Revive provides update on FDA Type C meeting for study of Bucillamine

Revive Therapeutics announced today an update on the Type C meeting written responses received by the Company from the U.S. Food & Drug Administration, FDA, for the evaluation of a proposed clinical study of Bucillamine, an oral thiol-based drug with anti-inflammatory and antiviral properties, as a potential treatment for Long COVID. The FDA has recommended that the evaluation of Bucillamine for Long COVID be submitted as a new Investigational New Drug application and may cross-reference applicable sections from the Company’s current IND that evaluated the safety and efficacy of Bucillamine in patients with mild to moderate COVID-19 in a Phase 3 clinical trial. In addition, the FDA provided valuable feedback on the appropriate design, study population, and safety and efficacy measures for assessing a therapeutic benefit in patients with Long COVID. “We are pleased with the FDA’s recommendations for our proposed clinical study, which provides a pathway for the clinical development of Bucillamine as a potential treatment for Long COVID,” said Michael Frank, CEO of Revive. “We aim to finalize the clinical study protocol and submit a new IND, which will cross reference our current IND to obtain FDA approval to proceed with the clinical trial for Long COVID.”