Gannan Medical University

Ascletis Pharma on Tuesday said its oral FASN inhibitor denifanstat — in-licensed from Sagiment Biosciences for Greater China rights — met all primary and secondary endpoints in a Phase III study for the treatment of moderate-to-severe acne vulgaris, paving the way for a marketing application in the country. The trial randomised 480 patients in China to receive either denifanstat once daily or placebo for 12 weeks. For the primary endpoint of treatment success — defined as an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease from baseline at week 12 — the denifanstat group demonstrated a statistically significant 33.2% success rate over the placebo group’s 14.6%.Additional primary goals further corroborated denifanstat's efficacy versus placebo: reduction in total lesion count (57.4% vs 35.4%) and reduction in inflammatory lesion count (63.5% vs 43.2%). Moreover, a key secondary endpoint showed a significant 51.9% reduction in non-inflammatory lesion count for denifanstat versus 28.9% for placebo.“Denifanstat…demonstrated impressive efficacy beyond treatment success," said Jinzi Jason Wu, chief executive of Ascletis, adding that the drug will "soon" be submitted to the China National Medical Products Administration (NMPA).In terms of safety, denifanstat exhibited a favourable profile, with the incidence of treatment-emergent adverse events (AEs) comparable to placebo. All treatment-related AEs were mild or moderate, with no denifanstat-related Grade 3 or 4 events, serious AEs or deaths reported.Besides acne, denifanstat — also known as ASC40 — is being investigated for metabolic dysfunction-associated steatohepatitis (MASH), where it has delivered positive findings in a Phase IIb study, and is also undergoing late-stage testing in combination with bevacizumab for recurrent glioblastoma.