China-based Ascletis Pharma Inc. (HKG: 1672) has announced that ASC40 (denifanstat), a fatty acid synthase (FASN) inhibitor co-developed with US partner Sagimet Biosciences Inc. (NASDAQ: SGMT), has received a breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA). The designation is for the treatment of patients with fibrotic stage 2/3 metabolic dysfunction-associated steatohepatitis (MASH) confirmed by liver biopsy.
A 53-week study involving 168 patients with fibrotic stage 2 or 3 MASH, which concluded in January 2024, produced positive data for ASC40. The drug demonstrated statistically significant differences in its primary endpoint and multiple secondary endpoints. Ascletis holds the rights to the drug in Greater China. – Flcube.com
