Solid Biosciences Doses First Patient in Phase 1b FALCON Trial of AAV Gene Therapy SGT-212 for Friedreich’s Ataxia

CHARLESTOWN, Mass., Jan. 12, 2026 — Solid Biosciences Inc. (Nasdaq: SLDB) announced that the first participant has been dosed in FALCON, a Phase 1b, first-in-human clinical trial evaluating SGT-212, an investigational adeno-associated virus (AAV) gene therapy for the treatment of Friedreich’s ataxia (FA).

SGT-212 is a first-in-class AAV-based gene replacement therapy designed to restore therapeutic levels of frataxin (FXN) using a dual-route delivery strategy. The approach combines stereotactic, MRI-guided intradentate nucleus infusion targeting the cerebellar dentate nuclei, followed by systemic intravenous AAV administration to address neurologic, cardiac, and systemic manifestations of FA.

Real-time intra-procedural MRI confirmed accurate targeting and coverage of the dentate nuclei, supporting the precision of the AAV gene delivery strategy. The FALCON trial is an open-label, multi-center Phase 1b study enrolling adults aged 18–40 with Friedreich’s ataxia and cardiac hypertrophy in the United States.

Initial safety observations are expected in the coming months, with an initial clinical data update anticipated in the second half of 2026. Friedreich’s ataxia is a rare, life-threatening neurodegenerative disease with no curative therapies currently available, driven by FXN deficiency and associated mitochondrial dysfunction.