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Ascletis Completes Phase III Enrollment of Denifanstat for Moderate to Severe Acne

• Ascletis Pharma has completed enrollment of 480 patients in its Phase III clinical trial for denifanstat (ASC40), an oral tablet for moderate to severe acne. • The Phase III trial is a randomized, double-blind, placebo-controlled, multicenter study evaluating the safety and efficacy of once-daily oral denifanstat. • Topline results from the Phase III trial are anticipated in the second quarter of 2025, building on positive Phase II results. • Denifanstat is a first-in-class, once-daily oral inhibitor of fatty acid synthase (FASN) with a novel mechanism for acne treatment.

Ascletis Pharma Inc. has announced the completion of enrollment for its Phase III clinical trial of ASC40 (denifanstat), a once-daily oral tablet being investigated for the treatment of moderate to severe acne. The trial, which enrolled a total of 480 patients, is a randomized, double-blind, placebo-controlled, multicenter study conducted in China.
The trial aims to evaluate the safety and efficacy of ASC40, with patients randomized in a 1:1 ratio to receive either 50 mg of ASC40 or a matching placebo once daily for 12 weeks. The first patient was enrolled on January 24, 2024, and topline results are expected in the second quarter of 2025.

Trial Design and Endpoints

The primary efficacy endpoints of the Phase III trial include:
  • The proportion of patients achieving treatment success at week 12, defined as at least a 2-point reduction in Investigator's Global Assessment (IGA) score from baseline and a score of clear (0) or almost clear (1).
  • The percentage change from baseline in total lesion count at week 12.
  • The percentage change from baseline in inflammatory lesion count at week 12.

Mechanism of Action

ASC40 (denifanstat) is a first-in-class, once-daily oral, selective small molecule inhibitor of fatty acid synthase (FASN). Its mechanisms of action for acne treatment include:
  1. Direct inhibition of facial sebum production through inhibition of de novo lipogenesis (DNL) in human sebocytes.
  2. Inhibition of inflammation through decreasing cytokine secretion and Th17 differentiation.
ASC40 is licensed from Sagimet Biosciences Inc. for exclusive rights in Greater China.

Prior Phase II Results

Ascletis previously announced positive results from a Phase II clinical trial of ASC40, where the drug met its primary and key secondary endpoints. The Phase II trial demonstrated superior efficacy, with 19.4% of patients achieving treatment success at week 12 compared to 5.1% in the placebo group. The drug also exhibited a good safety profile.

Executive Commentary

"As a first-in-class once-daily oral drug candidate with a novel mechanism for acne treatment, ASC40 has shown positive efficacy and a good safety profile in the Phase II study," said Dr. Jinzi J. Wu, Founder, Chairman, and CEO of Ascletis. "We look forward to announcing topline results of the ASC40 (denifanstat) Phase III trial in the second quarter 2025."
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Ascletis Completes Enrollment in Phase III Trial of Denifanstat for Acne

Ascletis Pharma has completed enrollment of 480 patients in a Phase III clinical trial for ASC40 (denifanstat), an oral tablet for moderate to severe acne.
The trial is a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of once-daily ASC40 over 12 weeks.

Ascletis Completes Enrollment in Phase III Trial of Denifanstat for Moderate to Severe Acne

Ascletis Pharma has completed enrollment of 480 patients in its Phase III clinical trial for ASC40 (denifanstat), an oral tablet for moderate to severe acne.
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Reference News

[1]
Ascletis Completes Phase 3 Enrollment for Novel Acne Drug, Building on Phase 2 Success
stocktitan.net · Nov 12, 2024

Ascletis Pharma completes enrollment of 480 patients for Phase III trial of ASC40 oral tablet for moderate to severe acn...

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