Global – October 27, 2026 -- Solid Biosciences has dosed the first participant in FALCON, a Phase 1b trial of SGT-212, its investigational gene therapy for Friedreich's ataxia (FA), and expects to release an initial data update in the second half of 2026, subject to patient enrollment.
FALCON tests a dual-route gene therapy in adults aged 18-40
FALCON is an open-label, dose-finding study designed to evaluate the safety and tolerability of SGT-212 in people aged 18-40 living with FA. Solid describes the approach as novel and first-in-class. It is the first-in-human study of SGT-212.
Intradentate nucleus infusion precedes intravenous delivery
Each participant receives an intradentate nucleus (IDN) infusion targeting the cerebellar dentate nuclei, followed by an intravenous (IV) infusion. Solid says the dual routes are intended to address the neurologic, cardiac and systemic manifestations of FA.
Enrollment is limited to a single site at launch
The study is small and currently active at its first site. Annie Ganot, Solid's co-founder and head of patient advocacy, said not everyone interested will be able to take part in the initial trial. The company hopes to widen participation through future study expansion.
Solid credited the Friedreich's Ataxia Research Alliance (FARA) with guiding and supporting the clinical program. The trial is listed on ClinicalTrials.gov under NCT07180355.
Community webinar planned within months, data in 2H 2026
Solid plans written updates and a dedicated community webinar in the coming months. The initial FALCON data update depends on how quickly patients enroll.