First subject enrolled and initial top-line results expected in Q3-2023
TORONTO, March 28, 2023 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to provide an update on the Company’s Phase I/II clinical study (the “Study”) (NCT05322954) evaluating the safety and feasibility of oral psilocybin as a potential treatment for methamphetamine use disorder conducted at the University of Wisconsin-Madison, School of Medicine and Public Health and School of Pharmacy. Under an investigator-initiated IND, led by Dr. Christopher Nicholas, PhD, the Study has enrolled its first patient and initial results are expected in Q3-2023.
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 this 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 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.1
“We are committed to advancing novel uses and delivery forms of psilocybin to treat substance abuse and mental health disorders. 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,” said Michael Frank, CEO of Revive.
About Revive Therapeutics Ltd.
Revive 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 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. For more information, visit www.ReviveThera.com.
For more information, please contact:
Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com
Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts responsibility for the adequacy or accuracy of this release.
Cautionary Statement
This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “may”, “expect”, “can”, “believe”, “will”, “projected”, “estimated”, “potential”, “expected”, “proposed”, “committed”, and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2022, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.
Source:
Revive Therapeutics Provides Update on Phase 3 Clinical Trial for Bucillamine in COVID-19
Expected to seek DSMB approval to proceed with EUA application to the FDA in Q2-2022
Revive Therapeutics Receives FDA Orphan Drug Designation for Bucillamine in the Prevention of Ischemia-Reperfusion Injury During Liver Transplantation
The ODD validates our strategy in pursuing novel uses of Bucillamine for rare disorders and life-threatening conditions, including infectious diseases and preventing IRI during other organ transplantations.
Revive Therapeutics Clarifies Status of Its Phase 3 Clinical Trial for Bucillamine in COVID-19
Expanding the potential of Bucillamine as an effective treatment for Omicron variant
UPDATE — Revive Therapeutics Expands Bucillamine Research to Treat Omicron Variant and Adds Inflammatory Markers to FDA Phase 3 Clinical Trial
Expanding the potential of Bucillamine as an effective treatment for Omicron variant