Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF) announced that its U.S. Food and Drug Administration (FDA) Phase 3 clinical trial study evaluating the safety and efficacy of Bucillamine— an oral drug with anti-inflammatory and antiviral properties — in patients with mild to moderate coronavirus (COVID-19) has screened approximately 700 subjects to date.
The company said that it has decided to fill a part of its patient enrollment quota outside of the U.S. and target Eastern Europe, such as Turkey, where the reported cases of COVID-19 are high with 32,176 new COVID-19 infections reported on December 28, 2021.
The decision to enroll patients outside the U.S. was made to ensure a diversified patient population to support future global regulatory submissions for Bucillamine, including the FDA, and follows Phase 3 clinical studies and FDA approvals of oral antiviral treatments by Pfizer and Merck.
In addition, Revive Therapeutics in collaboration with Delta Health will add research sites from the largest hospital group in Turkey, MLP Care, and Istinye University, which has 30 directly-owned hospitals in 15 cities and its affiliated university medical centers for a combined capacity of over 6,000 in-patient hospital beds across Turkey.
"We are now focused on completing the Phase 3 study in a manner which will provide practical antiviral, anti-inflammatory, and a diversified patient population. With the recent onset of the Omicron variant, we have made some of the above adjustments to the trial,” Michael Frank, CEO of Revive Therapeutics, said in a statement.
As a result of the company’s plans to diversify its patient population globally, incorporate viral load and anti-inflammatory markers, and its ongoing discussions with international pharmaceutical companies seeking to obtain commercial rights to Bucillamine as a treatment for COVID-19 in various countries in Europe, India, and Asia, the Phase 3 clinical study enrollment completion period is expected in the first quarter of 2022.
Revive Therapeutics said that it still expects to file an Emergency Use Authorization (EUA) with the FDA if the blinded results provide evidence to the DSMB’s final review to recommend pursuing EUA for Bucillamine to treat mild to moderate COVID-19.
Contact Ritika at ritika@proactiveinvestors.com