SpliceBio, Announces

SpliceBio Announces U.S. FDA IND Clearance of SB-007 to Commence Phase 1/ 2 Clinical Study in Patients with Stargardt Disease

Published on 08/07/2025 at 18:06 | prnewswire.co.uk

SpliceBio Indiana Spain

SB-007 is the only IND-cleared, clinical-stage therapeutic addressing the root cause of Stargardt disease with the potential to treat all patients across all ABCA4 mutations Phase 1/2 ASTRA study set to begin in the first half of 2025, supported by POLARIS, a pioneering company-sponsored natural history study in Stargardt disease First ever IND clearance for a Protein Splicing gene therapyView original content:https://www.prnewswire.co.uk/news-releases/splicebio-announces-us-fda-ind-clearance-of-sb-007-to-commence-phase-12-clinical-study-in-patients-with-stargardt-disease-302329361.html

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