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Solid Biosciences' SGT-003 Shows Robust Microdystrophin Expression, DAPC Restoration, Cardiac Function Improvements And Encouraging Safety Profile In 40 INSPIRE DUCHENNE Participants; Plans For Additional Meetings With The FDA In H1 2026

Benzinga·03/11/2026 17:03:57
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- 40 participants have been dosed with SGT-003 in the INSPIRE DUCHENNE trial to date -

- Robust microdystrophin expression with consistent mechanistic evidence of dystrophin associated protein complex (DAPC) restoration and improvements in muscle integrity, including stabilization and improvement in cardiac function (LVEF) observed after treatment with SGT-003 -

- SGT-003 continued to demonstrate an encouraging safety profile and has been generally well tolerated in the 40 participants dosed as of March 11, 2026 -

- SGT-003 is administered using a lower-burden, steroid-only prophylactic immunomodulation regimen -

- The Company plans for additional meetings with the FDA in H1 2026 for guidance on a potential accelerated approval pathway for SGT-003 and expects to provide an update mid-2026 -

CHARLESTOWN, Mass., March 11, 2026 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (NASDAQ:SLDB) (the "Company" or "Solid"), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today reported updated positive interim data from the ongoing Phase 1/2 INSPIRE DUCHENNE clinical trial of SGT-003. The new data, including additional muscle biopsy, serum biomarker, cardiac function, and safety analyses, add to a growing dataset that suggests the potential of the biological activity of SGT-003 microdystrophin therapy. The interim update was delivered in an oral presentation at the 2026 MDA Annual Meeting on March 11, 2026, by Aravindhan Veerapandiyan, M.D., Director of the Comprehensive Neuromuscular Program and Co-Director of the Muscular Dystrophy Association Care Center at Arkansas Children's Hospital, and principal investigator in the INSPIRE DUCHENNE trial.