Dosing Starts in Phase 3 ASC40 Trial For Acne Treatment

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Ascletis today announced the first patient has been dosed in its phase 3 multicenter clinical trial to evaluate the safety and efficacy of ASC40 (Denifanstat) for the treatment of moderate to severe acne vulgaris.¹

ASC40 is an oral, selective small molecule inhibitor of fatty acid synthase (FASN). According to Ascletis, the mechanisms of ASC40 for treatment of acne are: 

• direct inhibition of facial sebum production, through inhibition of de novo lipogenesis (DNL) in human sebocytes, and
• inhibition of inflammation, through decreasing cytokine secretion and Th17 differentiation.

The trial,² which is taking place in China, involves 480 subjects with moderate to severe acne randomized into 1 active treatment arm and 1 placebo control arm at the ratio of 1:1 to receive 50 mg ASC40 or matching placebo orally, once daily for 12 weeks, the company reports.

The study endpoints are:

• proportion of subjects achieving treatment success at week 12,
• percentage change from baseline in total lesion count at week 12, and
• percentage change from baseline in inflammatory lesion count (ILC) at week 12.

Treatment success is 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).

In May 2023, Ascletis announced the results of the ASC40 phase 2 clinical trial. Jinzi J. Wu, PhD, the founder, chairman and CEO of Ascletis, noted then that FASN inhibition is a novel mechanism for acne.

He stated today in a press release, “As a first-in-class drug candidate with novel mechanism for acne treatment, ASC40 has shown significant efficacy and good safety in the phase 2 study. We will accelerate the patient enrollment and expect to report the phase 3 results in the near future.”

References

1. Ascletis announces dosing of the first patient in phase III clinical trial of ASC40 (Denifanstat) for treatment of acne. News release. Ascletis. January 24, 2024. Accessed January 24, 2024.https://www.ascletis.com/news_detail/181/id/973.html

2. A study to evaluate the safety and efficacy of ASC40 (denifanstat) tablets in the treatment of patients with moderate to severe acne vulgaris.(NCT06192264). ClincalTrials.gov. Updated January 5, 2024. Accessed January 24, 2024. https://classic.clinicaltrials.gov/ct2/show/NCT06192264