Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF) said it has filed an amended protocol to the US Food & Drug Administration (FDA) for the company's Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, for the treatment of patients with mild to moderate coronavirus (COVID-19).
The company said the revised protocol addresses a new primary efficacy endpoint, specifically, the time to recovery from COVID-19 via the polymerase chain reaction (PCR) test and secondary endpoints, including evaluating time to clinical improvement, comparing the frequency of hospitalization or death, and disease course in patients with mild-moderate COVID-19 receiving Bucillamine therapy with those receiving placebo.
“These proposed endpoints address the shift in COVID-19 clinical outcomes observed over the course of the pandemic, and, therefore, may have more meaningful study endpoints for the FDA to consider for regulatory approval,” it added.
READ: Revive Therapeutics says to amend study protocol for Bucillamine trial for resubmission to US FDA
Revive said if the FDA accepts the amended protocol, the Data Safety Monitoring Board will review the completed post-dose selection data under the new protocol primary efficacy endpoint and may make a recommendation on continuing or halting the trial early due to positive efficacy showing statistical significance. When this happens, the company will seek regulatory approval by the FDA and other international health regulatory agencies.
The company warned that it is not making any express or implied claims that Bucillamine has the ability to eliminate or cure COVID-19 at this time.
Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and 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. Its 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