Solid Biosciences reports interim SGT-003 Duchenne trial data, 40 participants dosed
Solid Biosciences released new interim clinical data from its Phase 1/2 INSPIRE DUCHENNE trial of SGT-003, a one-time gene therapy for pediatric Duchenne muscular dystrophy, using a February 23, 2026 data cutoff. The company said SGT-003 has been generally well tolerated in 40 participants dosed as of March 11, 2026, and reported biomarker changes at Day 90 and Day 360 in small subsets of participants. The data are interim and based on small numbers, and the company said it expects a Phase 3 IMPACT DUCHENNE trial to begin dosing in the first quarter of 2026.
Key points
- 40 participants dosed as of March 11, 2026; data cutoff February 23, 2026
- Mean microdystrophin expression by western blot was 60% at Day 90 (n=19) and 91% at Day 360 (n=3)
- Mean 44% reduction in eMHC-positive fibers at Day 90 (n=20); serum creatine kinase down 38% at Day 90 (n=24)
- Company plans additional FDA meetings in the first half of 2026 and expects further updates in mid-2026
The filing
Written by AI on Nov 9, 2026, 8:53 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on March 11, 2026.
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