Revive Therapeutics Ltd. (CNSX: RVV )(OTCMKTS: RVVTF) has achieved an important milestone in the trajectory of its current Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine to treat COVID-19. The company announced today the intention to pursue new primary symptoms endpoints from the current benchmark of the reduction of hospitalization and death. In theory, the course of action marks a decisive turn in the trial which began nearly twenty-one months ago.
According to today’s press release, Revive Therapeutics “will now amend the Study protocol with the proposed new primary efficacy endpoints and submit to the U.S. Food & Drug Administration (FDA) for further discussion and agreement” following “a lengthy review and analysis”, which included unblinded pre-dose-selection data for the first 210 patients of the trial. The FDA’s allowance for company-affiliated statistician(s) to review unblinded data ultimately fostered the confidence needed for Revive Therapeutics to pursue a new symptoms endpoint focus.
While the news was material and de-risks the trajectory of the trial, Revive has not yet filed an endpoint change submission with the FDA. Once this takes place, the ball is with the FDA and Institutional Review Board to review and approve the company’s requested changes.
The prospective endpoint swap is the final step before a Data Safety & Monitoring Board meeting can take place to analyze the new data and for the Board to make a determination of whether to halt, continue or unblind the trial results completely—each scenario presenting its own risks and rewards to investors.
An endpoint submission is expected to take place in short order, given the importance of Bucillamine to achieve commercial success as soon as possible.
COVID Therapeutics Market Still Wide Open For Efficacious Solutions
For several weeks now, the waning efficacy of Pfizer’s antiviral medication Paxlovid—the leading oral COVID therapeutic pill on the market— has been mainstream news. Along with another surge in cases and persistent rate of infections in the general population, has provided a renewed urgency for new therapeutic options to be developed.
On June 14, a pre-print study published by MedRxiv revealed that the overall risk of hospitalization was 45% lower among patients prescribed Paxlovid, compared to the 89% reduction in hospitalizations indicated in Paxlovid’s high-risk clinical trial (Delta Wave). A full 6036 patients of the study conducted—or 19.9% of the study 30,322 non-hospitalized patients in the trial design—were prescribed Paxlovid, giving it a strong statistical backbone. The study was lead by Dr. Scott Dryden-Peterson, an infectious disease specialist with Brigham and Women’s Hospital in Boston.
Shortly thereafter, National Institute of Allergy and Infectious Diseases (NIAID) Director revealed he was experiencing a rebound of his COVID-19 infection after taking a course of Paxlovid medication. A few weeks later, U.S. president Joe Biden experienced a similar fate, forcing him into “strict isolation procedures” for several days beyond normal recommended quarantine times. Eventually, both leaders were tested, cleared of the infection and resumed normal functions.
On the immediate horizon, the only new oral COVID therapeutic drug with a clear path to market is Veru Inc. drug Sabizabulin for the treatment of hospitalized moderate to severe COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS). The company submitted an Emergency Use Authorization application to the FDA on June 7, and is currently awaiting on approval from the FDA.
The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has also informed Veru that its Sabizabulin Marketing Authorization Application will receive expedited review.
In response to the news, Revive Therapeutics closed higher by +4.17%—to $0.35 per share—on the OTC exchange.
TDR will provide additional coverage as Revive Therapeutics works its way through the endpoint submission process.