- Revive Therapeutics (CSE:RVV) has received US FDA approval to move ahead with its evaluation of Bucillamine as a COVID-19 treatment
- The approval comes after a positive Pre-Investigational New Drug meeting with the regulatory body
- Revive will now proceed with a Phase 3 confirmatory clinical trial of the drug
- The FDA has also provided valuable guidance on study design regarding the trial
- Revive Therapeutics (RVV) is currently up 8.11 per cent to C$0.20 per share, with a market cap of $12.16 million
Revive Therapeutics (CSE:RVV) has received US FDA approval to move ahead with its evaluation of Bucillamine as a COVID-19 treatment.
The blessing from the Food and Drug Administration comes after a successful Pre-Investigational New Drug (pre-IND) meeting. The meeting was announced on April 3 this year.
Revive will now proceed with a Phase 3 confirmatory clinical trial to evaluate the safety and efficacy of Bucillamine.
In further support of the trial, the FDA has also offered guidance regarding study design and outcome measures.
Most importantly, the FDA agreed that Revive could rely on data from a previous IND regarding Bucillamine for gout treatment. As such, the company will not need to undertake any Phase 1 or Phase 2 clinical studies.
Revive, and its Contract Research Organisation (CRO), Pharm-Olam LLC, is now actively incorporating the FDA’s guidance in preparing a Phase 3 package for submission. The company expects to file the final IND within the next 60 days. After this, the Phase 3 trial will commence.
Michael Frank, CEO of Revive Therapeutics, said that the approval to continue studies is a sure sign of Bucillamine’s potential.
“FDA’s support in advising Revive to move directly into a Phase 3 confirmatory trial provides an acknowledgment for the potential of Bucillamine in the treatment of COVID-19.
“Entering into a Phase 3 study is a major milestone for the company. We are excited to unlock the full potential of Bucillamine, not only for this virus, but also for other infectious diseases that we will investigate in the future,” he added.
Revive Therapeutics (RVV) is currently up 8.11 per cent to C$0.20 per share at 12:18pm EST.