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– With first patient dosed in Phase III clinical trial, Ascletis’ strategic partner Sagimet Biosciences Inc. (“Sagimet”) advances denifanstat (ASC40)’s U.S. registrational program, building on positive Phase III clinical results in China from Ascletis
– Pivotal trial designed to enroll approximately 800 U.S. patients, including 450 adolescents aged 12 and older
– If approved, denifanstat (ASC40) has the potential to address a significant unmet need among approximately 10 million Americans with moderate to severe acne
– Ascletis’ 12-week Phase III clinical trial demonstrated that denifanstat (ASC40) was 98% and 178% more effective than U.S. Food and Drug Administration (FDA)-approved sarecycline and doxycycline with regard to placebo-adjusted percent treatment success, respectively, 18.6% for denifanstat (ASC40) versus 9.4% for sarecycline, 18.6% versus 6.7% for doxycycline
– Ascletis’ 12-week Phase III clinical trial demonstrated that denifanstat (ASC40) was 60% more effective than FDA-approved clascoterone cream with regard to placebo-adjusted percent treatment success, 18.6% for denifanstat (ASC40) versus 11.6% for clascoterone cream
HONG KONG, Oct. 23, 2026 /PRNewswire/ — Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) announced that its strategic partner, Sagimet Biosciences Inc. (“Sagimet”), a clinical-stage biopharmaceutical company developing inhibitors of fatty acid synthase (FASN), a key lipid synthesis regulator, for acne, had dosed the first patient in AURORA, Sagimet’s pivotal U.S. Phase III clinical trial of denifanstat (ASC40) in adults and adolescents aged 12 years and older with moderate to severe acne. AURORA is intended to support a potential U.S. New Drug Application (NDA) submission. The trial builds on positive Phase III clinical results and subsequent 52-week open-label extension data generated by Ascletis.
Please refer to Sagimet’s press release for more details.
Ascletis holds the rights to develop, manufacture and commercialize denifanstat (ASC40) in Greater China under an exclusive license agreement with Sagimet. Denifanstat (ASC40) is licensed from Sagimet 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 potentially 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 once-daily oral small molecule GLP-1R agonist for chronic weight management and diabetes; ASC30_48FDC, a once-daily oral small molecule dual agonist, a fixed-dose combination of ASC30 (GLP-1R agonist) and ASC48 (GIPR agonist), ASC30_48_39FDC, a once-daily oral small molecule triple agonist, a fixed-dose combination of ASC30 (GLP-1R agonist), ASC48 (GIPR agonist) and ASC39 (amylin receptor agonist (SARA)), ASC39, an eloralintide-like potent selective amylin receptor agonist (SARA) once-daily oral small molecule, ASC30_39FDC, a once-daily oral small molecule dual agonist, a fixed-dose combination of ASC30 (GLP-1R agonist) and ASC39 (amylin receptor agonist (SARA)), ASC36i, an amylin receptor peptide agonist, designed for once-monthly to once-quarterly subcutaneous administration, ASC36_35i FDC, a triple peptide agonist, a fixed-dose combination of ASC36 (amylin receptor agonist) and ASC35 (GLP-1R/GIPR agonist), designed for once-monthly to once-quarterly subcutaneous administration, ASC35i, a GLP-1R/GIPR dual peptide agonist, designed for once-monthly to once-quarterly subcutaneous administration, ASC37i, a GLP-1R/GIPR/GCGR triple peptide agonist, designed for once-monthly to once-quarterly subcutaneous administration, ASC36_37i FDC, a quadruple peptide agonist, a fixed-dose combination of ASC36 (amylin receptor agonist) and ASC37 (GLP-1R/GIPR/GCGR agonist), designed for once-monthly to once-quarterly subcutaneous administration, ASC36o, an amylin receptor peptide agonist, designed for once-weekly oral administration, ASC36_37o FDC, a quadruple peptide agonist, a fixed-dose combination of ASC36 (amylin receptor agonist) and ASC37 (GLP-1R/GIPR/GCGR agonist), designed for once-weekly oral administration, ASC36_35o FDC, a triple peptide agonist, a fixed-dose combination of ASC36 (amylin receptor agonist) and ASC35 (GLP-1R/GIPR agonist), designed for once-weekly oral administration, ASC37o, a GLP-1R/GIPR/GCGR triple peptide agonist, designed for once-weekly oral administration, ASC35o, a GLP-1R/GIPR dual peptide agonist, designed for once-weekly oral administration, for chronic weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK).
For more information, please visit www.ascletis.com.
Contact:
Peter Vozzo
ICR Healthcare
443-231-0505 (U.S.)
Peter.vozzo@icrhealthcare.com
Ascletis Pharma Inc. PR and IR Teams
+86-181-0650-9129 (China)
pr@ascletis.com
ir@ascletis.com
Source: Ascletis Pharma Inc.