US EditionAscletis Announces Phase III Trial of Denifanstat (ASC40), a First-in-Class, Once-Daily Oral FASN Inhibitor for Acne, Meets All Endpoints
- Ascletis Pharma announced on June 3, 2025 in Hong Kong that its Phase III trial showed denifanstat significantly improved moderate to severe acne outcomes in 480 patients across China.
- The Phase III study employed a randomized assignment with both participants and investigators blinded to treatment, comparing once-daily 50 mg denifanstat tablets to a matching inactive control over 12 weeks to assess safety and effectiveness.
- Denifanstat targets fatty acid synthase, addressing a key acne cause and demonstrated statistically significant improvements in all primary and secondary endpoints compared to placebo.
- At week 12, active patients showed 33.2% treatment success versus 14.6% placebo, 57.4% total lesion count reduction versus 35.4% placebo, all with p-values less than 0.0001.
- Denifanstat was well tolerated, showing adverse event rates similar to placebo with no severe drug-related issues, and the company plans to submit the treatment for regulatory approval in China in the near future.
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Ascletis Announces Phase III Trial of Denifanstat (ASC40), a First-in-Class, Once-Daily Oral FASN Inhibitor for Acne, Meets All Endpoints
Denifanstat (ASC40), a once-daily oral fatty acid synthase (FASN) inhibitor, demonstrated statistically significant and clinically meaningful improvement compared to placebo in all primary, key secondary, and secondary endpointsDenifanstat demonstrated a favorable safety and tolerability profileDenifanstat was 98% and 178% more…
Sagimet's stock rises after China partner reports positive Phase 3 trial in acne
Sagimet Biosciences' FASN inhibitor denifanstat succeeded in a China-based Phase 3 trial in moderate-to-severe acne that was run by its local partner Ascletis. While that trial is for the Chinese market and won't be used ...
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