Full Press Release Details
-Denifanstat (ASC40), aonce-daily oral fatty acid synthase (FASN) inhibitor, demonstrated favorable safety and tolerability in a Phase III open-label study
-The exceptional efficacy of denifanstat (ASC40) observed in the Company's previously reported placebo-controlled Phase III trial coupled with a favorable safety profile in two Phase III trials provide a potential major break-through for the treatment of acne
-New Drug Application for denifanstat (ASC40) for acne was recently accepted by the China National Medical Products Administration
HONG KONG,Jan. 29, 2026/PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") today announced positive topline results from the Phase III open-label study (NCT06248008) evaluating 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 recently completed second Phase III study was an open-label, multicenter 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. The primary endpoints included: (1) incidence of treatment-emergent adverse events (TEAEs); (2) incidence of serious adverse events (SAEs); and (3) incidence of discontinuation due to adverse events (AEs). Denifanstat (ASC40) demonstrated a favorable safety and tolerability profile. Most TEAEs were mild (grade 1) and moderate (grade 2). There were no denifanstat (ASC40)-related grade 3 or 4 AEs and no denifanstat (ASC40)-related SAEs. No deaths were reported.
In June 2025, Ascletis announced that denifanstat (ASC40) met all primary, key secondary, and secondary endpoints in the 480-patient randomized, double-blind, placebo-controlled Phase III clinical trial (NCT06192264) for the treatment of moderate to severe acne vulgaris (Press Release).
The mechanisms of action of denifanstat (ASC40) for the treatment of acne are (1) direct inhibition of sebum production, through inhibition of de novo lipogenesis (DNL) in human sebocytes; and (2) inhibition of inflammation, through decreasing cytokine secretion and Th17 differentiation. Denifanstat (ASC40)'s unique mechanism of action directly reduces one of the main underlying causes of acne which is the overproduction of sebum. This sets denifanstat (ASC40) apart as most other acne treatments do not treat the underlying cause of the condition.
Denifanstat(ASC40)is licensed from Sagimet Biosciences Inc. (Nasdaq: SGMT) for exclusive rights in Greater China.
About Ascletis Pharma Inc.
Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potential best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies as well as Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has developed multiple drug candidates in-house, including both small molecules and peptides, such as its lead program, ASC30, a small molecule GLP-1R agonist designed to be administered once daily orally and once monthly to once quarterly subcutaneously as a treatment therapy and a maintenance therapy for chronic weight management; ASC36, a once-monthly subcutaneously administered amylin receptor peptide agonist, ASC35, a once-monthly subcutaneously administered GLP-1R/GIPR dual peptide agonist and ASC37, a GLP-1R/GIPR/GCGR triple peptide agonist for chronic weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK). For more information, please visitwww.ascletis.com.
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