Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF) has said it will amend the study protocol for the Phase 3 clinical trial evaluating the safety and efficacy of Bucillamine in patients with mild to moderate COVID-19 with new primary efficacy endpoints for resubmission to the US Food & Drug Administration (FDA) for further discussion and agreement.
The life sciences company said this follows a lengthy review by the unblinded statistician team, which included analysing the supporting pre-dose selection data from the study.
The proposed new primary efficacy endpoints may include the time to resolution from COVID-19 via the polymerase chain reaction (PCR) test and the rate of sustained clinical resolution of certain symptoms of COVID-19. These proposed endpoints address the shift in COVID-19 clinical outcomes observed over the course of the pandemic, and, therefore, have more meaningful study endpoints for the FDA to consider for regulatory approval, it added.
READ: Revive Therapeutics provides update on proposed amended study protocol for its Phase 3 bucillamine for COVID-19 clinical trial
Revive said it believes that with the Omicron variant, including the spreading of the current dominant strain BA.5, there is an urgent need to treat symptom resolutions in addition to preventing hospitalizations.
The company added that it 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.
Revive is 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. It is currently exploring the use of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19.
Contact the author at jon.hopkins@proactiveinvestors.com