Sagimet Biosciences announced that its license partner, Ascletis Bioscience, has enrolled 120 patients in its Phase 3 registration clinical trial of denifanstat combined with bevacizumab for treatment of recurrent glioblastoma, or rGBM. Ascletis anticipates that this number of study subjects will provide sufficient events for its planned interim analysis of progression-free survival, or PFS. Denifanstat is an oral, selective small molecule inhibitor of fatty acid synthase, or FASN, a key enzyme which regulates de novo lipogenesis, or DNL. Sagimet licensed the rights to develop and commercialize denifanstat in the People’s Republic of China, Hong Kong, Macau and Taiwan to Ascletis in January 2019. Sagimet’s FASCINATE-2 Phase 2b clinical trial for denifanstat in liver biopsy-confirmed F2-F3 nonalcoholic steatohepatitis, or NASH, patients is fully enrolled and biopsy results are expected in the first quarter of 2024. Sagimet also expects to report Phase 1 clinical trial results characterizing the pharmacokinetic profile of denifanstat in patients with impaired hepatic function in the first quarter of 2024.
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