Atamyo Therapeutics Reports the US FDA’s IND Clearance of ATA-200 for Treating Limb-Girdle Muscular Dystrophy Type 2C/R5 (LGMD2C/R5)
Shots:
- The US FDA has cleared the IND application of ATA-200 to initiate the P-Ib/IIb clinical evaluation for limb-girdle muscular dystrophy type 2C/R5 (LGMD2C/R5). ATA-200 also received the FDA’s ODD for the same
- The P-Ib dose escalation trial will assess the safety, PD, efficacy & immunogenicity of ATA-200 among children with the recruitment set to begin in Q4’24; trial is funded by The Dion Foundation for Children with Rare Diseases. It has also received regulatory clearance in France & Italy
- ATA-200 is a one-time gene therapy for LGMD2C/R5, that transfers a normal gene for producing γ-sarcoglycan. It showed tolerability and symptom correction in non-clinical studies
Ref: Atamyo Therapeutics | Image: Atamyo Therapeutics
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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.
