- Revive Therapeutics (RVV) has provided an update on the company’s U.S. Food & Drug Administration (FDA) Phase 3 clinical trial
- Revive will amend the study protocol with new primary efficacy endpoints and submit it to the FDA
- The new endpoints address the shift in COVID-19 clinical outcomes throughout the pandemic and provide more meaningful endpoints for the FDA to consider
- Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders
- Revive Therapeutics Ltd. (RVV) is up 9.3 per cent on the day, trading at C$0.47 per share at 10:15 am ET
Revive Therapeutics (RVV) has provided an update on the company’s U.S. Food & Drug Administration (FDA) Phase 3 clinical trial.
The trial evaluates the safety and efficacy of Bucillamine – an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19.
After a lengthy analysis of the supporting pre-dose selection data from the study, Revive will now amend the study protocol with the proposed new primary efficacy endpoints and submit to the FDA for further discussion and agreement.
The proposed new primary efficacy endpoints may include the time to resolution from COVID-19 via the polymerase chain reaction (PCR) test and the rate of sustained clinical resolution of specific symptoms of COVID-19.
The company says that the proposed endpoints address the shift in COVID-19 clinical outcomes observed throughout the pandemic and, therefore, have more meaningful study endpoints for the FDA to consider for regulatory approval.
The company believes that with the Omicron variant, including the spreading of BA.5, currently the dominant strain, there is an urgent need to treat symptom resolutions in addition to preventing hospitalizations.
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.
With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of psilocybin-based therapeutics in various diseases and disorders.
Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases. The company was granted an FDA orphan drug status designation for cannabidiol (CBD) to treat autoimmune hepatitis (liver disease), ischemia, and reperfusion injury from organ transplantation.
Revive Therapeutics Ltd. (RVV) is up 9.3 per cent on the day, trading at C$0.47 per share at 10:15 am ET.