SpliceBio Receives the US FDA IND Clearance to Initiate P-I/II Trial of SB-007 for Treating Stargardt Disease
Shots:
- The US FDA approved IND application of SB-007 to conduct its P-I/II trial assessing SB-007 in Stargardt patients with ABCA4 mutation
- The P-I/II (ASTRA) study assessing safety & efficacy of a single subretinal dose of SB-007 in Stargardt patients, study plans to initiate recruitments in H1’25. Trial is built on company-sponsored POLARIS study evaluating disease progression & refine endpoints
- SB-007 is a protein-splicing dual AAV gene therapy that transfers full-length ABCA4 gene to restore native ABCA4 protein expression in the retina. It holds the EC’s & US FDA’s ODD for the same
Ref: SpliceBio | Image: SpliceBio
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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.
