Revive Therapeutics Ltd (CSE:RVV) (OTCMKTS:RVVTF) said Monday it is expanding its psychedelic therapeutic product pipeline focusing on its oral thin-film delivery system while advancing its clinical study to evaluate the safety and feasibility of psilocybin in adults with methamphetamine use disorder.
The Toronto-based firm recently received the first set of orally dissolvable thin film strips that will deliver psilocybin and, further down the line, psychedelic-derived medicine to help treat various conditions.
Revive also is working with Reed Research Group out of the University of Wisconsin-Madison to evaluate novel formulations of psilocybin.
READ: Revive Therapeutics lead drug Bucillamine approved for compassionate use in treatment of COVID-19 patients
“We are expanding our product pipeline with a focus on psychedelic therapeutics incorporating our novel oral thin-film delivery technology with psilocybin, in which we have prototypes developed and we will move towards clinical studies with the University of Wisconsin-Madison along with other key industry partners,” said CEO Michael Frank in a statement providing shareholders with a corporate update.
“In addition, we are advancing our Phase I clinical study to evaluate the safety and feasibility of psilocybin in adults with methamphetamine use disorder. Our initiatives in product development and clinical studies gives us a leading position in the psychedelic space.”
Psilocybin oral thin-film product
Under its sponsored research partnership with the Reed Research Group out of the university, Revive is developing its tannin-chitosan composite of orally dissolvable thin films, which offers a unique delivery platform for therapeutic doses from one to 20 milligrams of psilocybin into the oral cavity.
The company has received its final set of prototypes and is preparing to scale for manufacturing for future clinical studies involving psilocybin and other psychedelic-derived medicines.
Revive said there are a number of advantages and benefits of an orally dissolvable psilocybin thin film, including the rapid dissolving and onset of action to the bloodstream; the ease and convenience for patients to administer without the need of water, chewing or swallowing; the potential of improved therapeutic outcomes, and efficacy for underserved diseases and disorders including the flexibility to create accurate dosing and tasteful options.
The company’s delivery technology is a natural, non-toxic, biodegradable, and biocompatible composite that combines a tannin material, which is derived from a plant group having antibacterial, antifungal, antioxidant and wound healing properties, and a chitosan material, which is derived from the crustacean group having blood-clotting and antimicrobial properties. The delivery technology has a rapid onset of action and controlled or sustained release potential capabilities and may allow combining multiple extracts from mushrooms in one formulation.
Clinical study of psilocybin
Revive recently announced that it has entered into a Clinical Trial Agreement with the Board of Regents of the University of Wisconsin System to conduct a clinical study entitled “Phase I Study of the Safety and Feasibility of Psilocybin in Adults with Methamphetamine Use Disorder.”
The Phase I study Principal Investigator is Christopher Nicholas, assistant professor of program for research outreach therapeutics and education in the addictions in the Department of Family Medicine and Community Health at University of Wisconsin School of Medicine and Public Health.
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 US Drug Enforcement Agency license to perform clinical research with psilocybin. The company said it will have exclusive access to key intellectual property from this study.
Contact the author: [email protected]
Follow him on Twitter @PatrickMGraham