in preparation of opening its inaugural clinic located in Mississauga, Ontario
The recent inclusion of intravenous ketamine for mood and anxiety disorders (IV-Ket) in the Canadian guidelines as a recommended treatment is a testament to the value of this treatment, and a growing number of institutions are providing coverage for IV-Ket treatment, setting the precedent for further coverage. Using Thrive Health's robust care management platform to collect patient profiles, manage care programs, and measure treatment outcomes allows us to improve payment coverage for our treatments and better serve our patients.
"We are seeing greater institutional coverage for IV-Ket treatment which is a testament to the treatment's value to the health system," said Rob Tessarolo, President & CEO of NeonMind. "Institutional reimbursement validates the treatment in Canada, and we are primed for increased demand for this treatment".
Rob Tessarolo also added, "NeonMind is focused on improving treatment outcomes and being able to collect and analyze treatment data throughout our network of clinics will provide a more robust value story for adoption of our treatments and establishing payment coverage for our patients. Working with leading digital healthcare platforms such as Thrive Health enables us to deploy our strategies with scale."
NeonMind will be working with Thrive Health, a trusted digital care platform used by many hospitals and clinics and selected as the official partner by Health Canada in the development of the Canada COVID-19 app.
NeonMind's inaugural specialty mental health clinic is located at 89 Queensway West, Suite 604, Mississauga, Ontario, L5B 2V2. For more information related to NeonMind's specialty clinics, please email medicalinformation@neonmind.com.
About Thrive Health Inc.
Thrive Health was founded in 2016 by a diverse group of patients, clinicians, researchers, parents, and students who came together to help patients going through complex health journeys, working to put people at the center of their care. Thrive's platform powers health, wellness and care solutions for organizations by empowering individuals with compelling digital experiences. Thrive operates across North America, headquartered in Vancouver BC, and is on a mission to make healthcare work better for everyone.
For more information about Thrive Health, visit https://welcome.thrive.health/
About NeonMind Biosciences Inc.
NeonMind operates two divisions: (i) a pharmaceutical division engaged in drug development of psychedelic compounds with two lead psilocybin-based drug candidates targeting obesity; and (ii) a medical services division focused on launching specialty mental health clinics that integrate psychedelic therapeutics into traditional psychotherapy settings.
In its pharmaceutical division, NeonMind has two distinct psilocybin drug development programs targeting obesity. NeonMind's lead candidate, NEO-001, employs psilocybin as an agonist at the serotonin 5- HT2A receptor, which is involved in the hallucinogenic effect of psychedelics. The Company's second drug candidate, NEO-002, employs low-dose psilocybin as an agonist at the 5-HT2C receptor, which controls appetite.
NeonMind and its strategic partners are building NeonMind-branded specialty mental health clinics in Canada that incorporate evidence-backed innovative treatments to address a variety of mental health needs. For more information on NeonMind, visit www.NeonMindBiosciences.com.
CONTACT:
Rob Tessarolo, President & Chief Executive Officer, NeonMind Biosciences Inc.
rob@neonmind.com
Tel: 416-750-3101
The Canadian Securities Exchange has not reviewed, approved nor disapproved the contents of this news release.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or NeonMind's future performance. The use of any of the words "could", "expect", "believe", "will", "projected", "estimated" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on NeonMind's current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, NeonMind's drug development plans, its ability to retain key personnel, and its expectation as to the development of its intellectual property and other steps in its preclinical and clinical drug development constitute forward-looking information. Actual results and developments may differ materially from those contemplated by forward-looking information. Readers are cautioned not to place undue reliance on forward-looking information. The statements made in this press release are made as of the date hereof. NeonMind disclaims any intention or obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as may be expressly required by applicable securities laws.
SOURCE: NeonMind Biosciences Inc.
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Initiates Medical Adoption Program with Impetus Digital, a Leading Healthcare Platform for Virtual Medical Education
NeonMind Biosciences Inc. (CSE:NEON)(OTCQB:NMDBD)(FRA:6UF) ("NeonMind'' or the "Company"), an integrated drug development and wellness company focused on bringing innovative psychedelic-based treatments to people suffering from obesity and mental health disorders, announced today it has advanced its strategy to enhance access to treatments at its specialty mental health clinics with Impetus Digital in preparation of opening its inaugural clinic located in Mississauga, Ontario
Intravenous ketamine for mood and anxiety disorders (IV-Ket) was recently included in the Canadian guidelines as a recommended treatment. As a testament to the value of IV-Ket treatments, a growing number of prescribers and their patients are seeking access to this treatment with further opportunities to expand the prescriber base through medical education.
"This is an exciting time for this ground-breaking treatment in Canada as success in adopting novel treatments is vastly enhanced by strong clinical evidence," said Rob Tessarolo, President & CEO of NeonMind. "Guideline inclusion means that Canadian medical leadership has reviewed the evidence and recommend the use of IV-Ket for treatment".
Rob Tessarolo also added "NeonMind is now focused on improving availability of access points for IV-Ket treatments with its setup of a network of clinic locations throughout Canada in partnership with leading specialty treatment companies with hundreds of clinic locations already established. We are also focusing on improving education and adoption of our treatments using proven commercial strategies. Working with a leading digital platform provider such as Impetus Digital will help disseminate medical education and enhance adoption of this important treatment".
NeonMind will be working with Impetus Digital's InSite Platform®, a trusted platform for virtual medical education to enhance adoption of IV-Ket treatments. This platform will enable us to establish prescriber confidence to include IV-Ket in their treatment toolset and how to refer patients to NeonMind clinics. Impetus Digital has been integral in successful pharmaceutical and healthcare treatment launches in Canada.
NeonMind's inaugural specialty mental health clinic is located at 89 Queensway West, Suite 604, Mississauga, Ontario, L5B 2V2. For more information related to NeonMind's specialty clinics, please email medicalinformation@neonmind.com.
About Impetus Digital
Headquartered in Toronto, Ontario, Impetus Digital helps life science organizations across the globe virtualize their in-person meetings, events, and programs, including medical education and product launches. They do this through their best-in-class InSite Touchpoints™ and InSite Events™ offerings, delivered with White-Glove™ service and 360° coverage and care. Leveraging their large portfolio of cutting-edge, life science-specific online collaboration tools, clients can seamlessly gather insights from, and collaborate with, internal and external stakeholders. To find out more about Impetus Digital, visit www.impetusdigital.com or book a demo at www.meetwithimpetus.com
About NeonMind Biosciences Inc.
NeonMind operates two divisions: (i) a pharmaceutical division engaged in drug development of psychedelic compounds with two lead psilocybin-based drug candidates targeting obesity; and (ii) a medical services division focused on launching specialty mental health clinics that integrate psychedelic therapeutics into traditional psychotherapy settings.
In its pharmaceutical division, NeonMind has two distinct psilocybin drug development programs targeting obesity. NeonMind's lead candidate, NEO-001, employs psilocybin as an agonist at the serotonin 5- HT2A receptor, which is involved in the hallucinogenic effect of psychedelics. The Company's second drug candidate, NEO-002, employs low-dose psilocybin as an agonist at the 5-HT2C receptor, which controls appetite.
NeonMind and its strategic partners are building NeonMind-branded specialty mental health clinics in Canada that incorporate evidence-backed innovative treatments to address a variety of mental health needs. For more information on NeonMind, go to www.NeonMindBiosciences.com.
CONTACT:
Rob Tessarolo, President & Chief Executive Officer, NeonMind Biosciences Inc.
rob@neonmind.com
Tel: 416-750-3101
The Canadian Securities Exchange has not reviewed, approved nor disapproved the contents of this news release.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or NeonMind's future performance. The use of any of the words "could", "expect", "believe", "will", "projected", "estimated" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on NeonMind's current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, NeonMind's drug development plans, its ability to retain key personnel, and its expectation as to the development of its intellectual property and other steps in its preclinical and clinical drug development constitute forward-looking information. Actual results and developments may differ materially from those contemplated by forward-looking information. Readers are cautioned not to place undue reliance on forward-looking information. The statements made in this press release are made as of the date hereof. NeonMind disclaims any intention or obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as may be expressly required by applicable securities laws.
SOURCE:NeonMind Biosciences Inc.
News Provided by ACCESSWIRE via QuoteMedia
Partnered with SRx Health Solutions and BioScript Solutions to Build Out a Network of NeonMind-branded Specialty Mental Health Clinics Across Canada
NeonMind Biosciences Inc. (CSE:NEON) (OTCQB:NMDBF) (FRA:6UF) ("NeonMind'' or the "Company"), an integrated drug development and wellness company focused on bringing innovative psychedelic-based treatments to people suffering from obesity and mental health disorders, announced today plans to launch 10 specialty mental health clinics over the next 3 years through alliances with SRx Health Solutions and BioScript Solutions, leading Canadian specialty healthcare services and medical treatment providers
Approximately 1 in 10 Canadians use health services annually for mood and anxiety disorders, according to a Canadian government report, Mood and Anxiety Disorders in Canada. Major health care institutions are acknowledging the increasing burden of the crisis and the need to provide support access to treatments, including Ontario Health's Roadmap to Wellness which will invest $3.8 billion into mental health; Veterans Affairs Canada is launching new mental health benefits and insurance companies are providing coverage to new mental health treatments.
New, effective treatments for mood and anxiety disorders have been developed with proven benefits to patients, including intravenous ketamine (IV-Ket) and neurostimulation. These treatments require short visits to a clinic typically lasting 2 hours or less. NeonMind's research reveals there is a lack of available and conveniently located clinics providing these treatments. NeonMind's Specialty Mental Health Clinics division is executing on its strategy to increase availability of these treatments by building out clinic locations with our trusted partners that are leading providers of specialty medical treatments with a network of hundreds of established clinic locations.
"By partnering with SRx Health Solutions and BioScript, we can leverage their established clinic network and operational excellence in specialty medical treatments to introduce our mental health treatments in an expedient and capital efficient manner and importantly, working with an infrastructure that enables scaling" said Rob Tessarolo, President & CEO of NeonMind Biosciences. "With very little upfront costs for each location, we expect to be able to open NeonMind clinics in at least 10 new communities over the next few years and are pleased to offer this referral service to medical doctors and their patients who recognize the benefits of IV-Ket and neurostimulation but are not set up to deliver the treatments in their own clinics."
NeonMind plans to launch its first treatment location this summer in Mississauga, Ontario in 2022. Its innovative business model allows it to launch each location with substantial savings in launch costs by launching within an existing clinic location. The alliances mean NeonMind can avoid high leasehold improvements and overhead and is able to share costs on medical staffing.
Initially NeonMind clinics will offer IV-Ket, a validated treatment that was recently added to the Canadian guidelines. IV-Ket requires a licensed clinic setup and a team of specially trained healthcare professionals which most medical clinics cannot achieve and therefore are not able to provide this treatment. NeonMind is closing the treatment gap by offering medical doctors a trusted referral partner for their patients to get access to IV-Ket.
NeonMind's inaugural specialty mental health clinic will be located at 89 Queensway West, Suite 604, Mississauga, Ontario, L5B 2V2. For more information related to NeonMind's specialty clinics, please email medicalinformation@neonmind.com.
About NeonMind Biosciences Inc.
NeonMind operates two divisions: (i) a pharmaceutical division engaged in drug development of psychedelic compounds with two lead psilocybin-based drug candidates targeting obesity; and (ii) a medical services division focused on launching specialty mental health clinics that integrate psychedelic therapeutics into traditional psychotherapy settings.
In its pharmaceutical division, NeonMind has two distinct psilocybin drug development programs targeting obesity. NeonMind's lead candidate, NEO-001, employs psilocybin as an agonist at the serotonin 5- HT2A receptor, which is involved in the hallucinogenic effect of psychedelics. The Company's second drug candidate, NEO-002, employs low-dose psilocybin as an agonist at the 5-HT2C receptor, which controls appetite.
NeonMind and its strategic partners are building NeonMind-branded specialty mental health clinics in Canada that incorporate evidence-backed innovative treatments to address a variety of mental health needs. For more information on NeonMind, go to www.NeonMindBiosciences.com.
CONTACT:
Rob Tessarolo, President & Chief Executive Officer, NeonMind Biosciences Inc.
rob@neonmind.com
Tel: 416-750-3101
The Canadian Securities Exchange has not reviewed, approved nor disapproved the contents of this news release.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or NeonMind's future performance. The use of any of the words "could", "expect", "believe", "will", "projected", "estimated" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on NeonMind's current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, NeonMind's drug development plans, its ability to retain key personnel, and its expectation as to the development of its intellectual property and other steps in its preclinical and clinical drug development constitute forward-looking information. Actual results and developments may differ materially from those contemplated by forward-looking information. Readers are cautioned not to place undue reliance on forward-looking information. The statements made in this press release are made as of the date hereof. NeonMind disclaims any intention or obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as may be expressly required by applicable securities laws.
SOURCE: NeonMind Biosciences Inc.
News Provided by ACCESSWIRE via QuoteMedia
To Deliver Low Dose Intravenous Ketamine for Mood and Anxiety Disorders, a Recommended Treatment by Canadian Guidelines, Upon Clinic Licensing
NeonMind Biosciences Inc. (CSE:NEON)(OTCQB:NMDBF)(FRA:6UF) ("NeonMind'' or the "Company"), an integrated drug development and wellness company focused on bringing innovative psychedelic-based treatments to people suffering from obesity and mental health disorders, announced today it is setting up to offer low dose intravenous ketamine therapy for mood and anxiety disorders (IV-Ket) as an initial treatment at its recently announced, inaugural specialty mental health clinic location in Mississauga, Ontario, pending clinic licensing
NeonMind's Mississauga clinic represents its initiative to establish and operate a network of NeonMind-branded specialty clinics. These clinics will deliver in demand mental health treatments to underserved areas throughout Canada. Specialty services to be offered will incorporate innovative, evidence-based interventional psychiatric treatments for a variety of mental health disorders.
Rob Tessarolo, President & CEO of NeonMind, commented, "This represents the latest step in our plan to become a specialty mental health clinics operator. We are building a clinic infrastructure that supports psychiatric treatment using innovative medicines such as ketamine, as well as other emerging therapies with strong evidence of efficacy and safety, in an effort to provide long-lasting solutions to a growing population of patients suffering from mental health. Following our recent clinic opening announcements, we are working quickly to stand these facilities up, with our Mississauga location in the final process for equipment setup and licensing."
NeonMind's Site Medical Director for its Mississauga specialty clinic location, Dr. Bhayana, has low dose IV-Ket treatment for mood and anxiety disorders as part of his scope of practice and will be overseeing the clinic with three private infusion rooms and operational capabilities that can support high volumes of IV-Ket treatments. There is now strong clinical evidence that IV-Ket is an efficacious and safe treatment for mood and anxiety disorders which has led to its inclusion as a treatment option in Canadian guidelines. Additional psychedelic-based therapies have a growing body of evidence on their efficacy in treating mental health disorders and NeonMind will look to incorporate these novel therapies as they are authorized. The Mississauga clinic is expected to begin treatment services in the second half of 2022.
NeonMind's inaugural specialty mental health clinic is located at 89 Queensway West, Suite 604, Mississauga, Ontario, L5B 2V2. For more information related to NeonMind's specialty clinics, please email medicalinformation@neonmind.com.
About NeonMind Biosciences Inc.
NeonMind operates two divisions: (i) a pharmaceutical division engaged in drug development of psychedelic compounds with two lead psilocybin-based drug candidates targeting obesity; and (ii) a medical services division focused on launching specialty mental health clinics that integrate psychedelic therapeutics into traditional psychotherapy settings.
In its pharmaceutical division, NeonMind has two distinct psilocybin drug development programs targeting obesity. NeonMind's lead candidate, NEO-001, employs psilocybin as an agonist at the serotonin 5- HT2A receptor, which is involved in the hallucinogenic effect of psychedelics. The Company's second drug candidate, NEO-002, employs low-dose psilocybin as an agonist at the 5-HT2C receptor, which controls appetite.
NeonMind and its strategic partners are building NeonMind-branded specialty mental health clinics in Canada that incorporate evidence-backed innovative treatments to address a variety of mental health needs. For more information on NeonMind, go to www.NeonMindBiosciences.com.
Rob Tessarolo, President & Chief Executive Officer, NeonMind Biosciences Inc.
rob@neonmind.com
Tel: 416-750-3101
Investor Relations:
KCSA Strategic Communications
Scott Eckstein/Tim Regan
neonmind@kcsa.com
Tel: 212-896-1210
The Canadian Securities Exchange has not reviewed, approved nor disapproved the contents of this news release.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or NeonMind's future performance. The use of any of the words "could", "expect", "believe", "will", "projected", "estimated" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on NeonMind's current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, NeonMind's drug development plans, its ability to retain key personnel, and its expectation as to the development of its intellectual property and other steps in its preclinical and clinical drug development constitute forward-looking information. Actual results and developments may differ materially from those contemplated by forward-looking information. Readers are cautioned not to place undue reliance on forward-looking information. The statements made in this press release are made as of the date hereof. NeonMind disclaims any intention or obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as may be expressly required by applicable securities laws.
SOURCE: NeonMind Biosciences Inc.
News Provided by ACCESSWIRE via QuoteMedia
Data Further Validates Psilocybin as a Drug Candidate for Obesity and Supports Development of NeonMind's Drug Programs NEO-001 and NEO-002
NeonMind Biosciences Inc. (CSE:NEON)(OTCQB:NMDBF)(FRA:6UF) ("NeonMind'' or the "Company"), an integrated drug development and wellness company focused on bringing innovative psychedelic-based treatments to people suffering from obesity and mental health disorders, announced today it has released preclinical data demonstrating the efficacy of psilocybin in reducing weight gain in obese subjects. In previous preclinical studies, NeonMind has shown efficacy in reducing weight gain in healthy subjects with normal weight. This latest study suggests a broader therapeutic potential of psilocybin in weight management and supports the current development track of NeonMind's drug candidates
The data from NeonMind's preclinical models revealed a novel finding for its drug candidates: the ability to target visceral fat. Increased visceral fat is linked to poorer cardiometabolic health and reduction in this type of fat is important in weight loss and better overall health outcomes. Additional findings from the preclinical models in obese subjects include:
The positive results further reinforce the drug development opportunity of NeonMind's two lead psilocybin-based drug candidates targeting obesity. Moreover, the novel findings provide opportunities to enhance their commercial profiles. These candidates include NEO-001, which employs psilocybin as an agonist at the serotonin 5- HT2A receptor, and NEO-002, which utilizes low-dose psilocybin as an agonist at the 5-HT2C receptor, which controls appetite.
"These latest findings show psilocybin's ability to modulate weight gain, which is absolutely critical for any drug candidate targeting obesity and weight loss," said Robert Tessarolo, President & CEO of NeonMind. "In two separate rodent studies, we have shown that psilocybin has efficacy in modulating weight in both obese and normal subjects. This is important given visceral fat is associated with increased comorbidities and poorer health outcomes. These findings show promise for the future development of psilocybin-based treatments for obesity, which may also lead to improved cardiovascular and metabolic health."
Dr. Alasdair Barr, primary investigator of NeonMind's preclinical study, commented, "These preclinical studies are bringing to light novel findings in an under-researched psychedelic modality: psilocybin-based weight management. We were able to explore key mechanisms that drive obese behavior and have come away with further evidence that psilocybin could potentially lead to a reduction in weight gain in various patient sub-types."
The manuscript has been submitted to a leading industry peer-reviewed journal for publication.
About NeonMind Biosciences Inc.
NeonMind operates two divisions: (i) a pharmaceutical division engaged in drug development of psychedelic compounds with two lead psilocybin-based drug candidates targeting obesity; and (ii) a medical services division focused on launching specialty mental health clinics that integrate psychedelic therapeutics into traditional psychotherapy settings.
In its pharmaceutical division, NeonMind has two distinct psilocybin drug development programs targeting obesity. NeonMind's lead candidate, NEO-001, employs psilocybin as an agonist at the serotonin 5- HT2A receptor, which is involved in the hallucinogenic effect of psychedelics. The Company's second drug candidate, NEO-002, employs low-dose psilocybin as an agonist at the 5-HT2C receptor, which controls appetite.
NeonMind and its strategic partners are building NeonMind-branded specialty mental health clinics in Canada that incorporate evidence-backed innovative treatments to address a variety of mental health needs. For more information on NeonMind, go to www.NeonMindBiosciences.com.
Rob Tessarolo, President & Chief Executive Officer, NeonMind Biosciences Inc.
rob@neonmind.com
Tel: 416-750-3101
Investor Relations:
KCSA Strategic Communications
Scott Eckstein/Tim Regan
neonmind@kcsa.com
Tel: 212-896-1210
The Canadian Securities Exchange has not reviewed, approved nor disapproved the contents of this news release.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or NeonMind's future performance. The use of any of the words "could", "expect", "believe", "will", "projected", "estimated" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on NeonMind's current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, NeonMind's drug development plans, its ability to retain key personnel, and its expectation as to the development of its intellectual property and other steps in its preclinical and clinical drug development constitute forward-looking information. Actual results and developments may differ materially from those contemplated by forward-looking information. Readers are cautioned not to place undue reliance on forward-looking information. The statements made in this press release are made as of the date hereof. NeonMind disclaims any intention or obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as may be expressly required by applicable securities laws.
SOURCE:NeonMind Biosciences Inc.
News Provided by ACCESSWIRE via QuoteMedia
- Treatment with SLS-005 demonstrated a 46% reduction in tau protein and an 18% reduction in NfL biomarker from baseline values within six months
- Seelos has been selected to present these data at Neuroscience 2023 to be held on November 11-15, 2023 in Washington , D.C.
Seelos Therapeutics, Inc. (Nasdaq: SEEL) ("Seelos"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced encouraging preclinical data from an in vivo study of SLS-005 (trehalose injection, 90.5 mgmL for intravenous infusion) in an aggressive Alzheimer's disease non-human primate model. Seelos has been selected to present a poster of these data at Neuroscience 2023 to be held on November 11-15, 2023 in Washington, D.C.
In this study, the overexpression of tau in older non-human primates (NHPs) was utilized through bilateral AAV induced tauopathy. NHPs in this study were administered either SLS-005 weekly, a single administration of SLS-009 or control. The NHPs receiving SLS-005 demonstrated a 46% reduction in tau protein and an 18% reduction in NfL (neurofilament light chain) protein biomarker from baseline values in a preliminary analysis. NfL is a non-specific biomarker for several neurodegenerative conditions, including Alzheimer's disease, multiple sclerosis, and amyotrophic lateral sclerosis (ALS).
"We believe these data from the SLS-005 cohort are highly encouraging and supports SLS-005 as an active drug that targets key biomarkers, including both a broad-based non-specific CNS biomarker like NfL reduction, and a target-specific biomarker such as tau reduction, within six months. These biomarkers are key emerging targets for reduction to treat Alzheimer's disease and tauopathies," said Krishna Subramanian , Ph.D., Vice President, Non-Clinical Development and Translational Science at Seelos. "We are also currently completing the analysis of the SLS-009 cohort where the initial results appear promising and expect to release that full dataset when available at a future scientific meeting."
Additionally, top-line data from the SLS-005 registrational Phase II/III trial in ALS as part of the HEALEY ALS Platform Trial led by Harvard Medical School at Massachusetts General Hospital is expected to be released in the fourth quarter of 2023.
About SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion)
SLS-005 is a low molecular weight disaccharide (0.342 kDa) that crosses the blood brain barrier and is thought to stabilize proteins and activate autophagy through the activation of Transcription Factor EB (TFEB), a key factor in lysosomal and autophagy gene expression. The activation of TFEB is an emerging therapeutic target for a number of diseases with pathologic accumulation of storage material. In animal models of several diseases associated with abnormal cellular protein aggregation or storage of pathologic material, SLS-005 has been shown to reduce aggregation of misfolded proteins and reduce accumulation of pathologic material. SLS-005 is an investigational treatment and is not currently approved by any health authority for medicinal use.
About Seelos Therapeutics
Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases. The Company's robust portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD), amyotrophic lateral sclerosis (ALS) and spinocerebellar ataxia (SCA), as well as early-stage programs in Huntington's disease, Alzheimer's disease, and Parkinson's disease.
For more information, please visit our website: https://seelostherapeutics.com , the content of which is not incorporated herein by reference.
Forward Looking Statements
Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding the in vivo study of SLS-005, statements regarding SLS-005 's and SLS-009's prospects and potential and statements regarding the timing to release data from the SLS-009 and SLS-005 preclinical studies . These statements are based on Seelos' current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos' business and plans described herein include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies, not being able to move forward with the development of SLS-00 5 or SLS-009 , and not gaining mar keting approvals for SLS-005, SLS-009 and/or its other product candidates; the risk that prior clinical results may not be replicated in future studies and trials (including the risk that the results f rom the prior studies of SLS-005 or SLS-009 may not be replicated or may be materially different from the results of the preclinical data from the in vivo study of SLS-005 and/or SLS-009 ); the risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; the risks associated with the implementation of Seelos' business strategy; the risks related to raising capital to fund its development plans and ongoing operations; the risks related to Seelos' current stock price; as well as other factors expressed in Seelos' periodic filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
Contact Information:
Anthony Marciano
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue, 2 nd Floor
New York , NYÂ 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos
Mike Moyer
Managing Director
LifeSci Advisors, LLC
250 West 55th St., Suite 3401
New York , NYÂ 10019
(617) 308-4306
mmoyer@lifesciadvisors.com
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SOURCE Seelos Therapeutics, Inc.
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Seelos Therapeutics, Inc. (Nasdaq: SEEL) ("Seelos"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced top line data demonstrating clinically meaningful treatment effects across multiple endpoints and a well-tolerated safety profile from the double-blind, placebo-controlled cohort (Part 2) of its Phase II study of SLS-002 (intranasal racemic ketamine) for Acute Suicidal Ideation and Behavior (ASIB) in adults with Major Depressive Disorder (MDD).
SLS-002 versus placebo demonstrated early and persistent reductions in symptoms of depression as assessed by the Montgomery -Ã…sberg Depression Rating Scale (MADRS) 1 . The graph presents results from the mixed model for repeated measures (MMRM) analysis of change from baseline in MADRS total score.
Target enrollment of this study was 220 patients, however, due to financial constraints, only 147 patients diagnosed with MDD requiring psychiatric hospitalization due to significant risk of suicide were randomized. The data from the 147 subjects (67% of target enrollment) were evaluated using the protocol-defined methods of analysis. Due to the limited sample size, the study did not meet the pre-defined primary endpoint (MADRS ANCOVA at 24 hours post dosing). However, assuming the same treatment difference and standard deviation, analyses showed that the study would have achieved statistical significance for the primary endpoint, had the study reached full enrollment (220 patients).
"The analyses of the 147 enrolled subjects in this multicenter, double-blind placebo-controlled trial of SLS-002 demonstrated both meaningful early and persistent improvement in depressive symptoms, as well as clinically meaningful reduction in acute suicidality symptoms relative to standard of care," said Tim Whitaker , M.D., Chief Medical Officer of Seelos. "We believe these results demonstrate the therapeutic potential of SLS-002 to address this huge unmet need and those at risk. We look forward to our discussions with the FDA to align on next steps. In addition, we want to thank the study participants, as well as the clinical trial sites and staff, for their expert and careful care of these high-risk study patients."
Detailed Summary of Key Efficacy Endpoints
Clinically meaningful reduction in acute suicidality was demonstrated with SLS-002 over placebo. Both groups continued to improve over time.
The table represents the observed MADRS summary statistics, including the assessments collected at the safety follow-up visits.
Detailed Summary of Safety Results
SLS-002 was well-tolerated with no new or unique safety signals identified and there were no deaths reported in the study. At least one treatment-emergent adverse event was reported in 52.7% of subjects treated with SLS-002 versus 39.7% treated with placebo; the majority of adverse events were mild or moderate and transient in nature. The most common treatment-emergent adverse events (≥5% and >placebo) were dizziness (18.9% versus 2.7%), euphoric mood (6.8% versus 0%) and suicidal ideation (5.4% versus 2.7%). There were 5 serious adverse events (3 with SLS-002, 2 with placebo), all for suicidality, all judged unrelated to the study drug, and all resolved.
Specific scales were utilized to measure the three most common known adverse events associated with ketamine treatments, which are dissociation, hemodynamic effects and sedation. The data below support that SLS-002 may reduce the frequency and severity of these most common effects compared to what is reported with other ketamine treatments.
Clinician-Administered Dissociative States Scale (CADSS) 6
Hemodynamic Effects
Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S) 7
"We believe these data are remarkable. We expect to move forward with our development of SLS-002 after the end of Phase II meeting with the FDA," said Raj Mehra Ph.D., Chairman and Chief Executive Officer of Seelos. "The improvements with SLS-002 were robust and continued to improve across efficacy scales with 5 doses over the two-week treatment period. In addition to the data on efficacy, the differentiated and well-tolerated safety profile of SLS-002 highly underscores this product candidate's uniqueness and potential for the treatment of ASIB in MDD. We look forward to advancing this therapy toward a potential first approval for an important unmet need for this patient population, especially considering that 2022 experienced the highest number of suicides in U.S. history."
Webcast Information
Seelos will host a webcast today, Wednesday, September 20 th , at 8 a.m. ET , to discuss the results. On the call from Seelos will be Raj Mehra, Ph.D., Chairman and CEO, and Tim Whitaker , M.D., Chief Medical Officer.
Additionally, David V. Sheehan , M.D., the Distinguished University Health Professor Emeritus at the University of South Florida College of Medicine, will be on the call as well to discuss this data.
Webcast for live and replay: https://lifescievents.com/event/seelos-2
A replay of the webcast will be available shortly following the presentation.
This study randomized 147 subjects diagnosed with MDD requiring psychiatric hospitalization due to significant risk of suicide and severe depression as confirmed by the rating scales as discussed above. In addition, subjects had to have at least one suicide attempt. Â For more information on entry criteria visit https://clinicaltrials.gov/study/NCT04669665?term=sls-002&rank=1 .
After admission to the emergency room or hospital, each subject participated in a 1- to 2‑day screening phase, a 16-day treatment phase, including clinical standard of care, during which the study drug was administered 2 times per week (total of 5 doses), and a 2-week safety follow-up phase for a total of up to 5 weeks of study participation. Subjects were treated as inpatients for approximately 7 days (including screening), and assuming the subject met readiness for discharge criteria, were discharged on Day 6 to continue the trial as outpatients. At study completion, all subjects were well-connected with follow-up care to ensure their safety.
Per the Centers for Disease Control and Prevention (CDC) provisional data , the 49,449 suicides in the U.S. in 2022 represented the highest number of suicides recorded in U.S. history and unfortunately, the medical community still lacks an FDA approved therapeutic to treat the symptoms of suicidality. According to the CDC , in 2020, suicides and non-fatal self-harm cost the U.S. over $500 billion in medical and work-loss costs, value of statistical life, and quality of life costs. Suicidal patients who present suicidal ideation and behavior symptoms at an Emergency Department and can be held in the Emergency Department for several days while awaiting an inpatient psychiatric bed. Currently in the U.S., there is a shortage of over 120,000 inpatient psychiatric beds and the average length of hospitalization for a suicidal patient is 10 days.
If you or a loved one are having thoughts of suicide, please seek immediate medical help, go to your nearest emergency room, call the Suicide and Crisis Lifeline at 988 or 1-800-273-8255 (TALK).
1 Montgomery -Ã…sberg Depression Rating Scale (MADRS) scale range 0-60, higher scores indicating more severe depression.
2 Least Squares (LS) Means are means estimated from a linear model that are adjusted for other effects defined in the model.
3 ANCOVA is short for Analysis of Covariance. The analysis of covariance is a combination of an ANOVA and a regression analysis.
4 Sheehan-Suicidality Tracking Scale (S-STS) is a clinician-rated scale, which includes 13 suicidality items that are rated on a scale ranging from 0 (not at all) to 4 (extremely), which yields a total score ranging from 0 to 52.
5 Clinical Global Impression of Severity for Suicidal Ideation and Behavior (CGIS-SI/B) is a 5-point clinician-rated measure of suicidality-specific symptom severity, ranging from 1 (not at all suicidal) to 5 (among the most extremely suicidal).
6 Clinician-Administered Dissociative States Scale (CADSS) is a standardized instrument used to measure present-state dissociative symptoms. The scale includes 23Â subjective items to be answered by the subject according to a 5-point scale (0 = not at all, 1Â =Â mild, 2 = moderate, 3 = severe, and 4 = extreme). CADSS total score range is 0-92; a higher score reflects a more severe condition.
7 Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S) is a 6 point scale with a score of 5 defined as responds readily to name, and a score of 0 defined as does not respond to painful stimulus.
About SLS-002
SLS-002 is intranasal racemic ketamine with two investigational new drug applications for the treatment of Acute Suicidal Ideation and Behavior in Major Depressive Disorder and in Post-Traumatic Stress Disorder. SLS-002 was originally derived from a Javelin Pharmaceuticals, Inc./Hospira, Inc. program with 16 clinical studies involving approximately 500 subjects. Seelos looks to address an unmet need for a therapy to treat suicidality in the U.S. with SLS-002. Traditionally, anti-depressants have been used in this setting but many of the existing treatments are known to contribute to an increased risk of suicidal thoughts in some circumstances, and if they are effective, it often takes weeks for the full therapeutic effect to be manifested. Based on information gathered from the databases of the Agency for Healthcare Research and Quality, there were more than 1,000,000 visits to emergency rooms for suicide attempts in 2019 in the U.S. alone. Experimental studies suggest ketamine has the potential to be a rapid, effective treatment for refractory depression and suicidality.
About Seelos Therapeutics
Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases. The Company's robust portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD), amyotrophic lateral sclerosis (ALS) and spinocerebellar ataxia (SCA), as well as early-stage programs in Huntington's disease, Alzheimer's disease, and Parkinson's disease.
For more information, please visit our website: http://seelostherapeutics.com , the content of which is not incorporated herein by reference.
Forward Looking Statements
Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding Part 2 of the Phase II study of SLS-002, statements regarding SLS-002's prospects and potential, statements regarding any potential market opportunity for SLS-002, statements to the effect that Part 2 of the Phase II study of SLS-002 would have achieved statistical significance for the primary endpoint had the study reached full enrollment and statements regarding Seelos' development plans for SLS-002 and any planned meetings and discussions with the FDA. These statements are based on Seelos' current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos' business and plans described herein include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies, not being able to move forward with the development of SLS-002 after the anticipated end of Phase II meeting with the FDA, and not gaining marketing approvals for SLS-002 and/or its other product candidates; the risk that prior clinical results may not be replicated in future studies and trials (including the risk that the results from the prior studies of SLS-002 may not be replicated or may be materially different from the results of Part 2 of the Phase II study of SLS-002); the risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; the risks associated with the implementation of Seelos' business strategy; the risks related to raising capital to fund its development plans and ongoing operations; the risks related to Seelos' current stock price; as well as other factors expressed in Seelos' periodic filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
Contact Information:
Anthony Marciano
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos
Mike Moyer Managing Director
LifeSci Advisors, LLC
250 West 55th St., Suite 3401
New York, NY 10019
(617) 308-4306
mmoyer@lifesciadvisors.com
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COMPASS Pathways plc (Nasdaq: CMPS) ("COMPASS"), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the appointment of Daphne Karydas to its Board of Directors, effective September 18, 2023. Ms. Karydas is President and Chief Financial Officer at Flare Therapeutics Inc., a privately held biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases.
"Daphne is an ideal match for the COMPASS Pathways Board of Directors as we progress our phase 3 COMP360 psilocybin program in treatment-resistant depression and our phase 2 programs in anorexia nervosa and post-traumatic stress disorder," said George Goldsmith, Chairman of the COMPASS Pathways Board of Directors. "Her deep industry experience, her interdisciplinary approach to implementing growth strategies for biopharma, and her understanding of investor priorities will help ensure that the company is on firm financial and strategic ground as we seek to bring much needed innovation to patients suffering with serious mental health conditions. We are delighted to welcome her."
"I am excited to join the COMPASS board as the company advances its pioneering COMP360 psilocybin program," said Ms. Karydas. "Its recent impressive fundraising round was validation of both the potential of psychedelic medicine and the rigorous, evidence-based approach the company is pursuing. I am looking forward to working with the board and the executive team, and doing my part to advance COMPASS's mission."
Ms. Karydas has over two decades of experience serving in financial and operations leadership roles with biopharmaceutical and asset management companies. Prior to joining Flare Therapeutics in October 2021, Ms. Karydas served as Chief Financial Officer and Treasurer of Syndax Pharmaceuticals, Inc., and in financial and strategy roles at Allergan plc, serving as Senior Vice President, Corporate Financial Planning & Analysis and Strategy at the time of the company's acquisition by AbbVie in May 2020. She also previously held healthcare analyst roles with JPMorgan Asset Management, The Boston Company Asset Management, and Goldman Sachs Asset Management, and was a vice president in the healthcare group of the investment banking division of Goldman, Sachs & Co.
In addition to her experience as an executive, Ms. Karydas also serves as a board member of Mineralys Therapeutics, a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease and other diseases driven by abnormally elevated aldosterone. She previously served on the board of LogicBio Therapeutics, a clinical-stage genomic medicine company that was acquired in 2022 by the rare disease business group within AstraZeneca, and Elicio Therapeutics, Inc., a biotechnology company focused on lymph-node targeted immunotherapies to defeat cancer and infectious diseases.
Ms. Karydas earned BS and MS degrees in chemical engineering from the Massachusetts Institute of Technology and worked as a chemical engineer at Merck & Co. following her studies. She earned her MBA from Harvard Business School.
About COMPASS Pathways
COMPASS Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). We have commenced a phase 3 clinical program of COMP360 psilocybin therapy in TRD, the largest randomized, controlled, double-blind psilocybin therapy clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p www.compasspathways.com .
Forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as "will", "may", "might", "could", "would", "should", "expect", "intend", "plan", "objective", "anticipate", "believe", "contemplate", "estimate", "predict", "potential", "continue" and "ongoing," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, our expectations regarding our financial position and funding requirements; COMPASS's expectations regarding its ongoing preclinical work and clinical trials and development efforts, the potential for COMPASS's pivotal phase 3 program or other trials to support regulatory filings and approvals; and our expectations regarding the potential benefits of our COMP360 psilocybin treatment. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond COMPASS's control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.
These risks, uncertainties, and other factors include, among others: market risks and other market conditions; clinical development is lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; we will require substantial additional funding to achieve our business goals and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our product development efforts; our efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for COMP360 or any of future product candidates may be unsuccessful; establishing, maintaining, defending and enforcing our patents and other intellectual property rights covering our investigational COMP360 psilocybin therapy may be challenging and costly and our efforts to protect our patents and other intellectual property rights may be unsuccessful; our efforts to commercialize and to obtain coverage and reimbursement for our investigational COMP360 psilocybin therapy, if approved, may be unsuccessful; and those risks and uncertainties described under the heading "Risk Factors" in COMPASS's most recent annual report on Form 10-K or quarterly report on Form 10-Q and in other reports we have filed with the U.S. Securities and Exchange Commission ("SEC"), which are available on the SEC's website at www.sec.gov . HYPERLINK "www.sec.gov" Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS's current expectations and speak only as of the date hereof.
Enquiries
Media: Amy Lawrence, media@compasspathways.com, +44 7813 777 919
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324
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lobe sciences ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a North American Biopharmaceutical Company committed to discovering and developing patient-focused medicines for Orphan and Rare diseases announced today that Mathew Lee will join the organization as Chief Financial Officer, effective September 18, 2023.
"Appointing Mathew is part of our overall long-term strategy of enlisting top talent to lead our senior executive team while supporting our ongoing R&D and commercialization initiatives," said Phil Young, Chairman and Chief Executive Officer of Lobe. "Mathew's proven financial experience in the capital markets will play a direct role in allowing us to achieve our business goals. I also want to thank Brian Zasitko for his work as CFO over these last three years. We are very pleased to have him continuing on as advisor during the transition."
"Joining Lobe as CFO represents an incredible opportunity to contribute to the success of the Lobe team and I am excited to be joining an already successful world class management team," said Mathew, the Company's new Chief Financial Officer. "My near-term focus will be building out the back office and support structure and supporting the Companies commercial activities moving forward."
Mathew has over 15 years of experience as a finance executive. Mathew currently serves as president of Manning Lee Management Ltd., a management consulting firm providing CFO services to publicly traded companies. Mathew specializes in providing M&A, accounting, management, securities regulatory compliance, and corporate secretarial services to companies listed on the TSX-V, CSE, and OTC. Mathew is a CPA Charterholder and earned a B.Comm from the University of British Columbia.
About lobe sciences ltd.
Lobe Sciences is a biopharmaceutical company focused on developing patient-friendly, practical psychedelic medicines. The Company, through collaborations with industry-leading partners, is engaged in drug research and development using sub-hallucinatory doses of proprietary compounds to treat Orphan diseases. Each of our New Chemical Entities, L-130 and L-131, are being developed to address unmet medical needs such as Chronic Cluster Headaches and other Orphan diseases. Additionally, we will be commercializing Altemiaâ„¢ for the treatment of patients diagnosed with Sickle Cell Disease.
About Altemiaâ„¢
Altemiaâ„¢ is a trademark registered to Altemia and Company, LLC of Stuart Florida. Altemiaâ„¢ is the brand name of a patent pending oral emulsion consisting of a proprietary mixture of polyunsaturated fatty acid triglyceride esters clinically evaluated to reduce inflammation associated in adults with SCD. The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is "a food which is formulated to be consumed under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation." SCD is among a few inborn errors of metabolism specifically named in legislation that qualifies as treatable with medical foods. More information is available at http://altemiascd.com/ . This product should not be confused with a previous product development program with a similar name. That program also called Altemia (SC411) was the project name used during the development of a drug product to treat SCD in children.
About Sickle Cell Disease
SCD is a group of hereditary red blood cell disorders. Healthy red blood cells are round, and they move through small blood vessels to carry oxygen to all parts of the body. In someone who has SCD, the red blood cells (RBC) become inflamed under certain stress conditions resulting in among other symptoms, an increase of C-Reactive Protein (a biomarker for SCD). Inflammation causes the RBC's membrane to become hard and sticky, and this tends to slow or even block blood flow in the blood vessels (capillaries) of the limbs and organs. This slowing of the blood cells causes a cascade of events that results in pain and vaso-occlusive event (VOC). The sickle cells also die earlier than normal red blood cells and the bone marrow cannot make enough new red blood cells to replenish the dying ones, which causes a constant shortage of red blood cells called anemia. Blocked blood flow may cause pain and other serious problems such as infection, acute chest syndrome and stroke. Populations that suffer from SCD have a shortened life span. According to the CDC, it is estimated that SCD affects approximately 100,000 individuals in the United States, occurring among approximately 1 out of every 500 Black or African American births and 1 out of every 36,000 Hispanic American births. A similar number of patients are affected in Europe. There are millions of patients in the Middle East, Africa and India. Lobe plans to sell the product globally, either directly or through partners.
NEITHER THE CSE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ACCURACY OR ADEQUACY OF THIS RELEASE.
This does not constitute an offer to sell or a solicitation of offers to buy any securities.
Forward Looking Statements
This news release contains forward-looking statements relating to the future operations of the Company and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will," "may," "should," "anticipate," "expects" and similar expressions. All statements other than statements of historical fact included in this news release (including, without limitation, statements regarding the future plans and objectives of the Company, research and development using psychedelic compounds, and the development of innovative devices and delivery mechanisms to improve mental health and wellness) are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. Readers are cautioned that assumptions used in the preparation of the forward-looking statements may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company, including changes to the regulatory environment; that the Company's drug research and development activities may be unsuccessful; that drugs and medical devices produced by, or on behalf of, the Company, may not work in the manner intended or at all, and may subject the Company to product liability or other liability claims; that the Company may not be able to attain the Company's corporate goals and objectives; and other risk factors detailed in the Company's continuous disclosure filings from time to time, as available under the Company's profile at www.sedar.com . As a result, the Company cannot guarantee that any forward-looking statement will materialize and the reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made only as of the date of this news release and the Company does not intend to update any of the included forward-looking statements except as expressly required by applicable Canadian securities laws.
Drug development involves long lead times, is very expensive and involves many variables of uncertainty. Anticipated timelines regarding drug development are based on reasonable assumptions informed by current knowledge and information available to the Company. Every patient treated on future studies can change those assumptions either positively (to indicate a faster timeline to new drug applications and other approvals) or negatively (to indicate a slower timeline to new drug applications and other approvals). This news release may contain certain forward-looking statements regarding anticipated or possible drug development timelines. Such statements are informed by, among other things, regulatory guidelines for developing a drug with safety studies, proof of concept studies, and pivotal studies for new drug application submission and approval, and assumes the success of implementation and results of such studies on timelines indicated as possible by such guidelines, other industry examples, and the Company's development efforts to date. In addition to the risk factors set out above and those detailed in the Company's continuous disclosure filings from time to time, as available under the Company's profile at www.sedar.com , other factors not currently viewed as material could cause actual results to differ materially from those described in the forward-looking statements. Although Lobe has attempted to identify important risks and factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors and risks that cause actions, events or results not to be anticipated, estimated or intended. Accordingly, readers should not place any undue reliance on forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230918888260/en/
For further information:
lobe sciences ltd.
Philip J Young, CEO
info@lobesciences.com
Tel: (949) 505-5623
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