AAVantgarde Receives FDA Clearance to Progress Stargardt Disease Asset, AAVB-039, into CELESTE, ...

AAVantgarde Receives FDA Clearance to Progress Stargardt Disease Asset, AAVB-039, into CELESTE, ...

AAVB-039 delivers the full-length ABCA4 -protein, addressing the root cause of the disease and enabling treatment of all patients, independent of mutationCELESTE is informed by the STELLA prospective natural history study, which is currently enrolling patients in the United States…

AAVantgarde Receives FDA Clearance to Progress Stargardt Disease Asset, AAVB-039, into CELESTE, a Phase 1/2 Clinical Trial

AAVB-039 delivers the full-length ABCA4 -protein, addressing the root cause of the disease and enabling treatment of all patients, independent of mutationCELESTE is informed by the STELLA prospective natural history study, which is currently enrolling patients in the United States…

AAVantgarde Receives FDA Clearance to Progress Stargardt Disease Asset, AAVB-039, into Phase 1/2 Clinical Trial

AAVantgarde Bio announced that the FDA has cleared its investigational new drug (IND) application for AAVB-039, the company’s gene therapy program for Stargardt disease. AAVantgarde is now initiating CELESTE, a first-in-human phase 1/2 clinical trial in the United States to evaluate the safety, tolerability, and initial efficacy of AAVB-039 in patients with Stargardt disease.  AAVB-039 aims to address the underlying genetic cause of the disease …