Revive Files Pre-IND Meeting With FDA For COVID-19 Treatment
Revive Therapeutics (CSE: RVV) this morning announced that it has filed its pre-investigational new drug (Pre-IND) meeting request with the US Food and Drug Administration for the use of Bucillamine as a treatment against coronavirus and other infectious diseases.
Revive is currently relying on its previous investigative work with Bucillamine to assist in expediting communications with the FDA, with the goal of being approved for a phase 2 clinical study. The company has previously received phase 2 study approval for Bucillamine for the use of the drug as a treatment for gout and cystinuria.
The company is currently working with its contract research organization, Pharm-Olam, to finalize the protocol to be used in the proposed phase 2 clinical trial. The protocal, as currently developed, proposed a multi-center, randomized, double-blind, placebo-controlled, clinical study. The study will focus on patients with coronavirus currently exhibiting mild to moderate symptoms, with the objective of evaluating the course of the disease in patients receiving Bucillamine as compared to those receiving the placebo.
The study is to also analyze the safety of Bucillamine when administered for up to 14 days, and the time it takes to note clinical improvement in those receiving Bucillamine treatment versus those receiving the placebo.
We are excited to expedite the clinical investigation of Bucillamine in a proposed phase 2 clinical study in the U.S., and we believe our history with the FDA for Bucillamine will provide a compelling case. We will also seek to expand the clinical investigation of Bucillamine in Asian regions, with a particular interest in Japan and South Korea where Bucillamine has been prescribed for treating arthritis for over 30 years. We are in discussion with various contract research organizations (‘CRO’) in these regions.
Michael Frank, Revive’s Chief Executive Officer
Revive Therapeutics last traded at $0.12 on the CSE.
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