08:39 AM EDT, 06/06/2024 (MT Newswires) -- Sagimet Biosciences ( SGMT ) said Thursday that additional data from a phase 2b trial of denifanstat in patients with biopsy-confirmed metabolic dysfunction-associated steatohepatitis, or MASH, showed that the study met the primary and secondary endpoints.
Denifanstat, an oral daily pill, achieved statistically significant results on primary and secondary liver biopsy endpoints in the intention to treat, or ITT, population, including FDA-recommended histology endpoints for accelerated MASH approval, Sagimet said.
The drug significantly improved liver fibrosis stages without worsening MASH in the ITT and F3 populations, including those with stage 3 fibrosis, according to Sagimet.
No serious treatment-related adverse events occurred, and most adverse events were mild to moderate, the company said.
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