Edgewise distances from researcher criticized by FDA
BOULDER — Edgewise Therapeutics Inc. (Nasdaq: EWTX), a Boulder-based muscle disease biopharmaceutical company, has clarified its relationship with a clinical researcher who recently received a warning letter from regulators following a U.S. Food and Drug Administration laboratory inspection, stressing that the FDA’s criticism was unrelated to Edgewise.
In late November, the FDA informed Han Phan, CEO of Rare Disease Research LLC, an Atlanta company that helps pharmaceutical companies conduct clinical trials, that during an April inspection it observed “objectionable conditions” in Phan’s lab, which failed to follow certain protocols during a drug study.
“This warning letter is unrelated to any Edgewise clinical trial or data. None of the Edgewise clinical trials are the subject of the FDA’s warning letter,” Edgewise said. “Edgewise has audited Dr. Phan’s site multiple times and believes that the data related to the Edgewise clinical trials at the site are being acquired and stored in accordance with FDA requirements.”
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The company’s drug candidate, sevasemten, is used in the treatment of Becker muscular dystrophy and Duchenne muscular dystrophy. Sevasemten is an investigational orally administered small molecule designed to prevent contraction-induced muscle damage, the company said in a press statement. Sevasemten is in late-stage clinical trials for individuals with Becker and is also being studied in Duchenne.
Edgewise Therapeutics has clarified its relationship with a clinical researcher who recently received a warning letter from regulators.
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