- Revive Therapeutics (RVV) has announced an update on the Phase 3 clinical trial of Bucillamine for mild to moderate COVID-19 patients
- The FDA recommended a primary symptom-based endpoint for the trial, but the company has decided to remain with the current protocol to preserve the integrity of the study and potential future regulatory approval
- The trial’s primary endpoint is the proportion of patients meeting a composite endpoint of hospitalization or death from time of first dose through day 28 following randomization
- The company plans to continue discussions with the FDA on a pathway for potential regulatory approval and to pursue opportunities for reformulation and strategic partnerships
- Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders
- Revive Therapeutics (RVV) is currently trading at $0.055 per share
Revive Therapeutics (RVV) has announced an update on its FDA Phase 3 clinical trial for Bucillamine.
Bucillamine is an oral drug with anti-inflammatory and antiviral properties with potential benefits for mild to moderate COVID-19.
The FDA recommended a primary symptom-based endpoint, but after review and analysis, the company decided to remain with the current protocol’s primary endpoint of hospitalization or death from the time of first dose through day 28 following randomization.
The company’s advisors and clinical team concluded that any deviation from the original primary endpoint and any unblinding of post-dose selection data of approximately 500 subjects that were randomized in the current study would jeopardize any chance of potential future regulatory approval.
The company plans to continue discussions with the FDA on a pathway for future potential regulatory approval and work with current and potential new clinical sites to develop a recruitment plan that prioritizes subjects recognized to be at higher risk for developing severe COVID-19.
Revive will determine potential opportunities for unblinding additional data related to the study for evaluation to support future discussions with the FDA and further studies for long COVID or COVID symptom-related conditions, as well as various infectious and respiratory disorders.
The company also intends to develop reformulation strategies for Bucillamine to expand on its potential therapeutic utility targeting rare disorders that may come with regulatory incentives awarded by the FDA, such as orphan drug, fast track, and breakthrough therapy designations.
It should be noted that 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.
The update comes after the Data Safety Monitoring Board reviewed the study’s post-dose selection data and supported the continuation of the study, as there were no serious adverse events or safety concerns reported.
Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders.
Revive Therapeutics (RVV) is currently trading at $0.055 per share.