(RTTNews) - Solid Biosciences (SLDB) announced that it has received Fast Track designation from the FDA for SGT-212, the company's, AAV-based gene therapy candidate for the treatment of Friedreichs ataxia. FDA IND clearance for SGT-212 was announced January 7th, 2025.
The company said the planned Phase 1b trial will be a first-in-human, open-label, multicenter study to evaluate the safety and tolerability of contemporaneous systemic IV and bilateral IDN administration of SGT-212 in adult non-ambulatory and ambulatory patients with FA. Dosing is expected to initiate in the second half of 2025 and participants in the trial will be followed for five years.
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