Ascletis Begins Phase III Trial for ASC40 Acne Treatment

Ascletis Pharma, a biotech firm listed on the Hong Kong Stock Exchange, has initiated a Phase III clinical trial for its acne treatment drug, ASC40, also known as Denifanstat. The trial, which is taking place at Huashan Hospital affiliated with Fudan University, is designed to assess the safety and effectiveness of the medication for individuals suffering from moderate to severe acne vulgaris.

The study is structured as a randomized, double-blind, and placebo-controlled multicenter trial across China. It plans to enroll 480 participants who will be evenly divided into two groups: one receiving the active drug and the other a placebo. Both groups will take their respective treatments orally once daily for a period of 12 weeks.

The trial's primary goals are to measure the proportion of participants who achieve a successful treatment outcome by the 12-week mark, the overall reduction in lesion count from the start of the study, and the specific reduction in the count of inflammatory lesions. Success in treatment is gauged by a minimum decrease of two points in the Investigator's Global Assessment (IGA) score, along with achieving a score indicating clear (0) or almost clear (1) skin.

Previously, on May 2, 2023, Ascletis reported that ASC40 had met its primary and key secondary objectives in Phase II trials, showcasing its superior efficacy and safety profile. ASC40 functions as an oral, selective inhibitor of fatty acid synthase (FASN), targeting acne through two main mechanisms: reducing facial sebum production by inhibiting de novo lipogenesis in sebocytes and curbing inflammation by lowering cytokine secretion and Th17 cell differentiation.

Ascletis possesses the exclusive rights to develop, manufacture, and market ASC40 in Greater China, licensed from Sagimet Biosciences Inc. The company's leadership, under the guidance of Dr. Jinzi J. Wu, Founder, Chairman, and CEO, has reiterated their commitment to advancing this promising treatment. ASC40 is positioned as a first-in-class drug with a novel mechanism for treating acne, and following the positive Phase II results, the company is expediting patient enrollment with the anticipation of revealing Phase III outcomes shortly.

Ascletis is recognized for its innovative research and development, covering every aspect of the biotech industry from discovery to commercialization. With a dedicated management team and a robust track record, the company is dedicated to addressing unmet needs in viral diseases, non-alcoholic steatohepatitis (NASH), and oncology. Ascletis continues to make strides in its drug development pipeline, aiming to be at the forefront of global competition, with several drug candidates in various stages of research and development.