Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF) said it has enrolled the first patient in its phase I/II clinical study (NCT05322954) evaluating the safety and feasibility of oral psilocybin as a potential treatment for methamphetamine use disorder.
The investigator-initiated IND (investigational new drug), led by Dr. Christopher Nicholas, is being conducted at the University of Wisconsin-Madison, School of Medicine and Public Health and School of Pharmacy.
Initial results from the study are expected in the third quarter of 2023.
“We are committed to advancing novel uses and delivery forms of psilocybin to treat substance abuse and mental health disorders,” said Michael Frank, CEO of Revive in a statement.
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“The clinical trial evaluating oral psilocybin for methamphetamine use disorder is a study to potentially demonstrate psilocybin’s utility for substance abuse indications and support future commercial and clinical studies using our oral thin film strip and transdermal microneedle patch delivery technologies,” he added.
Revive said the clinical data generated from the study may provide proprietary and valuable information on the safety, efficacy and dosing of oral psilocybin to support potential research and commercial initiatives in countries, such as Australia, where psilocybin can be available to specially-licensed psychiatrists to prescribe for certain conditions and future clinical studies for the company’s proposed psilocybin oral thin film strip and transdermal microneedle patch products.
In addition, the company will have exclusive access to key intellectual property from the study to support development, regulatory and commercial initiatives.
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 these 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, Revive noted.
Revive Therapeutics is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the Food and Drug Administration (FDA) such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations.
Currently, the company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders.
Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation.
Contact the author at jon.hopkins@proactiveinvestors.com