Revive Therapeutics with Update on Bucillamine Tests
The company is also planning to apply for a EU emergency use authorization.

Aside from sounding like pasta, bucillamine is an anti-inflammatory drug with a known safety profile that is commonly prescribed for the treatment of rheumatoid arthritis. However, various studies led by Revive have explored other uses for bucillamine, including the treatment of gout, a complex form of arthritis. In a 2015 Phase 2a study, bucillamine demonstrated safety and effectiveness in treating gout in patients with no serious or adverse events. In addition, on July 31, 2020, Revive received FDA approval to begin a Phase 3 clinical trial to investigate the safety and efficacy of its bucillamine in the treatment of patients with mild to moderate COVID-19. With this in mind, Revive's Phase 3 clinical trial is currently underway. The company announced yesterday that it plans to meet the Data and Safety Monitoring Board (DSMB) on 600 completed patients, which is expected to take place in the third quarter of 2021. In context: The DSMB is an independent group of experts that provides its expertise and recommendations for clinical studies such as Revive's Phase 3 study. As recommended by the DSMB, Revive intends to continue its Phase 3 clinical trial at the proposed high dose of 600 mg. In addition, the company is preparing to potentially file an Emergency Use Authorization (EUA) with the FDA in the event the DSMB recommends Bucillamine for the emergency treatment of mild to moderate COVID-19. To date, Revive has partnered 40 clinical centers in fourteen different US states, and the company plans to increase that number to 50. In addition, Revive is in discussions with well-known international pharmaceutical companies who wish to acquire the commercial rights to Revive's Bucillamine treatment for COVID-19 in Europe, India and Asia. With this in mind, Revive is pursuing a commercialization plan that would leverage the results of the current Phase 3 study.





