Solid Biosciences Inc. has shared that the first participant has been dosed in IMPACT DUCHENNE, the company’s multi-country, placebo-controlled, randomized, double-blind, Phase 3 clinical trial investigating SGT-003 for the treatment of Duchenne muscular dystrophy. SGT-003 is a gene therapy candidate for the treatment of Duchenne that delivers a microdystrophin via their novel AAV capsid designed to increase skeletal and cardiac muscle targeting while detargeting the liver. 

According to Solid, clinical trial sites are currently active in Australia and Canada and additional site activations in the U.K. and U.S. are expected in the second half of 2026. Additionally, Solid noted that 46 participants have been dosed in the ongoing Phase 1/2 INSPIRE DUCHENNE clinical trial of SGT-003. The company reported that SGT-003 continues to demonstrate a favorable safety and tolerability profile.

In the U.S., Solid previously shared that they reached alignment with the FDA during a Type C meeting on the overall design of the IMPACT DUCHENNE Phase 3 trial, including the pre-specified primary endpoint measuring change from baseline in time to rise from supine (TTR) velocity at 18 months. According to Solid, the trial is expected to support potential regulatory pathways in both the U.S. and internationally, including possible accelerated approval by the FDA. SGT-003 has also received FDA Fast Track, Rare Pediatric Disease, and Orphan Drug designations, which may help support accelerated approval pathways and ongoing regulatory discussions. Solid reports that the company continues to engage with the FDA as development moves forward.

Read Solid’s press release here to learn more.