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Edgewise Therapeutics Announces Initiation of LYNX Phase 2 Clinical Trial of EDG-5506 for the Treatment of Duchenne Muscular Dystrophy (DMD)
– Rare Disease Research, LLC first site activated to enroll children with DMD – – Edgewise to hold virtual webinars with the patient community to discuss
About this update from Edgewise Therapeutics, Inc.
[{"type":"text","content":"\n– Rare Disease Research, LLC first site activated to enroll children with DMD –\n\n– Edgewise to hold virtual webinars with the patient community to discuss EDG-5506 clinical trials in November –\n\n BOULDER, Colo.--(BUSINESS WIRE)--\nEdgewise Therapeutics, Inc., (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for the treatment of rare muscle disorders, today announced that it has initiated the LYNX Phase 2 clinical trial at Rare Disease Research, LLC in Atlanta, Georgia. The trial will examine the safety, pharmacokinetics (PK) and effect on biomarkers of muscle damage of EDG-5506 in children with DMD. The study will also explore changes in functional measures, such as the North Star Ambulatory Assessment (NSAA) and self-reported/caregiver-reported outcomes. EDG-5506 is an investigational orally administered small molecule myosin modulator designed to protect injury-susceptible fast skeletal muscle fibers in dystrophinopathies such as DMD and Becker muscular dystrophy (BMD).\n\nThe LYNX Phase 2 trial is a placebo-controlled trial to assess the effect of three doses of EDG-5506 over 12 weeks on safety, PK and biomarkers of muscle damage. After the initial 12 weeks, LYNX participants will then continue on open-label EDG-5506 for an additional 9 months to gain further insights into safety and functional measures. Approximately 27 children with DMD aged 4 to 9 years on stable corticosteroids are expected to be enrolled in this 12-month trial. Importantly, this trial is designed to identify the doses of EDG-5506 that have the potential to reduce biomarkers of muscle damage and provide functional benefit to patients in a Phase 3 trial. The research center in Atlanta is the first site to be activated to enroll children with DMD. Up to 12 investigative sites across the United States are expected to participate in the trial.\n\n“We are very pleased to begin this important clinical trial of EDG-5506,” said Han C. Phan, M.D., Head of Research & Principal Investigator, Pediatric Neurologist, Rare Disease Research, LLC. “Having studied EDG-5506 over the past year in individuals with Becker with promising results, I’m excited to see the potential of EDG-5506 in children with Duchenne.”\n\n“Our team has worked with experts and patient advocacy groups to thoughtful...