Key Takeaways
- Ascletis Pharma’s acne treatment denifanstat demonstrated significant efficacy in a phase 3 trial, outperforming traditional medications.
- The trial involved 480 patients with moderate to severe acne, with denifanstat achieving a 33.2% success rate compared to 14.6% for placebo.
- Denifanstat may offer a safer, more effective oral treatment option without the risks of antibiotic resistance.
Study Details and Results
Ascletis Pharma has announced a phase 3 success for its acne treatment, denifanstat, developed in partnership with Sagimet Biosciences. This oral fatty acid synthase inhibitor was tested on 480 patients suffering from moderate to severe acne vulgaris over a 12-week period. Participants were randomly assigned to receive either a 50-mg dose of denifanstat or a placebo daily.
The results were compelling, with denifanstat meeting all three primary endpoints. Notably, 33.2% of patients taking denifanstat reported clear or nearly clear skin by Week 12, contrasting sharply with the 14.6% success rate in the placebo group. Additionally, the denifanstat group observed an average reduction of 57.4% in skin lesions, compared to 35.4% for those on placebo. For inflammatory lesions specifically, reductions were 63.5% and 43.2%, respectively.
Although the trial was not primarily designed for direct comparisons with existing acne treatments, Ascletis presented its results alongside historical data for competitors. Denifanstat’s placebo-adjusted success rate of 18.6% notably outperformed those of Almirall’s Seysara (9.4%), doxycycline (6.7%), and clascoterone cream (11.6%).
Ascletis views denifanstat as a potential first-in-class, orally administered acne treatment, promising both high efficacy and improved patient adherence compared to topical alternatives. The company also indicated that denifanstat could avoid common issues associated with conventional treatments, such as antibiotic resistance and side effects linked to tetracycline antibiotics.
Regarding safety, the adverse events reported were similar between the denifanstat and placebo groups, with dry skin and dry eye being the most common side effects—affecting just over 5% of patients receiving denifanstat.
Jinzi Jason Wu, Ph.D., CEO of Ascletis, expressed satisfaction with the trial’s topline results, highlighting the drug’s considerable impact on reducing lesion counts in addition to treatment success. The company plans to submit denifanstat for approval to the China National Medical Products Administration shortly.
Ascletis acquired the rights to denifanstat from Sagimet in 2019, initially intending to explore its use for treating metabolic dysfunction-associated steatohepatitis. However, progress in this area has stagnated, with Ascletis indicating that further assessments are underway to maximize the program’s value.
The company, which originally focused on antiviral and cancer therapies, has experienced challenges in its earlier strategies, leading to a pivot towards metabolic disease solutions. This shift has included an expedited development of a weight loss pipeline featuring both oral and subcutaneous formulations of a GLP-1 receptor agonist.
As Ascletis advances its dermatology initiatives, the successful phase 3 trial positions denifanstat as a promising contender in the competitive acne treatment landscape.
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