It’s been a long and arduous road for Revive Therapeutics Ltd. (OTC:RVVTF) regarding their Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine to treat COVID-19. The trial—fraught by several milestone misses and enrollment delays—could potentially receive a material boost after Revive submitted a request to the U.S. Food and Drug Administration (FDA) to determine and agree on reorganizing the current study’s primary efficacy endpoints to a “symptoms” focus versus the current benchmark measuring a reduction of death and hospitalizations. If successful, the trial would undergo a major de-risking event, as clinical outcomes observed over the course of the pandemic have shifted.
The announcement by Revive Therapeutics, disseminated on May 16, reaffirmed what many observers had expected following a changed primary endpoint of Adamis Pharmaceutical’s (NASDAQ:ADMP) Tempol trial from a hospitalization to symptoms focus. The company confirmed that it “has submitted a request” to “determine and agree” on potential new primary efficacy endpoints with the FDA. Furthermore, Revive reaffirmed that following the expectations of “obtain(ing) FDA agreement on the potential new primary efficacy endpoints in June 2022”, it will also meet with the study’s Data Safety and Monitoring Board shortly thereafter to determine next steps.
