Ascletis Pharma has announced positive results from its Phase 3 clinical trial evaluating denifanstat, an oral fatty acid synthase (FASN) inhibitor, for the treatment of moderate to severe acne vulgaris. The trial met all primary endpoints, showcasing the drug's potential as a first-in-class oral therapy for acne.

The randomized, double-blind, placebo-controlled, multicenter study enrolled 480 patients in China. Participants received either a 50 mg daily dose of denifanstat or a placebo over 12 weeks. Results indicated that 33.2% of patients in the denifanstat group achieved treatment success, defined as clear or almost clear skin, compared to 14.6% in the placebo group.

Denifanstat also demonstrated significant reductions in skin lesions. Patients treated with the drug experienced a 57.4% decrease in total lesion count and a 63.5% reduction in inflammatory lesions, outperforming the placebo group's 35.4% and 43.2% reductions, respectively.

The safety profile of denifanstat was favorable, with adverse events comparable between the treatment and placebo groups. The most common treatment-related side effects were dry skin and dry eye, each affecting slightly more than 5% of patients in the denifanstat arm.

Denifanstat operates by inhibiting FASN, an enzyme involved in de novo lipogenesis, thereby reducing sebum production and inflammation-key factors in acne pathogenesis.^[1] This novel mechanism offers an alternative to traditional antibiotics and topical treatments, potentially improving patient compliance and addressing antibiotic resistance concerns. This approach could be particularly impactful in addressing rising global concerns about antibiotic resistance in dermatological care. Denifanstat's unique FASN inhibition pathway bypasses the microbial resistance issue, making it a promising long-term solution for chronic acne sufferers. Moreover, the convenience of a once-daily oral pill could significantly enhance patient adherence compared to multi-step topical regimens.

Ascletis plans to submit denifanstat for regulatory approval in China, aiming to provide a new oral treatment option for individuals with moderate to severe acne. The company believes that denifanstat's efficacy and safety profile position it favorably against existing therapies like Seysara and doxycycline.

References:

1. ClinicalTrials.gov. (2024). A study to evaluate the safety and efficacy of ASC40 (Denifanstat) tablets in the treatment of patients with moderate to severe acne vulgaris (NCT06192264).(2024).

(Input from various sources)

(Rehash/Sakshi Thakar/MSM)