Solid Biosciences’ SGT-212 Secures the US FDA’s Fast Track Designation for Treating Friedreich’s Ataxia
Shots:
- The US FDA has granted FTD to SGT-212 for treating Friedreich’s ataxia (FA) and previously approved its IND on Jan 07, 2025
- The P-Ib study will assess safety & tolerability of contemporaneous systemic IV and bilateral IDN administration of SGT-212 in non-ambulatory and ambulatory FA patients for 5yrs., with dosing anticipated during H2’25
- SGT-212 is a recombinant AAV-based gene therapy that transfers full-length human frataxin via intradentate nucleus (IDN) in the cerebellar dentate nuclei & IV infusion in the cardiomyocytes. The IDN delivery will be confirmed in real-time using gadolinium MRI contrast agent
Ref: Solid Biosciences | Image: Solid Biosciences
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
