Sagimet is developing a portfolio of novel therapeutics called fatty acid synthase (FASN) inhibitors that target dysfunctional metabolic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. FASN is a regulator of lipid synthesis and a key pathway implicated in multiple diseases, such as NASH, acne and certain FASN-dependent tumor types.
Our lead product candidate, denifanstat (formerly known as TVB-2640), is an oral, selective first-in-class FASN inhibitor currently in a Phase 2b clinical trial (FASCINATE-2) for the treatment of patients with moderate-to-advanced NASH. We announced positive interim trial results in November 2022, and expect to report top-line 52-week data with biopsy results in the first quarter of 2024.
In July 2019, Sagimet announced that it had granted Ascletis a license to develop and commercialize denifanstat in Greater China. Under that license agreement, Ascletis is evaluating denifanstat in a Phase 3 clinical trial for recurrent glioblastoma and expects to enroll approximately 120 patients as the basis for an interim analysis in the third quarter of 2023. Ascletis is also testing denifanstat in a Phase 2 trial for acne in China, and in May 2023, announced positive data that met primary and key secondary endpoints in the trial. Based on these results, we are evaluating options to move forward with our own acne program in the US, Europe, and other markets.