ASCLETIS (01672.HK): Denifanstat US phase III doses first patient
- Denifanstat is a FASN inhibitor, and Ascletis holds exclusive Greater China rights to develop, manufacture and commercialise it.
- Its placebo-adjusted 18.6% success rate was 98% higher than sarecycline, 178% higher than doxycycline and 60% higher than clascoterone cream.
NewTimeSpace News: On 23 October 2026, Ascletis Pharma Inc. (stock code: 01672) said its strategic partner Sagimet Biosciences Inc. has dosed the first patient in AURORA, a pivotal US phase III trial of denifanstat (ASC40) in adults and adolescents with moderate-to-severe acne. The trial plans to enrol about 800 US patients, including 450 adolescents aged 12 and over, to support a potential US new drug application.
The trial builds on positive phase III results in China and 52-week open-label extension data. In Ascletis's 12-week phase III study, denifanstat's placebo-adjusted 18.6% treatment success rate was 98% higher than sarecycline (9.4%), 178% higher than doxycycline (6.7%), both FDA-approved, and 60% higher than clascoterone cream (11.6%). Ascletis holds exclusive Greater China rights to develop, manufacture and commercialise denifanstat. Under Rule 18A.05, the Company warned it cannot guarantee successful development, sales or commercialisation.
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