Sagimet Biosciences Announces First Patient Dosed in AURORA Phase 3 U.S. Clinical Trial of Denifanstat for Moderate to Severe Acne
Key Highlights
- ➤Sagimet (SGMT) doses first patient in pivotal U.S. AURORA Phase 3 acne trial
- ➤AURORA plans approximately 800 patients, including 450 adolescents aged 12 and older
- ➤Topline AURORA results expected in the second half of 2027
- ➤Ascletis Phase 3 denifanstat trial met all primary and secondary endpoints in China
Expert Statements
David Happel, Chief Executive Officer of Sagimet
“Dosing the first patient in our AURORA Phase 3 clinical trial marks a significant milestone for Sagimet”
David Happel, Chief Executive Officer of Sagimet
“Our focus is on advancing this registrational trial, with topline results expected in the second half of 2027. If approved, denifanstat would be the first once-daily oral acne treatment with a novel mechanism of action approved by the FDA for the treatment of acne in more than 40 years, offering a new treatment option for the approximately 10 million U.S. patients living with moderate to severe acne.”
Andreas Grauer, Chief Medical Officer of Sagimet
“As well as the positive Phase 3 data generated by our license partner Ascletis, Sagimet’s mechanistic non-clinical and clinical data provide further support for denifanstat’s differentiated approach to targeting sebum production and inflammation, key drivers of acne”
Andreas Grauer, Chief Medical Officer of Sagimet
“We look forward to conducting our registrational Phase 3 clinical trial and bringing denifanstat to patients and their families who we feel are currently underserved by the available treatment options.”
* With first patient dosed in AURORA Phase 3 clinical trial, Sagimet advances denifanstat's U.S. registrational program, building on positive Phase 3 clinical results in China from license partner Ascletis * Pivotal trial designed to enroll approximately 800 U.S. patients, including 450 adolescents aged 12 and older * If approved, denifanstat has the potential to address a significant unmet need among approximately 10 million Americans with moderate to severe acne FOSTER CITY, Calif., Oct. 22, 2026 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing inhibitors of fatty acid synthase (FASN), a key lipid synthesis regulator, for acne, today announced that the first patient has been dosed in AURORA, its pivotal U.S. Phase 3 clinical trial of denifanstat 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 3 clinical results and subsequent 52-week open-label extension data generated by Sagimet’s license partner Ascletis BioScience Co. Ltd. (Ascletis) in China. Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor being developed by Ascletis as ASC40 in China where it holds an exclusive license to denifanstat, and by Sagimet in the rest of the world.
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