- Bucillamine is an oral drug with anti-inflammatory and antiviral properties in patients with mild to moderate COVID-19
- The company has unblinded the pre-dose selection data to potentially support the amended study protocol
- The statistician team is currently analyzing the data and the company aims to submit the amended study protocol to the FDA shortly
- Revive Therapeutics Ltd. (RVV) was down 5.75 per cent trading at C$0.41 as of 1:45 pm EDT
Revive Therapeutics (RVV) has provided an update on the company’s U.S. Food & Drug Administration (FDA) Phase 3 clinical trial.
The trial is to evaluate the safety and efficacy of Bucillamine – an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19.
The company has unblinded the pre-dose selection data to potentially support the amended Study protocol with the new primary efficacy endpoints.
The assigned unblinded statistician team is currently analyzing the data and the company aims to submit the amended study protocol to the FDA shortly thereafter.
The proposed new primary efficacy endpoints may include the rate of sustained clinical resolution of symptoms of COVID-19, which addresses the shift in COVID-19 clinical outcomes observed throughout the pandemic.
The company says this will allow it to have more meaningful study endpoints for the FDA to consider for potential Emergency Use Authorization.
According to Revive, it believes with the Omicron variant – including the BA.2 variant being the dominant strain over the Delta variant – that there is an urgent need to treat symptom resolutions in addition to preventing hospitalizations.
The company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.
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) was down 5.75 per cent trading at C$0.41 as of 1:45 pm EDT.