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London, UK 3 November 2021 COMPASS Pathways plc (Nasdaq: CMPS) ("COMPASS"), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced it will be conducting a phase II clinical trial to assess the safety and tolerability of COMP360 psilocybin therapy in post-traumatic stress disorder (PTSD). The study expands COMPASS's research pipeline in psilocybin therapy with COMP360, the company's proprietary formulation of synthetic psilocybin which COMPASS is currently developing for treatment-resistant depression.

The phase II, multicentre, fixed-dose open label COMP201 study will enrol 20 participants to evaluate the safety and tolerability of COMP360 psilocybin therapy in people who suffer with PTSD resulting from trauma experienced as adults. The study will begin at The Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King's College London. Participants will receive a single 25mg dose of COMP360 psilocybin, given in conjunction with specialist psychological support, in line with the COMP360 psilocybin therapy protocol, and will be followed up for 12 weeks. The primary endpoint of the study is to assess the safety of COMP360 psilocybin therapy. Secondary endpoints will measure efficacy in improving PTSD symptoms, functionality, and quality of life.

George Goldsmith, CEO and Co-founder, COMPASS Pathways, said, "We have made great progress in developing COMP360 psilocybin therapy for patients suffering with treatment-resistant depression, and are pleased to be able to expand development into the indication of PTSD, another area of significant unmet need. As many as one in 20 people in the UK suffer with PTSD and up to 40% of those are not helped by existing treatments. This is an urgent problem and we are determined to do what we can to transform mental health care and bring new, evidence-based therapies to those who so desperately need them."

Dr James Rucker, Consultant Psychiatrist and Senior Clinical Lecturer in Psychopharmacology at King's IoPPN, and Principal Investigator of the study, said, "The effects of PTSD can be extremely debilitating and current treatments aren't always effective. The clinical potential of psilocybin therapy is notable and thus a trial investigating it in PTSD is timely and necessary. We hope that, in time, our work will offer a new form of treatment for the severe and distressing symptoms that those with PTSD suffer so much from."

PTSD is a mental health condition that can impact quality of life and lead to diminished cognitive and psychosocial functioning, fractured relationships, inability to maintain employment, substance abuse, high healthcare utilisation costs, increased depression, and suicide risk. People who experience PTSD may relive their traumatic experience(s) through nightmares and flashbacks, have difficulty sleeping, and feel detached or estranged. i

The Adult Psychiatric Morbidity Survey estimated that one in 20 people in the UK suffer from PTSD, with similar rates for men and women. ii The symptoms of PTSD are often severe and long lasting and current treatment approaches are ineffective for many patients. First line treatment includes psychological interventions such as trauma-focused cognitive behavioural therapy followed by pharmacological approaches such as selective serotonin-reuptake inhibitors (SSRIs). iii ,iv Unfortunately, about 40% of those with PTSD will not improve with this treatment. v ,vi The PTSD Psychopharmacology Working Group recently described current treatment outcomes as "a crisis" and called for novel, effective and efficient trauma-focused interventions to be developed. vii

--Ends--

About COMPASS Pathways

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care 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 US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we are currently conducting a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. We are headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. www.compasspathways.com

Availability of other information about COMPASS Pathways

Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

About King's College London and the Institute of Psychiatry, Psychology & Neuroscience

King's College London is one of the top 35 UK universities in the world and one of the top 10 in Europe (QS World University Rankings, 2020/21) and among the oldest in England. King's has more than 31,000 students (including more than 12,800 postgraduates) from some 150 countries worldwide, and 8,500 staff. King's has an outstanding reputation for world-class teaching and cutting-edge research. The Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King's is the premier centre for mental health and related neurosciences research in Europe. It produces more highly cited outputs (top 1% citations) on mental health than any other centre (SciVal 2019) and on this metric we have risen from 16th (2014) to 4th (2019) in the world for highly cited neuroscience outputs. World-leading research from the IoPPN has made, and continues to make, an impact on how we understand, prevent and treat mental illness and other conditions that affect the brain. www.kcl.ac.uk/ioppn @KingsIoPPN


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 "may", "might", "will", "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, the safety or efficacy of COMP360 psilocybin therapy as a treatment for depression or post-traumatic stress disorder, COMPASS's business strategy and goals, COMPASS's ability to continue to advance its research, including COMP360, COMPASS's expectations regarding the benefits of its psilocybin therapy, including COMP360 and COMPASS's ability to advance new psychedelic compounds in other areas of unmet mental health need. 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: preclinical research and clinical development is lengthy and uncertain, and therefore our preclinical studies and clinical trials may be delayed or terminated, or may never advance to or in the clinic; and those risks and uncertainties described under the heading "Risk Factors" in COMPASS's annual report on Form 20-F filed with the US Securities and Exchange Commission (SEC) on 9 March 2021 and in subsequent filings made by COMPASS with the SEC, which are available on the SEC's website at 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: Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324




i US Department of Veteran Affairs (2021). PTSD: National Center for PTSD [Online]. Available at: https://www.ptsd.va.gov/understand/common/common_adults.asp [Accessed 01 November 2021]

ii McManus S, Bebbington P, Jenkins R, Brugha T. (eds.) (2016) Mental health and wellbeing in England: Adult Psychiatric Morbidity Survey 2014. Leeds: NHS Digital. p107

iii National Institute for Health and Care Excellence (2018). Post-traumatic stress disorder, NICE guideline [NG116] [Online]. Available at: https://www.nice.org.uk/guidance/ng116 [Accessed 01 November 2021]

iv American Psychological Association (2017). Clinical Practice Guideline for the Treatment of Posttraumatic Stress Disorder (PTSD) in Adults [Online]. Available at: https://www.apa.org/ptsd-guideline [Accessed 01 November 2021]

v Krediet E, Bostoen T, Breeksema J, et al. Reviewing the Potential of Psychedelics for the Treatment of PTSD, International Journal of Neuropsychopharmacology. 2020; 23(6) 385-400

vi Berger W, Mendlowicz MV, Marques-Portella C, et al. Pharmacologic alternatives to antidepressants in posttraumatic stress disorder: a systematic review. Prog Neuropsychopharmacol Biol Psychiatry. 2009;33(2):169-180

vii Krystal JH, Davis LL, Neylan TC, et al. It Is Time to Address the Crisis in the Pharmacotherapy of Posttraumatic Stress Disorder: A Consensus Statement of the PTSD Psychopharmacology Working Group [published correction appears in Biol Psychiatry. 2018 Feb 1;83(3):296]. Biol Psychiatry. 2017;82(7):e51-e59



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Seelos Therapeutics Releases the Itinerary for its Research and Development Update Conference Call and Webcast to be Held on December 15, 2022

- Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today released the itinerary for its research and development update conference call and webcast to be held on Thursday, December 15 th from 1pm to 3pm ET .

(PRNewsfoto/Seelos Therapeutics, Inc.)

Registration is available at https://lifescievents.com/event/seelos-therapeutics-kol-event/ , and https://seelostherapeutics.com/registration-for-12-15-rd-update-webcast/ .

Itinerary for the Research and Development Update Conference Call and Webcast

SLS-002 (intranasal racemic ketamine)

We will hear an update from Evan P. Cohen , MD, Medical Director and Chairman of Emergency Services at Montefiore St. Luke's Cornwall Hospital in Newburgh, New York since he participated in our Key Opinion Leader (KOL) call in April. He will share his experience treating psychiatric patients in his emergency department and in prescribing ketamine. Dr. Cohen will also share trends he has witnessed over the past several years treating imminently suicidal patients and potential new directives to address the current issues in the treatment of mental health.

Raj Mehra, Ph.D., Chairman and CEO of Seelos, and Tim Whitaker , MD, Chief Medical Officer of Seelos, will provide an update of the ongoing registration directed study of SLS-002 in Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).

Michael Cozart , Managing Partner at LifeSci Consulting, will discuss recently completed market research of the potential unmet need and market opportunity for SLS-002 in China , Japan , and Korea.

SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion)

Raj Mehra, Ph.D. will provide an update of the ongoing registration directed studies of SLS-005 in amyotrophic lateral sclerosis (ALS) and spinocerebellar ataxia (SCA).

Jeffrey H. Kordower , Ph.D., Founding Director, ASU-Banner Neurodegenerative Disease Research Center (NDRC) at Arizona State University , will discuss recent developments Seelos has made with SLS-005 in Huntington's disease and Alzheimer's disease.

SLS-004 and SLS-007 (gene therapy approaches for Parkinson's disease)

Krishna Subramanian , Ph.D., Vice President, Non-Clinical Development and Translational Science at Seelos, will discuss recent data and Raj Mehra, Ph.D. will discuss next steps for the programs.

About Evan P. Cohen MD

Evan P. Cohen , MD is Medical Director & Chairman of Emergency Services at Montefiore St. Luke's Cornwall Hospital in Newburgh, New York . Dr. Cohen is an emergency medicine physician serving the NYC area for more than 10 years. Dr. Cohen is Board Certified by the American Board of Emergency Medicine. He received his bachelor's degree of science from Syracuse University in 2003 and graduated from the State University of New York, Upstate Medical University in 2007. He completed his residency in Emergency Medicine at Cooper University Hospital in Camden, New Jersey in 2010 and has been in practice for 12 years.

About Jeffrey H. Kordower , Ph.D.

Jeffrey Kordower is the founding director of the ASU-Banner Neurodegenerative Disease Research Center and endowed chair as The Charlene and J. Orin Edson Distinguished Director at the Biodesign Institute at ASU. He has been a pioneer in the field of neural transplantation techniques and his pathbreaking investigations into the underpinnings of neurodegenerative disease have made him a leader in the field. Kordower's interests include the study of gene and stem cell therapies, disease pathogenesis including the morphological and molecular changes during the course of neurodegeneration, learning and memory, and aging. He has also been a pioneer in the field of neural transplantation techniques. He comes to ASU from the Rush University Medical Center in Chicago , where he was faculty member for more than 30 years. He received his Ph.D. from The City University of New York .

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. The clinical development program for SLS-002 includes two parallel healthy volunteer studies (Phase I), followed by pivotal registration studies after meeting with the FDA. 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 SLS-005

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. 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 has previously received Orphan Drug Designation for the treatment of SCA type 3 from the U.S. Food and Drug Administration and from the European Medicines Agency in the EU. SLS-005 is an investigational treatment and is not currently approved by any health authority for medicinal use.

About SLS-004

SLS-004 is a novel epigenome-editing approach to modulate expression of SNCA gene mediated by modification of DNA-methylation. SLS-004 utilizes an all-in-one lentiviral vector harboring dCas9-DNA methyltransferase 3A (DNMT3A) to enrich DNA-methylation within CpGs island at the SNCA intron 1 region. The system resulted in a precise and fine-tuned downregulation (30%) of SNCA overexpression in hiPSC-derived dopaminergic neurons from a PD patient with the triplication of the SNCA locus (SNCA-Tri). Most importantly, the reduction of SNCA expression mediated by the developed system was sufficient to ameliorate disease related cellular phenotypes. The in vitro studies achieved several key milestones, including the establishment that DNA hypermethylation at SNCA intron 1 allows an effective and sufficient tight downregulation of SNCA expression levels and suggests the potential of this target sequence combined with the CRISPR-dCas9 technology as a novel epigenetic-based therapeutic approach for PD.

About SLS-007

SLS-007 is a family of rationally designed peptide inhibitors that target the non-amyloid component core (NACore) of α-synuclein to inhibit protein aggregation in patients with PD. The overexpression of α-synuclein leads to the formation of α-synuclein aggregates which comprise Lewy bodies and Lewy neurites which are the hallmarks of the pathology in brains of patients with PD. Recent in vitro and cell culture research have shown that SLS-007 has the potential to stop the propagation and seeding of α-synuclein aggregates.

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 the topics expected to be discussed on the call, Seelos' ability to complete clinical studies for its product candidates, and Seelos' ability to efficiently execute clinical and pre-clinical programs. These statements are based on Seelos' current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos' business include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies, and not gaining marketing approvals for its product candidates, the risk that prior clinical results may not be replicated in future studies and trials, 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 a new business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos' current stock price, risks related to the global impact of COVID-19, 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, 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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SOURCE Seelos Therapeutics, Inc.

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