Clinical trials of Ascletis' ASC40 FASN inhibitor, scheduled for 2025, demonstrate a reduction in acne lesions by half.
In a significant development for the treatment of acne, Ascletis Pharma Inc. has announced the results of a Phase III clinical trial for denifanstat (ASC40). The trial, a randomized, double-blind, placebo-controlled, multicenter study conducted in China, involved 480 patients with moderate to severe acne.
The Principal Investigator of the study, Dr. Leihong (Flora) Xiang, M.D., Ph.D., from the Department of Dermatology at Huashan Hospital, Fudan University, presented the findings at the European Academy of Dermatology and Venereology Congress 2025. The oral presentation was titled "First-in-Class FASN Inhibitor Denifanstat Achieved All Endpoints in the Treatment of Acne."
Denifanstat demonstrated a favorable safety and tolerability profile following 12 weeks of once-daily oral administration at 50 mg. All denifanstat-related treatment-emergent adverse events (TEAEs) were mild (Grade 1) or moderate (Grade 2). No denifanstat-related permanent treatment discontinuations or withdrawals were observed, and no deaths were reported.
After 12-week treatment, denifanstat met all primary, key secondary, and secondary efficacy endpoints. The primary endpoints of the trial included the percent treatment success, defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease in IGA from baseline at week 12, the percent reductions from baseline to week 12 in total lesion count (TLC), and the percent reduction from baseline to week 12 in inflammatory lesion count (ILC).
After 4-week treatment, the denifanstat group showed statistically significant improvements over placebo in multiple efficacy endpoints, including treatment success, TLC, ILC, and non-inflammatory lesion count (NILC).
Two categories of TEAEs had an incidence rate of more than 5%: dry skin and xerophthalmia. No incidence rates of TEAEs related to study drug in any category exceeded 10%.
Ascletis plans to submit an NDA for denifanstat for the treatment of moderate to severe acne to NMPA after completing its pre-NDA consultation. Table 1 summarizes efficacy results from the Phase III study versus placebo (intent-to-treat, ITT analysis).
This promising development could pave the way for a new treatment option for patients with moderate to severe acne. Further research and regulatory approvals are expected before denifanstat becomes available for clinical use.
Read also:
- Trump's SNAP reductions and New York City Council's grocery delivery legislation: Problems for city residents highlighted
- Reducing dental expenses for elderlies in Sweden: Over 50% cut in charges for pensioners by the government
- Forty-year-old diet: A list of meal choices to savor
- Exiled Life's Conundrum: A Blend of Liberation, Disillusionment, and Distress
