Revive Therapeutics (OTCQB:RVVTF; CSE:RVV) reported that its Phase 3 clinical study evaluating the safety and efficacy of oral Bucillamine in patients with mild- to-moderate COVID-19 did not achieve statistical significance on the clinical endpoints. The study enrolled 713 patients.
The Data Safety Monitoring Board recommended the study be halted in mid-May based on a very low probability of success and the shift in COVID-19 clinical outcomes observed throughout the pandemic, where many patients with COVID-19 were either asymptomatic or experienced mild to moderate illness and could be managed in the outpatient setting.
Based on the study’s data analyzed to date, the company is committed to advancing the clinical and commercial development of Bucillamine and is pursuing reformulating Bucillamine in an intravenous and inhaled version to expand on its potential therapeutic utility.
As a result, it plans to target rare disorders, such as ischemia-reperfusion injury, acute respiratory distress syndrome, and potential medical countermeasures, such as a terrorist attack with a biological, chemical, or radiological/nuclear material, or a naturally occurring emerging disease, that may come with regulatory incentives awarded by the FDA, such as emergency use authorization, orphan drug, fast track, and breakthrough therapy designations.
The company also plans to pursue pharmaceutical partners to conduct new clinical studies for infectious, inflammatory and respiratory disorders, as well as potential government funding opportunities.
