Ascletis Reports Positive Results for ASC40 Clinical Trial
Sagimet Biosciences announced that Ascletis Pharma issued a press release on January 29th reporting positive topline results in the open-label Phase 3 trial evaluating the long-term safety of ASC40 tablets in patients with moderate to severe acne. Denifanstat is a once-daily oral small molecule fatty acid synthase, FASN, inhibitor being developed by Ascletis as ASC40 for acne in China and by Sagimet for MASH in the rest of the world. Sagimet has granted an exclusive license to denifanstat for China to Ascletis Bioscience, of which Ascletis Pharma is the parent company. Primary endpoints evaluated safety, and secondary endpoints evaluated efficacy, for up to 52 weeks of denifanstat treatment. Denifanstat was generally well tolerated, with the following: Treatment-emergent adverse events: Only two categories of TEAEs had an incidence rate of 5% or more, with dry eye syndrome in 5.5% of denifanstat-treated subjects and dry skin reported in 5.2% of denifanstat-treated subjects. Adverse events: All denifanstat-related AEs were mild or moderate; no denifanstat-related Grade 3 or 4 AEs; no AE-related permanent discontinuations; Grade 1 hair thinning in the study was experienced by only 1 denifanstat-treated patient; no deaths were reported. Serious adverse events: No denifanstat-related SAEs; 2 non-denifanstat-related SAEs, both resolved.
