NEWS
Sagimet Receives FDA Breakthrough Therapy Designation for Denifanstat in Mash
Sagimet Biosciences Inc. (Nasdaq: SCMT)
announced that the FDA has granted Breakthrough Therapy designation to denifanstat for treating noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis.
announced that the FDA has granted Breakthrough Therapy designation to denifanstat for treating noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis.
This designation was supported by positive data from the Phase 2b FASCINATE-2 trial, where denifanstat showed statistically significant improvements in MASH resolution and fibrosis reduction.
The company plans to initiate a Phase 3 clinical program for denifanstat in MASH by the end of 2024.
Denifanstat, as the only fat synthesis inhibitor targeting the three main drivers of MASH (fat accumulation, inflammation, and fibrosis), demonstrated efficacy in meeting primary and secondary endpoints in the trial. The treatment was generally well-tolerated, positioning it as a potential leading treatment option for MASH patients.
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