Solid Biosciences Doses First Participant in First-in-Class Phase 1b FALCON Trial Evaluating SGT-212 Dual-Route Gene Therapy for the Treatment of Friedreich's Ataxia

Core Viewpoint - Solid Biosciences Inc. has initiated dosing in the FALCON trial, a Phase 1b clinical trial for SGT-212, a gene therapy aimed at treating Friedreich's ataxia (FA) [1][3] Group 1: SGT-212 and FALCON Trial - SGT-212 is a first-in-class gene therapy designed to address the neurological, cardiac, and systemic manifestations of FA through a dual-route administration [2][5] - The FALCON trial is an open-label, multi-center study evaluating the safety and tolerability of SGT-212 in participants aged 18-40 diagnosed with FA and cardiac hypertrophy [4] - The therapy aims to restore therapeutic levels of frataxin, which is crucial for mitochondrial function and overall cellular health [5][6] Group 2: Company Statements and Future Outlook - The Chief Medical Officer of Solid Biosciences expressed confidence in the precision of the MRI-guided delivery method, which exceeded expectations for targeting the intradentate nuclei [3] - The President & CEO highlighted the significance of the trial for the FA community and the company's commitment to addressing both quality of life and mortality drivers associated with the disease [3] - Preliminary safety insights are expected to be shared in the coming months, with an initial data update anticipated in the second half of 2026 [3]