Pharma Focus Asia

Revive Therapeutics Provides Update on Phase 3 Clinical Trial for Bucillamine in COVID-19

Monday, April 11, 2022

Revive Therapeutics Ltd., a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to provide an update on the Company’s U.S. Food & Drug Administration (“FDA”) Phase 3 clinical trial (the “Study”) (NCT04504734) 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 Data Safety and Monitoring Board (“DSMB”) are scheduled to meet this quarter to evaluate the current clinical and safety data to either make recommendations on the Study or advise on potentially halting the Study early due to positive efficacy based on other clinical outcomes evaluated such as the rate of sustained clinical resolution of symptoms of COVID-19. The Company believes that with the Omicron variant, including the BA.2 variant, being the dominant strain over the Delta variant and COVID-19 hospitalizations in the U.S. in decline, there is an urgent unmet need to treat symptom resolutions in addition to preventing hospitalizations. The Company has made efforts in determining the appropriate revised primary and secondary clinical endpoints for FDA consideration for potential Emergency Use Authorization. In parallel, the Company will continue enrollment activities in the U.S. and Turkey and is still targeting Q2-2022 to meet the enrollment goals.

“With COVID-19 cases on the rise and the need for alternative oral treatments that is relevant to the current state of the disease, we believe that Bucillamine’s anti-inflammatory and antiviral properties offers an alternative potential solution that is urgently needed globally to fight COVID-19 and allow for people to improve their quality of life,” said Michael Frank, CEO of Revive.

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.

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