Edgewise Therapeutics has commenced the CANYON Phase II clinical trial of EDG-5506 to treat individuals with Becker Muscular Dystrophy (BMD).

The small molecule myosin modulator, EDG-5506 can be administered orally and has been designed to offer protection to injury-susceptible fast skeletal muscle fibers in BMD and Duchenne muscular dystrophy (DMD).

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At present, no approved treatments are available for BMD.

The placebo-controlled CANYON trial is expected to enrol around 66 subjects at up to 14 study sites in the UK, US and the Netherlands.

In this trial, the effect of EDG-5506 will be evaluated for 12 months on pharmacokinetics (PK), safety, biomarkers such as creatine kinase (CK), and functional measures in BMD individuals aged 12 years and above.

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Edgewise Therapeutics chief medical officer Joanne Donovan said: “We are delighted to advance EDG-5506 into Phase II, based on the safety and positive biomarker data observed in our Phase I and ARCH studies.

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“In the CANYON trial, we aim to understand the effect of EDG-5506 on circulating biomarkers, muscle MRI, and functional measures, all of which could provide indications of a treatment effect.”

The US Food and Drug Administration granted Fast Track designation to EDG-5506 in August last year to treat individuals with BMD.

EDG-5506, which is anticipated to be used as a monotherapy, exhibits a new mechanism of action designed to selectively restrict the exaggerated muscle damage that is caused due to the absence of functional dystrophin.

BMD is a progressively debilitating, serious as well as potentially fatal inherited X-linked neuromuscular disorder and is also linked to early mortality from cardiac disease.

Last month, Edgewise reported positive two-month interim data from the ARCH study of EDG-5506 in adults with BMD.