Sagimet Biosciences Gets FDA Breakthrough Therapy Designation For Denifanstat

(RTTNews) - Sagimet Biosciences Inc. (SGMT) Tuesday said the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to denifanstat for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis.

Breakthrough therapy designation of denifanstat was supported by positive data from the Phase 2b FASCINATE-2 study in biopsy-confirmed MASH patients with stage 2 or stage 3 fibrosis.

The company plans to initiate a Phase 3 study of denifanstat in MASH by the end of 2024.

Drugs that receive breakthrough therapy designation are eligible for all the benefits of fast track designation, as well as intensive guidance by FDA on an efficient drug development program and organizational commitment involving FDA senior managers.