Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF, FRA:31R) said it is advancing to Food and Drug Administration (FDA) clinical studies with psilocybin for methamphetamine use disorder and stroke.
In a statement, Revive CEO Michael Frank said: "We are advancing a robust psychedelics-based product pipeline that includes product development, preclinical and clinical studies that aim to unlock the potential therapeutic value of psilocybin in various uses, formulations and delivery methods to treat mental health, substance abuse and neurological disorders.”
“Revive is embarking on the next stage of growth of its psychedelics strategy by focusing on building key partnerships with US academic institutions and other leading organizations, as well as developing IP and entering into FDA clinical studies with psilocybin.”
While providing an update on Revive’s psychedelics clinical programs with psilocybin, the Toronto-based life sciences company said that it is working with the Board of Regents of the University of Wisconsin System under a clinical trial agreement to conduct a Phase I/II clinical study to evaluate the safety and feasibility of psilocybin in adults with methamphetamine use disorder.
“Study start-up activities have taken place and enrollment activities are to continue throughout the remainder of the year,” said the company. As a result of the study, clinical data will provide valuable information on the safety, effectiveness, and dosing of psilocybin to support future pivotal FDA clinical studies in oral forms of delivery including oral thin film strips.
“The clinical study will be conducted at the University of Wisconsin-Madison, School of Medicine and Public Health and School of Pharmacy, which holds a Wisconsin special authorization and DEA license to perform clinical research with psilocybin,” said the company. Revive will have access to key IP from the study to support commercial initiatives.
Psilocybin aimed at Traumatic Brain Injury
Revive is advancing the research and intellectual property acquired from PharmaTher Holdings Ltd on psilocybin as a potential solution to managing Traumatic Brain Injury (TBI) and stroke. Preclinical studies demonstrated that psilocybin, given after injury, improved cognitive function in TBI mice. Revive said it is proceeding to an FDA clinical study to be conducted at the University of Wisconsin-Madison, School of Medicine and Public Health and School of Pharmacy. “Start-up activities have already begun and patient enrollment is expected to commence in 4Q 2021,” said the company.
Psilocybin oral thin-film strip development
Revive said it has initiated the product development program under a feasibility agreement with LTS Lohmann Therapie-Systeme AG, a leader in pharmaceutical oral thin films, to develop and manufacture a proprietary psilocybin oral thin-film strip for mental illness, substance abuse and neurological disorders. “Research grade prototypes will be available to evaluate dosing and delivery rates in various dosage forms with the expectation to conduct clinical studies in 2022,” said the company.
Psilocybin biosynthesis program
Under its collaboration with North Carolina State University (NC State), Revive is developing a novel biosynthetic version of psilocybin based on a natural biosynthesis enzymatic platform developed by Dr Gavin Williams, Professor and Researcher at NC State.
The biosynthetic platform developed by Dr Williams provides a potentially simple and efficient method for rapidly producing natural products, such as psilocybin, using an engineered enzymatic pathway in E. coli. “Certain technical milestones have been achieved to date, offering a clear path towards completing validation methods to demonstrate a novel yet simple production process of biosynthetic psilocybin that can be used at a critical scale for clinical and commercial use,” said the company.
Psilocybin international research
Revive has struck an agreement with the University of Health Sciences Antigua to utilize its psychedelic-assisted therapies including its tannin-chitosan delivery system and to pioneer the clinical research and development of psychedelics in Antigua and Barbuda. “Clinical research will be conducted at the University in 4Q 2021 with the aim for commercialization in 2022 in Antigua and Barbuda,” said the company.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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