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

In a press release and a letter to the FA community, Solid Biosciences announced today, January 12, 2026, that the first participant has been dosed in FALCON, a Phase 1b, open-label, dose-finding clinical trial.

This trial is designed to evaluate the safety and tolerability of SGT-212 in individuals aged 18-40 living with FA. This study evaluates a novel, first-in-class FA gene therapy approach that uses dual routes of administration comprised of an intradentate nucleus (IDN) infusion, targeting the cerebellar dentate nuclei, followed by an intravenous (IV) infusion.

By leveraging this dual-route approach, they aim to address the neurologic, cardiac, and systemic manifestations of FA.

Learn more about the SGT-212 program on our pipeline page.