Ascletis Pharma Inc. Achieves Breakthrough in Acne Treatment with Denifanstat
In a significant development for the biotechnology sector, Ascletis Pharma Inc., a leading company specializing in antiviral, cancer, and fatty liver disease treatments, has announced a major breakthrough in acne therapeutics. The company’s Phase III clinical trial for denifanstat (ASC40), a first-in-class, once-daily oral fatty acid synthase (FASN) inhibitor, has met all primary, key secondary, and secondary endpoints, marking a potential game-changer in the treatment of moderate to severe acne vulgaris.
Impressive Efficacy and Safety Profile
The trial results, announced on June 3, 2025, reveal that denifanstat demonstrated statistically significant and clinically meaningful improvements over placebo in all measured endpoints. Notably, denifanstat was found to be 98% and 178% more effective than FDA-approved sarecycline and doxycycline, respectively, in terms of placebo-adjusted percent treatment success. Additionally, it outperformed FDA-approved clascoterone cream by 60%, showcasing its superior efficacy.
Beyond its effectiveness, denifanstat also exhibited a favorable safety and tolerability profile. The treatment was associated with mild to moderate adverse events, including dry skin (6.3%) and dry eye (5.9%), with no serious adverse events or severe side effects reported. This safety profile, coupled with its efficacy, positions denifanstat as a promising new option for acne treatment.
A Novel Approach to Acne Treatment
One of the most compelling aspects of denifanstat is its unique mechanism of action. By targeting the root cause of acne through FASN inhibition, denifanstat offers a novel approach compared to existing treatments. This mechanism not only contributes to its efficacy but also addresses the issue of antibiotic resistance, a growing concern with current acne treatments. Furthermore, as an oral therapy, denifanstat presents better potential treatment adherence compared to topical therapies, which suffer from a 30-40% non-adherence rate.
Looking Ahead
While the Phase III trial results are promising, it’s important to note that the study was conducted solely in China. Additional studies may be required for global approval. However, the exceptional efficacy and safety profile of denifanstat, as demonstrated in the trial, provide a strong foundation for its potential as a major breakthrough in acne treatment.
Ascletis Pharma Inc., listed on the Hong Kong Stock Exchange with a market cap of 6.84 billion HKD, continues to demonstrate its commitment to addressing unmet medical needs through innovative drug development. With denifanstat’s successful trial results, Ascletis is poised to make a significant impact on the global healthcare landscape, offering new hope to individuals suffering from moderate to severe acne vulgaris.
As the biotechnology industry watches closely, Ascletis Pharma Inc.’s achievement with denifanstat underscores the company’s role as a leader in developing groundbreaking treatments that address critical healthcare challenges.