The US Food and Drug Administration (FDA) has granted fast track designation for AAVB-039, AAVantgarde Bio’s gene therapy program for Stargardt disease secondary to biallelic mutation in ABCA4, the company reported in a press release.

According to AAVantgarde Bio, AAVB-039 addresses the underlying genetic cause of the disease by providing the full-length ABCA4 protein and has the potential to benefit all patients with ABCA4 mutations.

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. AAVB-039 is currently being evaluated in the phase 1/2 CELESTE clinical trial, which is assessing safety, tolerability, and preliminary efficacy in patients with Stargardt disease, the company said. RP