Psychedelics

Mydecine Innovations Group an emerging biopharma and life sciences company committed to the research, development, and acceptance of alternative nature-sourced medicine for mainstream use, announced that it has engaged ethica CRO a full-service Contract Research Organization that conducts and manages ethical clinical research on drugs, biologics, medical devices and more, as the contract research organization for ...

Mydecine Innovations Group (CSE: MYCO) (OTC: MYCOF) ("Mydecine" or the "Company"), an emerging biopharma and life sciences company committed to the research, development, and acceptance of alternative nature-sourced medicine for mainstream use, announced that it has engaged ethica CRO ("ethica CRO"), a full-service Contract Research Organization ("CRO") that conducts and manages ethical clinical research on drugs, biologics, medical devices and more, as the contract research organization ("CRO") for its upcoming Phase 2A PTSD clinical trials.

ethica CRO is a full-service, global CRO that provides drug development services to biopharmaceutical companies in clinical trials. ethica CRO provides a complete range of clinical study management and biometrics services for clinical research phases I through IV. Since its inception in 2002, ethica CRO has dedicated its efforts to bring a new dimension to the clinical research industry, the ethical dimension, focused on integrating research participants as partners in research rather than simply subjects of research. ethica CRO was the first CRO in the world to be accredited for its human research protection program in 2006 and is the only CRO in the world to have achieved accreditation from three different accrediting bodies

"We are excited to bring on a high-caliber partner in ethica CRO, which has extensive expertise in managing clinical studies to the highest standards of ethical and clinical practice, as the CRO for Mydecine's upcoming Phase 2A PTSD clinical trials," commented Josh Bartch, CEO of Mydecine Innovations Group. "Engaging ethica CRO is one of the key pieces of our preparations as we explore how the brain responds to psychedelics and develop a better understanding of the biological underpinnings created by the psychedelic experience. We maintain that their insight and unparalleled experience in trials of this nature provide the best opportunity to further drive Mydecine's clinical development. We believe that with ethica CRO's deep clinical experience, and through our achievements in trial preparation, we are optimally positioned for our upcoming Phase 2A PTSD clinical trials in Veterans in Canada and the United States."

ethica CRO's dedication to research participant protection made it a partner of choice for the Canadian Department of National Defence. ethica CRO has participated in a series of clinical development programs with the Canadian DND and various NATO allies, most notably synthetic cannabinoids in the treatment of PTSD, injectable antidotes to chemical weapons, and skin decontamination kits for neutralizing chemical warfare agents.

"Psychedelics and psychedelic-assisted therapies are rapidly proving to be some of the most exciting developments in mental health treatment in decades," said Murray Jensen, Managing Director of ethica CRO. "Mydecine's ambitious approach to researching and tackling the mental health challenges facing veterans and other frontline workers aligns with our values and mission at ethica and we are excited to hit the ground running with the Mydecine team as they push forward in their pursuit to transform mental health."

Mydecine's international Phase 2A clinical trials will focus on psilocybin-assisted psychotherapy to treat chronic PTSD in veterans and EMS personnel. The research will take place at Leiden University Medical Centre in the Netherlands; the University of Western Ontario; and the University of Alberta, with other clinical sites on the horizon in the USA, Europe, and Australia. Through these trials, Mydecine hopes to establish the safety and efficacy of psychedelic administered psychotherapy in a safe and supervised setting, utilizing strict protocols approved by research ethics boards and build upon the body of work that has led to psilocybin-assisted psychotherapy to receive "breakthrough" status by the FDA.

About Mydecine Innovations Group
Mydecine Innovations Group™ is an emerging biopharma and life sciences company dedicated to developing and commercializing innovative solutions for treating mental health challenges and enhancing wellbeing. The company's world-renowned medical and scientific advisory board is advancing a robust R&D pipeline of psychedelic derived therapeutics, novel compounds, therapies, and controlled drug delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, extract, and analyze natural and synthetic psychedelic compounds with full government approval through Health Canada. Mydecine's portfolio companies Mydecine Health Sciences™, Mindleap Health™, and NeuroPharm™ position the company at the forefront of disruptive modern medicine.

Learn more at: https://www.mydecine.com/ and follow us on Facebook , Twitter , and Instagram .

About ethica CRO Inc.
Founded in 2002, ethica CRO is a full-service contract research organization (CRO) that conducts all clinical phases of ethical research for new and innovative treatments on behalf of the pharmaceutical, biotechnology, medical device and natural health product industries. ethica CRO was the first Contract Research Organization (CRO) in the world to be accredited for its human research protection program in 2006 and is the only CRO in the world to have achieved accreditation from three different accrediting bodies. Human research protection program (HRPP) accreditation by an independent, industry-recognized organization confirms that an organization's processes ensure the respect and protection of research participants, and that its services meet or exceed industry standards.

Learn more at: www.ethicaCRO.com and follow us on Twitter and LinkedIn .

Mydecine Innovations Group Media Contacts
Anne Donohoe / Nick Opich
KCSA Strategic Communications
adonohoe@kcsa.com / nopich@kcsa.com
212-896-1265 / 212-896-1206

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com

Corp Communication:
Charles Lee, Investor Relations
corp@mydecineinc.com
+1 720-277-9879

For further information about Mydecine Innovations Group, Inc., please visit the Company's profile on SEDAR at www.sedar.com or visit the Company's website at www.mydecine.com .

The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof. This news release contains forward-looking statements, which relate to future events or future performance and reflect management's current expectations and assumptions. Such forward-looking statements reflect management's current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company's ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company's products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation. This news release does not constitute an offer to sell securities and the Company is not soliciting an offer to buy securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. This news release does not constitute an offer of securities for sale in the United States. These securities have not and will not be registered under United States Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States or to a U.S. Person unless so registered, or an exemption from registration is relied upon.


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Awakn Life Sciences Files Patent Application for a New Class of Entactogen-Like Molecules to Treat a Broad Range of Addictions

Awakn Life Sciences Files Patent Application for a New Class of Entactogen-Like Molecules to Treat a Broad Range of Addictions

Novel Entactogen NCE Series Enhances the Potential for Improved Treatment of Addiction

Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ('Awakn'), a biotechnology company, researching, developing and delivering psychedelic therapeutics to treat addiction, announces the filing of a patent application for a new chemical series of entactogen-like molecules, further strengthening Awakn's intellectual property portfolio and pipeline for the treatment of a broad range of addictions including, but not limited to substance addictions such as Alcohol, and behavioural addictions, such as Gambling Disorder and Compulsive Sexual Behaviour.

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Levitee Labs appoints Jenkins, Lahijani as directors

Levitee Labs appoints Jenkins, Lahijani as directors

Levitee Labs Inc. (CSE: LVT) (OTC: LVTTF) (FSE: 7H7) (the "Company" or "Levitee"), an integrative wellness company with a diversified portfolio of healthcare and wellness assets, is pleased to announce the appointment of David Jenkins and Amin Lahijani to the Board. Mr. Jenkins is a global financier who works with high-net-worth individuals. He has extensive experience in public markets and has helped secure millions of dollars in capital in private and public sectors. He is a highly regarded expert in negotiating, marketing, and advertising. Mr. Jenkins has completed hundreds of multimillion-dollar deals throughout his career, demanding top price for assets in all market conditions. Mr. Jenkins brings in-depth market knowledge and experience to the company.

Mr. Lahijani has a bachelor's from the University of Simon Fraser in Kinesiology. Mr. Lahijani has worked for multiple years as a kinesiologist specializing in injuries and recovery specifically focusing on the lower lumbar. Recently Mr. Lahijani has ventured into entrepreneurship. Mr. Lahijani Holding executive roles for 15 years with a variety of businesses with significant revenues.

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Awakn Life Sciences Signs MOU with Maps

Awakn Life Sciences Signs MOU with Maps

Agreement to Explore a Partnership for MDMA-Assisted Therapy for Treatment of Alcohol Use Disorder in Europe

Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ('Awakn'), a biotechnology company developing and delivering psychedelic therapeutics (medicines and therapies) to treat Addiction, announced today it has signed a Memorandum of Understanding ("MOU") with the Multidisciplinary Association for Psychedelic Studies (MAPS) to explore a partnership to utilize MDMA-assisted therapy to treat Alcohol Use Disorder (AUD) in Europe.

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Two thirds of physicians surveyed believe psilocybin therapy has potential benefit for patients with treatment-resistant depression

London, UK and New York, US, 19 January 2022

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, and Sermo, a global leader in physician insights, today announced findings from a survey of Sermo physician members that showed two thirds (66%) of doctors surveyed believe psilocybin therapy has potential therapeutic benefit for patients with treatment-resistant depression (TRD).

More than 320 million people globally suffer with major depressive disorder (MDD) i the leading cause of disability worldwide and one of the fastest growing mental health illnesses ii . About a third of these patients 100 million people aren't helped by existing therapies and suffer with TRD iii .

Psilocybin therapy is an approach being investigated for the treatment of mental health challenges, including TRD. It combines the pharmacological effects of a synthesised version of psilocybin, a psychoactive substance that is an active ingredient in some species of mushrooms, with psychological support iv .

The survey of 259 Sermo member physicians, sponsored by COMPASS, was conducted in November 2021 and completed by participants from the US, the UK, France, Italy, Denmark, Spain and the Netherlands. Doctors were asked their views on the future of psychiatric therapy and the potential role of psilocybin therapy.

Key survey findings:

  • 66% of doctors surveyed believe psilocybin therapy has potential benefit for patients with TRD
  • 50% would prescribe psilocybin therapy, if it was approved; 32% are undecided
  • The greatest potential advantages to psilocybin treatment are believed to be: improved efficacy in treatment-resistant conditions (30%), rapid onset of action (26%), and different mechanism of action from existing therapies (19%)
  • The greatest potential barriers to treatment were cited as: needing a dedicated space for six to eight hours (28%), lack of trained therapists in a new model of psychological support (21%), and office infrastructure (15%)
  • Opinions on the optimal setting for psilocybin administration varied by region: 50% of European respondents said hospital; 42% of US respondents said specialised network of centres
  • Physicians also noted the need to educate healthcare professionals on the potential benefits of psilocybin therapy and on how to incorporate the therapy into their practice, if approved

"Severe mental illnesses, such as treatment-resistant depression, have affected too many people in society for too long. Physicians are looking for new approaches to accelerate the healing process, particularly for patients for whom current therapies have failed," said Murali Doraiswamy MBBS, FRCP, Professor of Psychiatry and Behavioural Sciences at Duke University School of Medicine, and an advisor to Sermo.

Dr Guy Goodwin, Chief Medical Officer, COMPASS Pathways, said: "These findings underline the fact that physicians need more options in helping patients suffering with treatment-resistant depression. COMPASS is developing COMP360 psilocybin therapy through a rigorous programme of research in the hope that we can offer just such an option. It's very encouraging to see that so many doctors see the potential that psilocybin could have and these insights will help us to understand how to introduce COMP360 psilocybin, with psychological support, into medical systems, if approved."

-Ends-

Survey methodology

The survey was designed to assess attitudes towards the use of psilocybin therapy in general, in psychiatry. The survey was conducted online via Sermo's RealTime platform and the random sample of physicians received compensation for their time and expertise. Survey limitations include sampling bias, inability to deduce causality from opinion polls, confounding variables not measured, and other factors.

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 have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p 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.


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 psilocybin therapy, including COMP360, as a treatment for depression, COMPASS's business strategy and goals, including its ability to launch and commercialise products, COMPASS's expectations for the timing of its pivotal phase III programme and the potential for that or other trials to support regulatory filings and approvals, COMPASS's ability to continue to advance its research or develop plans to bring its product candidates to patients, including COMP360, clinicians' perceptions of the potential advantages and efficacy of COMP360 in relation to other available therapies, including any new therapies that may be approved for the indications we are investigating, and COMPASS's expectations regarding the benefits of psilocybin therapy and the effectiveness of its executive team. 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.

About Sermo

Sermo turns physician experience, expertise, and observations into actionable insights for the global healthcare community. Engaging with more than 1.3 million HCPs across 150 countries, the company provides physicians with a social platform and unique community that fosters impactful peer-to-peer collaboration & discussions about issues that are important to them and their patients. Sermo offers on demand access to physicians via a suite of proprietary technology to provide business intelligence that benefits pharmaceutical, healthcare partners, and the medical community at large. To learn more, visit www.sermo.com .


Enquiries

Media: Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324


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Levitee Labs Announces Non-Brokered Private Placement of up to $3,000,000

Levitee Labs Announces Non-Brokered Private Placement of up to $3,000,000

  • Offering is priced at $0.20 per offered unit, with a full warrant at $0.40 for 24 months
  • Proceeds to be used for organic and inorganic growth initiatives and refocusing the company on clinical healthcare with a focus on addiction services

Levitee Labs Inc. (CSE: LVT) (OTC: LVTTF) (FSE: 7H7) (the " Company " or " Levitee "), an integrative wellness company with a diversified portfolio of healthcare and wellness assets, is pleased to announce that it is proposing to complete a non-brokered private placement (the " Private Placement ") of up to 15,000,000 units (the " Units ") at a price of $0.20 per Unit for aggregate gross proceeds of up to CAD$3,000,000. The Private Placement is subject to approval from the Canadian Securities Exchange.

Each Offered Unit will be composed of one common share of the Corporation (a " Unit Share ") and one common share purchase warrant (each whole warrant, a " Warrant "). Each Warrant will be exercisable at $0.40 per share for a period of 24 months from the date of issuance. The Company will pay a finder's fee of 8% on the gross proceeds of the Private Placement from subscribers introduced by certain finders, and will issue such number of finder's warrants (" Finder's Warrants ") as is equal to 8% of the Units sold to subscribers introduced by certain finders. Each Finder's Warrant will entitle the holder thereof to purchase one common share of the Company (a " Finder's Warrant Share ") at a price of $0.40 per Finder's Warrant Share for a period of twenty-four (24) months from the date of issuance. All securities issued under the Private Placement will be subject to a four month and one day hold period. The Offered Units are expected to be eligible for registered accounts.

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Awakn Responds to OTC Markets Request on Recent Promotional Activity

Awakn Responds to OTC Markets Request on Recent Promotional Activity

Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ("Awakn"), a biotechnology company developing and delivering psychedelic therapeutics (medicines and therapies) to treat addiction, announces that it has been requested by OTC Markets Group Inc. ("OTC Markets") to issue this statement about certain promotional activity concerning its common stock.

On Wednesday, January 12, 2022, OTC Markets informed the Company that it became aware of certain promotional activities concerning the Company and its common stock traded on the OTCQB Marketplace, specifically the distribution of promotional emails on January 12, 2022, by third-parties discussing the growing ketamine revolution, citing the Company's potential growth in the space. Upon review, the Company determined that a third party, which was not engaged by the Company or any of its officers, directors, controlling shareholders or any third-party service providers distributed promotional emails. The Company had no editorial oversight of the promotional material or any opportunity to review in advance of the distribution; however, the Company has subsequently reviewed the specific details related to the Company that were included in such promotional emails, and has confirmed these details to be factual. The Company wishes to caution readers that the statements made in such promotional emails are speculative in nature. For more complete and specific information regarding the Company, its prospects and the risks associated with those prospects, readers should review the Company's public filings on SEDAR, its website and other reliable sources. The Company encourages investors to contact their investment advisors prior to making any investment.

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