Edgewise launches first clinical trials for muscular dystrophy drug candidate

BOULDER — Edgewise Therapeutics Inc. has begun recruiting its first-ever clinical trial for its flagship muscular dystrophy treatment.

The Boulder company said last week that it will begin recruiting approximately 152 healthy volunteers and adults with Becker muscular dystrophy for Phase I trials in San Antonio. It intends to complete the study by October 2021.

EDG-5506 is a genetic treatment for Becker muscular dystrophy, a type of MD that causes progressive muscle weakness in the legs and pelvis that affects an estimated one in 17,000 newborn males worldwide.

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The drug is also thought to have benefits for patients with Duchennes MD that attacks the entire body and limb-girdle MD that attacks the legs and arms.

All three of those muscular dystrophy types are thought to be caused by mutations in the gene that creates dystrophin, a key part of the protein complex that helps develop muscle strength. 

As of late 2020, the U.S. Food and Drug Administration has only approved two other drugs that target specific types of dystrophin mutations for use. Otherwise, patients are mainly limited to using steroids and physical therapy for much of their lives.

“We look forward to the results of our Phase 1 trial, which will help us select the optimal dose of EDG-5506 for pivotal clinical studies in these patient populations,” Edgewise CEO Kevin Koch said in a statement.

Edgewise closed a $50 million Series B round last September, and has a total of $65.5 million in venture capital investment.

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