Revive Therapeutics on track to meet planned patient enrollment for its Phase 3 Bucillamine coronavirus trial in second quarter

Revive Therapeutics Ltd (CSE:RVV) (OTCMKTS:RVVTF) (FRA:31R) told investors it was on track to meet its planned goal of enrolling up to 1,000 patients in its Phase 3 clinical trial for Bucillamine in coronavirus (COVID-19) in the second quarter this year.  The life sciences company is currently partnered with 14 clinical sites in six US states including California, Florida, Illinois, Nevada, North Carolina and Texas.  READ: Revive Therapeutics announces positive results in pre-clinical study of psilocybin to treat mild traumatic brain injury in mice And it is now expanding that to up to 50 clinical sites to include coronavirus (COVID-19) 'hot spot' states such as Massachusetts, Michigan, New Jersey, New York, Pennsylvania, and South Carolina. This Phase 3 confirmatory clinical trial will study Bucillamine in patients with mild to moderate COVID-19 and will enroll up to 1,000 patients who will be randomized to Bucillamine or a placebo for up to 14 days. The main aim is to compare the frequency of hospitalization or death for those receiving Bucillamine therapy with those receiving placebo. Safety and efficacy data at each interim analysis timepoint at 210, 400, 600 and 800 completed patients are only made available to the Data and Safety Monitoring Board (DSMB) for review and recommendations on continuation, stopping or changes to the study. In today's statement, Revive noted that so far, there had been no serious adverse events or safety concerns that required the Independent to be notified or take action. It also noted that it had recently approached the Food and Drug Administration (FDA) on a potential filing of an Emergency Use Authorization (EUA) application, while the trial is ongoing, so as to receive this approval before the study is completed. "We are making good progress both on enrollment and expansion of clinical sites in hot spot areas in the U.S. and we are positioned well to explore strategic initiatives in completing the Phase 3 study, as well as seeking a path forward for EUA approval from the FDA," said Michael Frank, the CEO of Revive. Revive is focused on the research and development of therapeutics for infectious diseases and rare disorders. Contact the author at giles@proactiveinvestors.com