Edgewise has announced the FDA has authorized Phase 2 clinical trial for the treatment of Duchenne. The Lynx trial is a placebo-controlled trial to assess the effects of three doses of EDG-5506, over 12 weeks on safety, pharmacokinetics, and biomarkers of muscle damage. All patients will continue in an open-label extension for a total of 12 months of study.
Approximately 27 children with Duchenne, ages 4 and up to their 10th birthday on stable corticosteroids, are expected to enrol at up to 12 sites across the US. Edgewise expects to begin dosing participants in the 4th quarter of 2022. EDG-5506 is an investigational orally administered small molecule myosin modulator designed to protect injury susceptible fast skeletal muscle fibres in Duchenne and certain other dystrophinopathies.
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