Revive Therapeutics (RVV.C) provides update on psychedelic development and clinical programs

Revive Therapeutics (RVV.C) provided an update on their psychedelics development and clinical programs focused on psilocybin, which they are aiming to use to treat a number of disorders.

Revive is developing a treatment for Methamphetamine Use Disorder (MUD), and is working with the Board of Regents at the University of Wisconsin System. Under the clinical trial agreement, UW will conduct Phase I & II clinical study to evaluate the safety and feasibility of using psilocybin to treat MUD. The University of Wisconsin-Madison, School of Medicine and Public Health and School of Pharmacy holds a special authorization and DEA license which allows them to perform clinical research with psilocybin, so Revive will be partnering with the university in order to get proprietary information which they hope will assist them in future FDA studies.

Under their collaboration agreement with North Carolina State University, Revive is working to develop a novel biosynthetic version of psilocybin, which will be based on a natural biosynthesis enzymatic platform developed by NC State researcher Dr. Gavin Williams. The biosynthetic platform could provide a simple and efficient method for rapidly producing psilocybin using an engineered enzymatic pathway in E. coli.

“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 intellectual property and entering into FDA clinical studies with psilocybin,” commented Michael Frank, CEO of Revive Therapeutics.

Revive is also working with LTS Lohmann Therapie-Systeme AG to develop and manufacture a proprietary psilocybin oral thin film strip. The strip would be used to fight mental illness, substance abuse, and neurological disorders, and research-grade prototypes will be available for clinical evaluations in 2022.

Revive is also advancing research intellectual property acquired from PharmaTher Holdings (PHRM.C) on using psilocybin for the management of traumatic brain injury (TBI) and strokes. Preclinical trials showed psilocybin given after an injury improved cognitive function in mice with TBI, and Revive expects to begin patient recruitment in Q4 of 2021 for their study at the University of Wisconsin-Madison.

Lastly, RVV gave an update on their international research and commercialization. They recently entered into an agreement with the University of Health Sciences Antigua (UHSA), which will see UHSA use Revive’s novel psychedelic-assisted therapies, including its tannin-chitosan delivery system, to pioneer the clinical research and development of psychedelics in Antigua and Barbuda. The partnership will lead to the establishment of a Master’s in Psychedelic Medicine for Doctor of Medicine students at UHSA, and eventually Revive hopes that this will provide a foundation for further novel psychedelic therapy research and commercial use in Antigua and Barbuda.