Biotech
Tuesday, April 2nd, 2024 3:40 pm EDT
Key Points
- Revive Therapeutics Ltd. provides an update on its clinical study evaluating the safety and feasibility of oral psilocybin as a potential treatment for methamphetamine use disorder.
- The study has enrolled nearly 50% of its intended sample, with initial efficacy results showing promise. The clinical data may provide valuable information on safety, efficacy, and dosing of oral psilocybin, supporting potential pivotal clinical studies and commercial initiatives.
- Psilocybin-assisted psychotherapy is emerging as a promising treatment for substance use disorders, including methamphetamine use disorder, for which there are currently no approved medications. Revive Therapeutics is focusing on drug development efforts for various conditions, including infectious diseases, medical countermeasures, and rare disorders.
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 medical needs and rare disorders, is pleased to provide an update on the Company’s clinical study (the “Study”) (NCT05322954) evaluating the safety and feasibility of oral psilocybin as a potential treatment for methamphetamine use disorder conducted under an investigator-initiated IND at the University of Wisconsin-Madison, School of Medicine and Public Health and School of Pharmacy.
The Study has enrolled nearly 50% of its intended study sample, with initial efficacy being encouraging. The clinical data generated from the Study may provide proprietary and valuable information on the safety, efficacy and dosing of oral psilocybin to support a potential pivotal clinical study and commercial initiatives in countries, such as Australia, where psilocybin can be available to licensed psychiatrists to prescribe for certain conditions. In addition, the Company will have exclusive access to key intellectual property from this Study to support commercial and development initiatives, including future clinical studies for its proposed novel delivery of psilocybin by a proprietary microneedle patch under its research collaboration agreement with PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) for neuropsychiatric disorders.
Methamphetamine use disorder is a chronic relapsing condition associated with substantial mental, physical, and social harms and increasing rates of mortality. Contingency management and psychotherapy interventions are the mainstays of treatment but are modestly effective with high relapse rates, while pharmacological treatments have shown little to no efficacy. At present, there are no approved medications to treat methamphetamine use disorder. Psilocybin-assisted psychotherapy is emerging as a promising treatment for a range of difficult-to-treat conditions, including substance use disorders; however, no studies have yet been published looking at psilocybin-assisted psychotherapy in the treatment of methamphetamine use disorder.1
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 Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com
