Psilocybin

GREENWICH, Conn. , Oct. 31, 2024 /PRNewswire/ -- B.More Inc., a 501(c)(3) non-profit, clinical-stage biopharmaceutical company dedicated to the development of psychedelic medicines for substance abuse disorders, is pleased to announce that its collaborator, Dr. Michael Bogenschutz, Director of the NYU Langone Center for Psychedelic Medicine, has been awarded a grant of $3 million per year for a total of 5 years dependent on progress during the first 2 years, from the National Institute of Drug Abuse (NIDA). This funding will support the first clinical trial to evaluate psilocybin's efficacy as a treatment for Opioid Use Disorder (OUD). If successful, the trial will provide the basis for a full-scale drug development program aimed at achieving FDA approval for psilocybin as a treatment for OUD. The NIDA-funded, double-blind, multi-site, phase 2 randomized controlled clinical trial will assess psilocybin's therapeutic potential to reduce opioid cravings and improve emotional well-being in individuals struggling with OUD but who continue to use non-prescribed opioids despite adherence to methadone treatment. Conducted across four treatment centers in New York and New Mexico, the trial plans to enroll 240 participants, including OUD patients with co-occurring substance use and psychiatric disorders. With participants drawn predominantly from low-income minority populations, the study marks a significant shift toward diversity in psychedelic research, addressing a critical knowledge gap with respect to underrepresented groups. Participants will receive manualized, non-directive clinical support and will be randomly assigned to receive a single administration of psilocybin 30 mg (high dose), psilocybin 20 mg (medium dose), or psilocybin 1 mg (low-dose control condition). Weekly urine drug screens and continuous self-report of opioid and other drug use will be collected for 24 weeks after psilocybin administration, along with measures probing OUD-related neuropsychopathology and functional outcomes. Unlike previously reported psychedelic trials, the study will include prospective assessment of pre-randomized patient expectancies along with post-treatment patient beliefs regarding treatment assignment, providing data for modelling the contribution of expectancy effects on reported outcomes. B.More, which will license the trial data for commercial development, will supply cGMP psilocybin for the study and will also fund other support for the goal of an eventual New Drug Application (NDA). "This trial is a vital step toward understanding psilocybin's therapeutic potential in Opioid Use Disorder," said Carey Turnbull, Co-founder, and CEO of B.More Inc. "In working with Dr. Bogenschutz, our goal is to create a treatment pathway that's accessible, effective, and safe, opening new avenues for psychedelic-assisted therapy as an FDA-approved tool in the fight against addiction. This NIDA funded OUD trial taking place in substance abuse treatment centers pairs nicely with NYU's previously announced NIH funded alcohol use disorder trial being conducted within the Silver Hill rehab center, adding to their expertise in the treatment of substance abuse using psilocybin." According to Dr. Bogenschutz, "In addition to providing a rigorous test of safety and efficacy, this trial will provide information regarding the feasibility of implementing psilocybin-assisted treatment for OUD within the existing system of care. If psilocybin is found to be safe and effective, this model would provide a new option for OUD patients who are receiving treatment but continue to struggle with illicit opioid use." About B.More Founded in 2017 by Carey and Claudia Turnbull, B.More is a 501(c)(3) non-profit, clinical-stage biopharmaceutical company with a mission to develop better treatment options for those struggling with alcohol use disorder and other substance use disorders. With researchers at the NYU Grossman School of Medicine, B.More is advancing clinical research to help these individuals, and their loved ones, live a better tomorrow. For more information, please visit Logo - SOURCE B.More Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

TORONTO, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for infectious diseases and medical countermeasures, announced today an update on the research study evaluating Bucillamine as a potential treatment for nerve agent exposure, in partnership with Defence R&D Canada – Suffield Research Centre (“DRDC”), an agency of the Canadian Department of National Defence. The DRDC is investigating pharmacological compounds, including Bucillamine, that can mitigate nerve agent induced brain injury. The DRDC conducted an additional control study to achieve optimal dosing. The research study is progressing and is now expected to be completed with final results by the end of calendar 2024. The results from this research study, if promising, will determine further studies to facilitate FDA and Health Canada approvals for the use of Bucillamine in nerve agents or organophosphate pesticide poisoning and explore its potential for traumatic brain injury caused by concussive or explosive forces and viral infections. Nerve agents are chemicals that affect the nervous system. Nerve agents are highly toxic regardless of the route of exposure. The main chemical nerve agents that are man-made and manufactured for use in chemical warfare are sarin, soman, tabun and VX. These nerve agents are known to be present in military stockpiles. Exposure to nerve agents can occur due to chemical warfare or accidental release from a military storage facility. Exposure to nerve agents can cause tightness of the chest, excessive salivation, abdominal cramps, diarrhea, blurred vision, tremors, and death. Recent studies have shown that antioxidant compounds such as n-acetylcysteine (“NAC”) could be beneficial in limiting seizure activity and improving the anticonvulsant efficacy of GABA-mediating drugs such as diazepam. Bucillamine is a significantly more effective antioxidant than NAC and has the potential to provide increased efficacy against seizure activity while limiting the anticoagulant and bleeding event liability observed with NAC. The overall objective of the research project is to investigate pharmacological means for neuroprotection of GABA(A) receptors, which are required for the effectiveness of currently fielded anticonvulsant therapies. Bucillamine and NAC will be evaluated to determine the effect on GABA(A) receptor endocytosis and the effect on diazepam effectiveness in terminating seizures. Any additional antioxidant effects on seizure activity and survival will also be assessed. About Revive Therapeutics Ltd. Revive Therapeutics is a life sciences company focused on the research and development of therapeutics and diagnostics for infectious diseases, medical countermeasures, and rare disorders. Revive prioritizes its drug development efforts to take advantage of several regulatory incentives awarded by the FDA, such as Emergency Use Authorization, Orphan Drug, Fast Track, and Breakthrough Therapy designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of nerve agent exposure and long COVID. Revive is also advancing the development of Psilocybin-based therapeutics through various programs. For more information, visit www.ReviveThera.com. For more information, please contact: Michael FrankChief Executive OfficerRevive Therapeutics Ltd.Tel: 1 888 901 0036Email: mfrank@revivethera.comWebsite: www.revivethera.com Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts responsibility for the adequacy or accuracy of this release. Cautionary Statement This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “may”, “could”, “intend”, “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 Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company's management's discussion and analysis for the year ended June 30, 2024 ("MD&A"), dated October 25, 2024, which is available on the Company's profile at www.sedarplus.ca.