Revive Therapeutics Ltd. (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, announced today that the U.S. Food & Drug Administration (“FDA”) has responded that a Type C meeting would be recommended, which the Company will request, to discuss the overall development plan and the latest revised endpoints for the Company’s Phase 3 clinical trial (the “Study”) (NCT04504734) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19.
The FDA has now requested additional information, which would include clinical data, for them to agree on the Study’s revised endpoints. The Company plans to go over with the FDA the overall development plan for Bucillamine in COVID-19 and further review the Pre-Dose selection data that would support the appropriate endpoints. The Company previously submitted to the FDA the Study’s amended protocol with a new primary efficacy endpoint, specifically, assessing the difference in the proportion of participants with improvement in at least two COVID-19 related clinical symptoms on or before Day 14 compared with baseline between Bucillamine versus placebo. Additional secondary endpoints may include the time to the polymerase chain reaction resolution, clinical outcome (death or hospitalization), disease severity, supplemental oxygen use, and progression of COVID-19. Should the FDA agree with the revised protocol, the Data Safety Monitoring Board (“DSMB”) will then review the completed Post-Dose selection data of approximately 500 subjects in the context of the new primary endpoint. The DSMB may recommend continuing the Study if there is a trend toward achieving statistical significance, halting the Study early due to statistical significance likely not going to be met, or halting the Study early due to positive efficacy showing statistical significance.
The Company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time
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.