Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF) told investors it is on track to complete study enrollment of its Phase 3 clinical trial (NCT04504734) to evaluate the safety and efficacy of Bucillamine in patients with mild to moderate coronavirus (COVID-19) in the first quarter of 2022.
In an update on the status of the trial for Bucillamine, an oral drug with anti-inflammatory and antiviral properties, the Toronto-based company said it is also preparing its regulatory package for submission to the US Food & Drug Administration (FDA) and international regulatory authorities for drug approvals.
"We are now in the final stages in our Phase 3 study and we are focused on completing enrollment, preparing the regulatory packages for the FDA and international health authorities, and negotiating manufacturing and marketing agreements with pharmaceutical companies for commercialization,” the company’s CEO Michael Franks said in a statement.
READ: Revive Therapeutics expands patient enrollment for Phase 3 clinical trial of Bucillamine for COVID-19 in Eastern Europe, Asia
The company noted that a total of 701 subjects have been dosed to date in the study. In collaboration with Delta Health, it said it has initiated the enrollment activities in Turkey at MLP Care, the largest hospital group in Turkey, and Istinye University with access to 30 research sites and over 6,000 in-patient hospital beds.
Revive said the study’s expansion into Turkey complements its global commercialization plan for Bucillamine as a potential treatment for mild to moderate COVID-19. As previously reported, in light of Phase 3 clinical studies and FDA approvals of oral antiviral treatments by Pfizer Inc (NYSE:PFE) and Merck and Co Inc, it said it was evident that to improve the study’s outcome, a diversified patient population from different countries is important to support future global regulatory submissions.
In addition, a diversified subject population supports ongoing discussions with pharmaceutical companies in Turkey and international markets, it said.
The company cautioned that it is not making any express or implied claims that its product can eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.
Revive Therapeutics is focused on the research and development of therapeutics for infectious diseases and rare disorders, and aims to take advantage of several regulatory incentives awarded by the FDA, such as orphan drug, fast track, breakthrough therapy and rare pediatric disease designations.
Contact the author at stephen.gunnion@proactiveinvestors.com