Ascletis’ Sagimet-Sourced Oral FASN Inhibitor Achieves All Endpoints in Pivotal Acne Study

Ascletis Pharma's oral fatty acid synthase (FASN) inhibitor, denifanstat, sourced from Sagimet Biosciences, met all primary endpoints in a phase 3 trial for moderate to severe acne vulgaris in China14.

The randomized, placebo-controlled trial enrolled 480 patients who received either a once-daily 50 mg dose of denifanstat or placebo over 12 weeks14.

33.2% of patients in the denifanstat group achieved clear or almost clear skin (IGA 0 or 1 with >=2-point improvement) after 12 weeks, compared to 14.6% in the placebo group—a significant difference14.

Denifanstat showed a 57.4% reduction in total lesion count versus 35.4% for placebo; inflammatory lesions were reduced by 63.5% compared to 43.2% with placebo14.

For non-inflammatory lesions, denifanstat led to a 51.9% reduction, outperforming placebo’s 28.9%34.

The drug’s placebo-adjusted treatment success rate (18.6%) compares favorably to FDA-approved products like Seysara (9.4%), doxycycline (6.7%), and clascoterone cream (11.6%), though no direct head-to-head comparisons were performed1.

No deaths were reported during the trial, and the results support FASN inhibition as a novel therapeutic approach for acne2.

Sources:

1. https://www.fiercebiotech.com/biotech/ascletis-scores-phase-3-win-daily-acne-pill-prepares-push-chinese-regulators

2. https://ir.sagimet.com/news-releases/news-release-details/sagimet-biosciences-announces-positive-phase-3-results

3. https://firstwordpharma.com/story/5968563

4. https://www.dermatologytimes.com/view/denifanstat-hits-all-targets-in-chinese-study