Cellceutix files with FDA for Phase 2b clinical trial of novel antibiotic

Graphic taken from company website.
Graphic taken from company website.

Cellceutix Corp., a clinical stage biopharmaceutical company headquartered in Beverly, said that the protocol for the Phase 2b trial of a drug candidate called Brilacidin has been sent to the US Food and Drug Administration.

In addition, the company said that its submission to ClinicalTrials.gov for this upcoming Phase 2b clinical trial of Brilacidin for Acute Bacterial Skin and Skin Structure Infections, ABSSSI, has been accepted. In its press release, Cellceutix added that it expects that trial recruitment of patients will begin in mid-February.

‘‘We are within a few weeks of a milestone moment for our company with the commencement of the Brilacidin trial for ABSSSI,’’ company chief executive Leo Ehrlich said in a statement. ‘‘We have made it very clear that we have high expectations for Brilacidin ever since we acquired it in September. I am very proud of the commitment and efficiency of our team, which in less than five months, completed requisite lab work and regulatory filings to have this important clinical trial ready to begin. With optimized dosing, we believe that Brilacidin can represent a major breakthrough in the field of antibiotics.”

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