BOULDER — Edgewise Therapeutics (NASDAQ: EWTX) has successfully completed Phase 1 clinical trials for EDG-5506, its new muscular dystrophy drug.
According to a press statement, EDG-5506 is designed to treat two rare forms of the disorder: Becker muscular dystrophy and Duchenne muscular dystrophy. Both afflictions affect muscles of the hips, thighs, pelvic area and shoulders.
“We are extremely encouraged by these multiple ascending dose data, which clearly demonstrate high levels of target engagement with a well-tolerated dosing regimen,” said Joanne Donovan, chief medical officer of Edgewise. “We are excited by the potential that EDG-5506 may serve as an oral treatment to decrease muscle damage, the root cause of DMD and BMD, and we eagerly look forward to better understanding its full potential in future clinical studies.”
The trial involved 40 patients who were given oral doses of EDG-5506 or a placebo. EDG-5506 works by eliminating involuntary muscle twitches without affecting voluntary movements.
Edgewise expects to begin Phase 2 trials for the drug in the first half of 2022.
“We are excited about the results from this clinical trial of EDG-5506, which supports dosing of BMD patients in the Phase 1b and advancement of EDG-5506 into Phase 2,” said Kevin Koch, president and CEO of Edgewise. “We are working with urgency to forge ahead with the program and are enthusiastic about the potential of EDG-5506 to provide a meaningful therapeutic benefit for individuals with DMD and BMD.”
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