Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF) said its Phase 3 clinical trial evaluating Bucillamine, an oral drug with anti-inflammatory and antiviral properties in patients with mild to moderate COVID-19, has been halted.
The company said on May 10, 2023, the Data Safety Monitoring Board (DSMB) met to review the study’s post-dose selection data under its current protocol primary endpoint, the proportion of patients meeting a composite endpoint of hospitalization or death from the time of first dose through day 28 following randomization. The DSMB recommended that the study be halted early as the statistical significance of the primary endpoint unlikely to be met should the study continue toward completion.
The company said it has halted the study and will now proceed to unblind and seek an evaluation of the study data to determine the potential next clinical and regulatory steps for Bucillamine.
Revive said it believes an evaluation of the study’s data could support future discussions with the Food and Drug Administration (FDA) on potential new clinical studies and allow the opportunity to work with potential domestic and international pharmaceutical partners to determine suitable regulatory pathways for the approval of Bucillamine based on the study’s data.
Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it 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.
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