Solid Biosciences has shared an update on the company’s Phase 1/2 INSPIRE DUCHENNE trial evaluating SGT-003 for the treatment of individuals living with Duchenne. 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.
As of August 12, 2025, Solid reported that 15 participants have been dosed in the INSPIRE DUCHENNE trial with participant dosing ongoing across multiple cohorts. According to Solid, the company expects to activate additional trial sites and dose a minimum of 20 participants by the end of the year.
Solid expects to initiate a separate randomized, double-blind, placebo-controlled trial evaluating SGT-003 outside of the United States in the fourth quarter of 2025, with the aim of supporting potential global regulatory authorizations. The company indicated that it expects to meet with the U.S. Food and Drug Administration (FDA) in the fourth quarter of this year to discuss regulatory pathways for SGT-003.
Read Solid’s press release here.
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