Biotechnology company Ascletis Pharma Inc (HKEX:1672) on Thursday reported positive topline results from the Phase III open-label study of denifanstat (ASC40), a first-in-class, once-daily oral small molecule fatty acid synthase (FASN) inhibitor, in patients with moderate-to-severe acne vulgaris.

This second Phase III study was an open-label, multicentre study in China designed to evaluate the long-term safety of denifanstat (ASC40) in 240 patients with moderate-to-severe acne vulgaris. All the 240 patients, previously treated with denifanstat (ASC40) or placebo for 12 weeks, received denifanstat (ASC40) once daily for 40 weeks.

Primary endpoints included: incidence of treatment-emergent adverse events (TEAEs); incidence of serious adverse events (SAEs); and incidence of discontinuation due to adverse events (AEs). Denifanstat (ASC40) demonstrated a favourable safety and tolerability profile, with most TEAEs classed as mild (grade 1) or moderate (grade 2). There were no treatment-related grade 3 or 4 AEs or SAEs, and no deaths were reported.

Denifanstat (ASC40) is licensed by Ascletis from Sagimet Biosciences Inc (Nasdaq:SGMT) for exclusive rights in Greater China.