Revive Therapeutics (RVV.C) provided an update on their psilocybin development programs today.
“Revive is building a specialty psilocybin-based product pipeline to treat mental illness, substance abuse and neurological disorders. We are embarking on our first clinical study evaluating psilocybin in the treatment of methamphetamine use disorder and advancing the development of an oral psilocybin thin file strip and psilocybin microneedle patch, which will offer flexible therapeutic solutions of psilocybin for unmet medical needs,” according to Michael Frank, chief executive officer.
Before we get started on the update:
Revive is a life sciences company working on research and development for therapeutics for infectious diseases and other rare disorders. It’s put a priority on drug development to quality for regulatory incentives and designations offered by the FDA like Orphan Drug, Fast Track, Breakthrough Therapy, and Rare Pediatric Disease.
Here’s the update.
Psilocybin for Methamphetamine Use Disorder
Beginning our short list is Revive’s quest to evaluate psilocybin for use as a potential treatment of methamphetamine use disorder, alongside the University of Wisconsin-Madison, through a clinical trial agreement. The Phase I/II clinical study will be overseen by Doctor’s Christopher Nicholas and Paul Hutson, and performed to study the safety and feasibility of the drug for adults suffering the disorder. It also already received Institutional Review Board (IRB) approval.
Psilocybin for Stroke
Together with the University of Wisconsin-Madison, the company is looking into psilocybin as a potential treatment for stroke. The proposed Phase I/II clinical study protocol to evaluate the safety and feasibility of the drug with stroke patients is due to be submitted to the IRB by February. The study will produce clinical data to help provide proprietary and valuable information on the safety, efficacy and dosing of psilocybin to support future FDA clinical studies for their thin strip project. As a feather in their cap, it will also give them more intellectual property to draw on to support themselves in the development, regulatory and commercial aspects of the future.
Psilocybin Oral Thin Film Strip
Revive is getting into the thin-strip market. Normally used in cannabis, it’s a sublingual strip wherein the drug dissolves its way through the mouth into the lymphatic system for greater bioavailability. It’s been used in cannabis in the past to deliver CBD and other cannabinoids into the bloodstream. The company is presently under a feasibility agreement with Lohmann Therapie-Systeme AG, a leader in pharma-oral thin films, to deliver and manufacture one using psilocybin for mental illness, substance abuse and neurological disorders. The research prototype is underway to support IND-studies and they hope to conduct a full clinical by Q4, 2022.
Psilocybin Microneedle Patch
This spate of research is a collaborative effort with PharmaTher Holdings (PHRM.C) and intends to evaluate the delivery of psilocybin with PharmaTher’s microneedle path technology for neuropsychiatric disorders. The project plan has been finalized and the company is looking to initiate IND-enabling studies and get clinical trials rolling by Q4, 2022.
Revive is developing a biosynthetic version of psilocybin based on a natural biosynthesis enzymatic platform presently under collaboration with North Carolina State University and developed by Dr. Gavin Williams, who teaches and does research there. The platform provides a simple and efficient method for producing natural products, like psilocybin, using an engineered enzymatic pathway in E. Coli. Estimated completion date for a research-grade batch of psilocybin is Q2, 2022, with clinical studies to begin in 2023.
Psilocybin International Research
The company inked an agreement with the University of Health Sciences Antigua to use Revive’s psychedelic assisted therapies, including their tannin-chitosan delivery system and for clinical research and development of psychedelics in Antigua and Barbuda. Estimated start date for clinical research is 2022 with an eye towards commercialization.