Solid Biosciences(US:SLDB) Globenewswire·2026-02-09 13:00Core Insights - Solid Biosciences has aligned with the FDA on the Phase 3 trial design for SGT-003, a potential treatment for Duchenne muscular dystrophy [1][2] - The company anticipates the first participant dosing in the Phase 3 trial, IMPACT DUCHENNE, in Q1 2026 [1] - Solid plans to hold additional meetings with the FDA in the first half of 2026 to discuss a potential accelerated approval pathway for SGT-003 [1][3] Clinical Trials - The Phase 3 trial, IMPACT DUCHENNE, will be a randomized, double-blind, placebo-controlled study targeting ambulant participants aged 7 to less than 12 years [2][8] - The primary endpoint for the trial is the change from baseline in Time to Rise (TTR) velocity evaluated at 18 months, along with other key secondary endpoints [2] - The ongoing Phase 1/2 trial, INSPIRE DUCHENNE, has dosed 36 participants as of February 9, 2026, and SGT-003 has been generally well tolerated [4] Regulatory Strategy - The successful alignment with the FDA on the Phase 3 trial design is seen as a critical step in the company's regulatory strategy for SGT-003 [3] - The company is evaluating the potential to open trial sites in the U.S. due to strong demand from key opinion leaders and patients [3] Product Information - SGT-003 is an investigational gene therapy designed to treat Duchenne muscular dystrophy, featuring a differentiated microdystrophin construct and a proprietary capsid [6] - The therapy aims to enhance cardiac and skeletal muscle transduction while reducing liver targeting, potentially making it a best-in-class option for Duchenne treatment [6] Disease Background - Duchenne muscular dystrophy is a genetic muscle-wasting disease primarily affecting boys, with symptoms typically appearing between ages three and five [5] - The disease has an estimated prevalence of 5,000 to 15,000 cases in the United States, affecting approximately one in every 3,500 to 5,000 live male births [5]