Sangamo Therapeutics Receives U.S. FDA Fast Track Designation for Isaralgagene Civaparvovec
Monday, May 22, 2023
Sangamo Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to isaralgagene civaparvovec, or ST-920, a wholly owned gene therapy product candidate for the treatment of Fabry disease.
Isaralgagene civaparvovec requires a one-time infusion without preconditioning. The STAAR study is enrolling patients who have received ERT, are ERT pseudo-naïvoe (defined as having been off ERT for six or more months), or are ERT-naïvoe.
The Phase 1/2 STAAR study is a global open-label, single-dose, dose-ranging, multicenter clinical study designed to evaluate the safety and tolerability of isaralgagene civaparvovec, or ST-920, a gene therapy product candidate in patients with Fabry disease. ST-920 is currently being evaluated in the Phase 1/2 STAAR study, with a total of 20 patients dosed to date.
This FDA decision highlights the potential of ST-920 to address a serious unmet need and be a useful treatment option for patients with Fabry disease.
