Sagimet Moves Ahead with U.S. Acne Trial as Denifanstat Shows Lasting Improvement

Key Points

• Sagimet is presenting long-term results for its experimental acne pill, denifanstat, at a dermatology conference in Las Vegas.
• A study in China reported treatment success in about 57% of participants, with total acne lesions falling 72% and inflammatory lesions falling 77%.
• Some patients received denifanstat for up to 52 weeks, and the company said improvements continued with longer treatment.
• Sagimet has activated sites for its U.S. Phase 3 AURORA trial, with patient screening beginning in October.
• Denifanstat remains investigational. The long-term study did not have an ongoing placebo comparison.

Sagimet Biosciences (NASDAQ: SGMT) is advancing its U.S. Phase 3 acne trial while presenting longer-term findings from a study conducted in China by its partner, Ascletis. The company hopes denifanstat, a once-daily oral treatment, could offer a different approach to moderate to severe acne.

Longer Treatment Was Linked to Continued Acne Improvement

The long-term study included 240 patients who had completed an earlier 12-week trial. Of those, 116 had originally received denifanstat and 124 had received placebo.

During the extension, everyone received denifanstat for up to 40 additional weeks. That meant patients who took the drug from the beginning could receive up to 52 weeks of treatment, while those switching from placebo received up to 40 weeks.

Sagimet reported treatment success in approximately 57% of participants, a 72% reduction in total acne lesions and a 77% reduction in inflammatory lesions. The company said treatment was generally well tolerated and improvements continued beyond the first 12 weeks.

However, the extension mainly studied long-term safety and had no ongoing placebo group. It therefore cannot show how patients would have performed without active treatment over the same period.

Denifanstat Aims to Reduce Oil Production and Inflammation

Denifanstat blocks an enzyme called fatty acid synthase, or FASN, which is involved in making fats. Sagimet’s research suggests that blocking this enzyme can reduce the production of sebum—the oil produced by the skin—and address inflammation.

In Ascletis’ earlier 480-patient trial, denifanstat improved acne measures compared with placebo over 12 weeks, with significant improvements seen as early as four weeks.

Dr. Julie Harper is presenting the clinical and laboratory findings at the Fall Clinical Dermatology Conference, held October 8–11 at the Wynn Hotel in Las Vegas.

U.S. Phase 3 Trial Will Include Adults and Teenagers

Sagimet’s AURORA trial is expected to enroll approximately 800 U.S. patients aged 12 and older, including about 450 teenagers.

Patients will receive either denifanstat 50 mg or placebo once daily for 12 weeks. Researchers will measure whether patients achieve clear or almost-clear skin with a meaningful improvement from their starting condition, along with changes in inflammatory and non-inflammatory acne lesions.

About 530 patients who finish that portion may enter a further 40-week study to evaluate long-term safety.

Investor Takeaway: Promising Data, but U.S. Results Still Matter

For SGMT investors, the start of screening moves AURORA closer to generating the U.S. evidence needed to evaluate denifanstat. The Chinese findings provide encouraging treatment experience, but they do not guarantee that the U.S. trial will succeed.

The next milestones are patient enrollment, trial completion and results. Sagimet has not provided an AURORA results date or a regulatory filing timetable in this announcement, and denifanstat is not yet an approved acne treatment.