HANGZHOU and SHAOXING, China, March 10, 2024 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") today announces the poster presentation of Phase II study final results of ASC40, a first-in-class fatty acid synthase (FASN) inhibitor for treatment of acne, at the 2024 American Academy of Dermatology (AAD) Annual Meeting in San Diego, the United States.

The summary of the poster is shown as below:

Title:

First FASN inhibitor ASC40 to treat acne vulgaris patients: final results from a Phase 2 trial

Method:

This phase 2 trial (NCT05104125) was a randomized, double-blind, placebo-controlled, multicenter study. 180 patients were 1:1:1:1 assigned to the ASC40 25\50\75 mg or placebo QD for 12-week treatment and 2-week follow-up. Efficacy and safety of ASC40 vs placebo were assessed.

Background:

ASC40 (denifanstat) is a potent and selective small molecule inhibitor of fatty acid synthase (FASN). Mechanisms of action of ASC40 for acne treatment are novel: (1) direct inhibition of facial sebum production through inhibition of de novo lipogenesis (DNL) in sebocytes; and (2) inhibition of inflammation through decreasing cytokine secretion. Previous clinical studies showed that ASC40 treatment for 10 days reduced significantly facial sebum palmitic acid levels. Here we report the efficacy and safety results from a phase 2 study of ASC40 in patients with moderate to severe acne vulgaris after 12-week treatment.

Results:

At week 2, 4, 8 and 12, percentage and absolute change from baseline in total lesion, inflammatory and non-inflammatory lesion counts as well as treatment success and Investigator's Global Assessment (IGA) reduction ≥ 2 were assessed. At all doses, above efficacy measures generally improved from week 2 to week 12. 50 mg QD demonstrated the best efficacy: placebo-adjusted proportion of patients with treatment success and IGA reduction ≥ 2 were 14.3% and 16.2%, respectively. Placebo-adjusted median percentage (absolute) change from baseline in total lesion and inflammatory counts were -27.1% (-23.5) and -33.5% (-13), respectively (p = 0.008 (0.030) and 0.003 (0.003)).

Safety:

The incidence rates of study drug related AEs were comparable among 25 mg (grade 1 = 28.9%; grade 2 = 20.0%), 50mg (grade 1 = 36.4%; grade 2 = 11.4%), 75 mg (grade 1 = 44.4%; grade 2 = 17.8%) ASC40 and placebo (grade 1 = 35.6%; grade 2 = 13.3%). The most common study drug related AE was dry eyes whose incidence rates were similar among 25 mg (grade 1 =17.8%; grade 2 = 6.6%), 50 mg (grade 1 = 22.7%; grade 2 = 2.3%), 75 mg (grade 1 = 15.5%; grade 2 =11.1%) ASC40 and placebo (grade 1 = 28.9%; grade 2 = 6.6%). There were no clinically significant findings in clinical laboratory, vital signs and electrocardiography. There were no ASC40 related grade 3 or 4 AEs and no ASC40 related serious AEs (SAEs).