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Edgewise Therapeutics: FDA Authorization for Phase 2 Clinical Trial of EDG-5506

septembre 8, 2022

The Food and Drug Administration in the United States (FDA) has authorized the Edgewise Therapeutics Phase 2 clinical trial, Lynx (EDG-5506), for the treatment of Duchenne muscular dystrophy.

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 four and up to their 10th birthday on stable corticosteroids, are expected to enroll 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.

“This is an important achievement for our team as we seek to expand our studies with EDG-5506 into individuals with DMD. Our team has worked with key opinion leaders and patient advocacy groups to thoughtfully design our LYNX Phase 2 clinical trial. The promising tolerability and changes in biomarkers of muscle damage that we have seen in studies with EDG-5506 in individuals with BMD support our next step of expanding enrollment to individuals with DMD.”

Joanne Donovan, M.D., Ph.D., Chief Medical Officer of Edgewise

Join us at our Family Forum on November 4-6, 2022, where Edgewise Therapeutics will provide additional updates and an opportunity for Q&A.