Ascletis Pharma Inc. (HKEX: 1672) today announced positive topline results from its Phase 3 study for Denifanstat, a once-daily oral fatty acid synthase (FASN) inhibitor for moderate-to-severe acne vulgaris, a common dermatological condition that significantly impacts patient's quality of life.
The recently completed phase 3 study was an open-label, multicenter trial in China designed to evaluate the long-term safety of Denifanstat (ASC40), in 240 patients with moderate-to-severe acne vulgaris. All patients, previously treated with Denifanstat or placebo for 12 weeks, received Denifanstat once daily for 40 weeks.
The primary endpoint included incidence of treatment-emergent adverse events (TEAEs), incidence of serious adverse events (SAEs), and incidence of discontinuation due to adverse events (AEs). Denifanstat demonstrated a favorable safety and tolerability profile. Most TEAEs were mild (grade 1) and moderate (grade 2). There were no Denifanstat-related grade 3 or 4 AEs and no Denifanstat-related SAEs. No deaths were reported.
In June 2025, Ascletis announced that Denifanstat met all primary, key secondary, and secondary endpoints in a 480-patient randomized, double-blind, placebo-controlled Phase 3 clinical trial for moderate-to-severe acne vulgaris.
The mechanism of action of Denifanstat for acne treatment is direct inhibition of sebum production through inhibition of de novo lipogenesis (DNL) in human sebocytes, and inhibition of inflammation, through decreasing cytokine secretion and Th17 differentiation.
Denifanstat's unique mechanism of action directly reduces one of the main underlying causes of acne, setting it apart from most other treatments that do not address sebum overproduction.
Denifanstat is licensed from Sagimet Biosciences Inc (SGMT) for exclusive rights in Greater China.
HKEX: 1672 has traded between HKD 3.76 and HKD 18.75 over the past year. The stock closed yesterday's trading at HKD 13.58, up 2.49%.
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