Ascletis Unveils Promising Phase III Results for Acne Treatment at EADV Congress
Ascletis Unveils Promising Phase III Results for Acne Treatment at EADV Congress
In a significant development for dermatology, Ascletis Pharma Inc. recently presented the outcomes of its Phase III clinical trial for Denifanstat (ASC40) at the European Academy of Dermatology and Venereology (EADV) Congress 2025 held in Paris, France. This trial assessed the efficacy of Denifanstat in treating moderate to severe acne vulgaris and established it as a first-in-class FASN inhibitor.
Study Overview
The Phase III trial was adeptly designed as a randomized, double-blind, placebo-controlled study, enrolling 480 patients across multiple centers in China. Participants were evenly split into two groups: one receiving Denifanstat (ASC40) at a dosage of 50 mg once daily and the other receiving a placebo for a duration of 12 weeks. The well-balanced characteristics between the two groups validated the reliability of the trial outcomes, showcasing Denifanstat's potential to tackle the challenges of acne treatment effectively.
Efficacy Results
Denifanstat (ASC40) met all primary, key secondary, and additional secondary efficacy endpoints as per the intention-to-treat (ITT) analysis. Most notably, after just four weeks of treatment, the Denifanstat group exhibited notable improvements over the placebo group in various efficacy endpoints, including treatment success, total lesion count (TLC), inflammatory lesion count (ILC), and non-inflammatory lesion count (NILC).
The statistically significant differences were prominent after the complete 12-week treatment phase, as detailed in the efficacy results (Table 1).
Table 1. Efficacy results from the Phase III study versus placebo
| Efficacy Endpoints | Denifanstat (ASC40) | Placebo | Placebo-adjusted | P value |
|---|---|---|---|---|
| ---- | ---- | -- | ---- | ---- |
| Percent treatment success | 33.17% | 14.58% | 18.59% | <0.0001 |
| Percent reduction in TLC | 57.38% | 35.42% | 21.96% | <0.0001 |
| Percent reduction in ILC | 63.45% | 43.21% | 20.24% | <0.0001 |
| Percent reduction in NILC | 51.85% | 28.94% | 22.91% | <0.0001 |
| Absolute reduction in TLC | 58.25 | 36.17 | 22.08 | <0.0001 |
| Absolute reduction in ILC | 26.56 | 18.42 | 8.14 | <0.0001 |
Denifanstat represents a notable advancement in acne treatment, offering a new mechanism of action that was well-received within the dermatology community during its presentation. Feedback from attendees suggested a strong interest in the drug, given its capacity to address a condition affecting millions worldwide.
Safety Profile
In addition to its efficacy, Denifanstat (ASC40) displayed a favorable safety and tolerability profile. The rates of treatment-emergent adverse events (TEAEs) were comparable between the Denifanstat group (58.6%) and placebo (56.3%), with most events categorized as mild or moderate. Notably, only two TEAEs reported incidences above 5%: dry skin and xerophthalmia.
Most importantly, there were no severe or grade 3/4 TEAEs associated with Denifanstat, indicating a generally strong safety profile that enhances the drug's appeal for widespread adoption in acne treatment.
Future Directions
The results presented at the EADV Congress 2025 align with Ascletis' proactive approach, as the company is actively engaged in pre-New Drug Application (NDA) consultations with the China National Medical Products Administration (NMPA). The ongoing interaction has yielded positive feedback, providing a robust foundation for Ascletis to initiate an NDA submission for Denifanstat's approval once the consultations conclude.
Dr. Jinzi Jason Wu, CEO of Ascletis, expressed enthusiasm regarding the findings, emphasizing that Denifanstat's innovative mechanism and its significant improvements over placebo in the study reinforce its potential as a leading treatment option for acne vulgaris.
In conclusion, Ascletis’ Denifanstat (ASC40) marks an exciting advancement in the dermatological field, offering new hope to millions of individuals struggling with moderate to severe acne. The company’s commitment to bringing this product to market demonstrates its ongoing dedication to addressing unmet medical needs within the sector.
Topics Health）
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