Revive Therapeutics Ltd. (OTCMKTS:RVVTF) has announced an update on its US FDA third phase clinical study evaluating Bucillamine’s safety and efficacy in patients having mild-to moderated coronavirus.
Revive expanding its Phase 3 efficacy and safety study of Bucillamine
With the recent $23 million financings, Revive plans to expand from its current 14 clinical sites to 50 clinical sites, to meet enrolment targets for the trial in Q2 2021. The double-blind, randomized, placebo-controlled study whose efficacy and safety data was analyzed on an interim basis at a time point of 210, 400, 600, and 800 enrolled patients. The company has submitted the data to the Independent Data and Safety Monitoring Board for review and recommendation on whether to continue, stop or change the study design. If there will be safety concerns, the company will notify the DSMB to determine risk and offer a recommendation. So far, in the interim results at the initial 210 point, no serious safety concerns have been witnessed requiring the attention of the DSMB. Revive plans to meet the FDA for approval for Emergency Use Authorization for Bucillamine in treating mild to moderate COVID-19 patients.
Michael Frank, the company’s CEO, said that with the company completing funding, it is going to add more clinical sites to help it meet enrolment goals and meet the FDA to establish the way forward for EUA approval. Frank said that the company is committed to achieving its objective of making Bucillamine the first orally administered drug with FDA approval and EUA for mild-to-moderate COVID-19 treatment.
Revive to acquire PharmaTher Inc.
The company recently signed an asset purchase agreement with News cope Capital Corporation (OTCMKTS:PHRRF) to acquire PharmaTher Inc.’s IP pertaining to psilocybin. PharmaTher, a subsidiary of Newscope, is a specialty sciences firm focusing on psychedelic pharmaceuticals research and development. According to the agreement, Revive will pay up to C$10 million for the acquisition with $3 million payable at closing, $4 million through the issuance of Revive securities, and the remain $3 million will be subject to certain milestones and Revive obtaining Orphan Drug Designation for psilocybin in stoke treatment.