- Revive Therapeutics Ltd. (RVV) has announced an update of its Food and Drug Administration (FDA) phase three clinical trial for Bucillamine
- Bucillamine is an oral drug with anti-inflammatory and antiviral properties treating moderate COVID-19 cases
- Revive has worked to submit a revised protocol with a new primary efficacy endpoint for the drug’s study
- The company expects to submit the revised protocol sometime next week
- Revive Therapeutics Ltd. (RVV) is up 42.86 per cent and is trading at $0.30 per share as of 2:58 p.m. ET
Revive Therapeutics (RVV) announced an update of its Food and Drug Administration (FDA) phase three clinical trial for Bucillamine.
Bucillamine is an oral drug with anti-inflammatory and antiviral properties to treat moderate COVID-19 cases.
Revive is a life sciences company focused on researching and developing therapeutics for infectious diseases and rare disorders. It is prioritizing drug development efforts to take advantage of several regulatory incentives.
On top of the company’s recent submission of the study’s amended protocol, it has worked to submit a revised protocol with a new primary efficacy endpoint.
The revision would assess the difference in the proportion of participants with at least two clinical improvements in symptoms of COVID-19 at day 14 compared to the baseline between Bucillamine versus placebo.
Revive stated that additional secondary endpoints may include clinical outcome, disease severity, supplemental oxygen use, and progression of COVID-19.
The company expects to submit the revised protocol sometime next week. If the FDA agrees with the revised protocol, the Data Safety Monitoring Board (DSMB) will then review the post-dose selection data for roughly 500 subjects for a new primary endpoint.
Revive Therapeutics Ltd. (RVV) is up 42.86 per cent and is trading at $0.30 per share as of 2:58 p.m. ET.
