Sagimet Biosciences is preparing to begin screening patients for its US Phase 3 trial of denifanstat in moderate to severe acne, with the first enrolment expected shortly after screening begins in October.

The AURORA trial is planned to recruit approximately 800 patients aged 12 and over, including around 450 adolescents, with all clinical trial sites now identified and a contract research organisation (CRO) appointed.

Denifanstat is an oral, once-daily inhibitor of fatty acid synthase (FASN), an enzyme involved in lipid production. Sagimet is developing the drug as a potential treatment for moderate to severe acne.

AURORA will recruit 800 patients

The multi-centre, randomised, double-blind, placebo-controlled trial is expected to recruit patients over approximately six months.

Participants will be randomised in a 2:1 ratio to receive either 50mg of denifanstat or placebo once daily for 12 weeks.

The study has three co-primary endpoints at week 12. These will assess treatment success using a global assessment score, changes in inflammatory skin lesion counts and changes in non-inflammatory skin lesion counts.

Patients completing the initial 12-week treatment period will be able to enter a 40-week open-label extension to assess the long-term safety of denifanstat.

Andreas Grauer, chief medical officer at Sagimet, said: “With all the clinical trial sites identified and our CRO engaged, we are prepared to begin patient screening in October, and to enroll our first patient soon after.”

He added that the company expects to submit a New Drug Application (NDA) after completion of the 12-week phase of the study.

Denifanstat targets FASN

Denifanstat is designed to inhibit FASN, a regulator of lipid synthesis. Sagimet is investigating whether targeting the pathway can reduce the effects associated with moderate to severe acne.

The company is developing denifanstat outside China, where its licensing partner Ascletis is developing the drug as ASC40.

Previous Phase 3 research conducted by Ascletis in China found that denifanstat met the primary and secondary endpoints in a 12-week randomised, double-blind trial in moderate to severe acne vulgaris, according to Sagimet.

Sagimet also said denifanstat showed improvements in efficacy measures during a 52-week open-label Phase 3 study evaluating long-term safety.

The US AURORA trial will provide a separate assessment of denifanstat in a US patient population, with a substantial proportion of participants expected to be adolescents.

US trial follows FDA clearance

The AURORA study follows FDA clearance of Sagimet’s investigational new drug application for the Phase 3 acne programme earlier in August.

David Happel, chief executive officer of Sagimet, said the company remained on track to enrol its first patient during the fourth quarter of 2026.

“We continue to advance the clinical development of denifanstat for acne and remain on track to enroll our first patient in AURORA in the fourth quarter of 2026,” he said.

The company has not yet reported results from the US Phase 3 trial, which means the programme remains dependent on the outcome of the planned 12-week study.

If the trial meets its objectives, Sagimet expects to use the results to support an NDA submission.