Revive Therapeutics provides update on Phase 3 trial for bucillamine in COVID-19

Revive Therapeutics is pleased to provide an update on the Company's U.S. Food & Drug Administration Phase 3 clinical trial 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 Company has received positive comments from the FDA in regards to the Company's request to determine and agree on the Study's potential new primary efficacy endpoints, including the rate of sustained clinical resolution of symptoms of COVID-19, which addresses the shift in COVID-19 clinical outcome observed over the course of the pandemic, and, therefore, to have more meaningful study endpoints for the FDA to consider for potential Emergency Use Authorization. The FDA has agreed that the Company may unblind the pre-dose-selection data for the first 210 patients of the Study to further support the new primary endpoint. Before unblinding the pre-dose selection data for the first 210 patients, the Company will submit a Data Access Plan to the FDA in early June 2022 with the aim to unblind the pre-dose selection data and submit the amended Study protocol with the new primary efficacy endpoints to the FDA. In addition, the Data Safety and Monitoring Board are scheduled to meet thereafter to evaluate the interim clinical and safety data and may make a recommendation on continuing the Study or advise on halting the Study early due to positive efficacy based on other clinical outcomes such as the rate of sustained clinical resolution of symptoms of COVID-19. The DSMB supported the continuation of the Study in its last meeting as there were no serious adverse events or safety concerns reported.