Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF) said the results of its Phase 3 clinical trial evaluating the safety and efficacy of oral Bucillamine in patients with mild to moderate COVID-19 showed no statistical significance on the clinical endpoints.
The study enrolled 713 patients with mild-to-moderate COVID-19. There were no deaths and four hospitalizations, of which three were from the placebo arm and one from the Bucillamine low dose group of 300mg/day. No hospitalizations occurred in the Bucillamine large dose group of 600mg/day. Although the number of hospitalization events was small, it demonstrated a positive trend in the post-dose selection phase of the study. As such, given the very low probability of the study’s success and the shift in COVID-19 clinical outcomes observed throughout the pandemic, the Data Safety Monitoring Board recommended that the study be halted as announced on May 12, 2023.
The company said it evaluated additional study endpoints and there was no significant overall improvement trend between the Bucillamine and placebo arms for observed clinical symptoms and viral load data. Still, based on preliminary analyses, the data showed that for patients with oxygen saturation below 96% at baseline, Bucillamine had a 29.1% improvement over placebo in time to normal oxygen saturation.
The company said it is committed to advancing the clinical and commercial development of Bucillamine. One objective is to reformulate Bucillamine in an intravenous and inhaled version to expand on its potential therapeutic utility targeting rare disorders such as ischemia-reperfusion injury, acute respiratory distress syndrome, and potential medical countermeasures. Another objective is to work with interested pharmaceutical partners to pursue potential regulatory approvals and new clinical studies for infectious, inflammatory and respiratory disorders. The last objective is to seek out potential funding opportunities.
“The company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 at this time. There can be no assurance that the company will proceed with the clinical development and regulatory approvals of Bucillamine for COVID-19 in the US and internationally,” it said.
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.
Contact the author at jon.hopkins@proactiveinvestors.com