Ascletis Announces Initiation of Phase III Clinical Trial of ASC40 (Denifanstat) for Treatment of Acne

--The Phase III clinical trial of ASC40 for moderate to severe acne vulgaris will enroll 480 subjects

--The protocol of Phase III clinical trial has been agreed by Center for Drug Evaluation, National Medical Products Administration and obtained the approval from Institutional Review Board of Huashan Hospital, Fudan University

--Professor Leihong Xiang of Huashan Hospital, Fudan University, serves as the principal investigator of this Phase III clinical trial

HANGZHOU and SHAOXING, China, Dec. 5, 2023 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") today announces initiation of the Phase III clinical trial of fatty acid synthase (FASN) inhibitor ASC40 (Denifanstat) for treatment of moderate to severe acne vulgaris.

This Phase III clinical trial is a randomized, double-blind, placebo-controlled, multicenter clinical trial in China to evaluate the safety and efficacy of ASC40 for the treatment of moderate to severe acne vulgaris. 480 subjects with moderate to severe acne vulgaris will be enrolled and randomized into one active treatment arm and one placebo control arm at the ratio of 1:1 to receive 50 mg ASC40 or matching placebo orally, once daily for 12 weeks.

The co-primary efficacy endpoints are: proportion of subjects achieving treatment success at week 12, percentage change from baseline in total lesion count, and percentage change from baseline in inflammatory lesion count (ILC) at week 12. Treatment success is defined as at least a 2-point reduction in Investigator's Global Assessment (IGA) score from baseline and a score of clear (0) or almost clear (1).

The protocol of Phase III clinical trial has been agreed by Center for Drug Evaluation, National Medical Products Administration and obtained the approval from Institutional Review Board of Huashan Hospital, Fudan University.

On May 2, 2023, Ascletis announced that ASC40 achieved primary and key secondary endpoints in the Phase II clinical trial for the treatment of acne vulgaris, demonstrating superior efficacy and good safety.

ASC40 is an oral, selective small molecule inhibitor of FASN. Mechanisms of ASC40 for treatment of acne are (1) direct inhibition of facial sebum production, through inhibition of de novo lipogenesis (DNL) in human sebocytes; and (2) inhibition of inflammation, through decreasing cytokine secretion and Th17 differentiation. Ascletis holds the rights to develop, manufacture and commercialize ASC40 in Greater China under an exclusive license from Sagimet Biosciences Inc.

Acne is the eighth most prevalent disease in the world and affects more than 640 million people globally ^[1]. Adherence to topical therapies is worse when compared with that for oral agents: an estimated 30% to 40% of patients do not adhere to their topical treatments ^[2]. Currently, effective oral treatment for acne are mainly isotretinoin which can cause a lot of severe adverse events such as hepatotoxicy, hearing impairment and depression, etc. ASC40 has the potential to be a first-in-class, once-daily oral acne therapeutic with high patient compliance.

"There has been a lack of new drugs on the market for acne treatment. ASC40 is an oral drug candidate with a novel mechanism of action for acne treatment." Professor Leihong Xiang, Chief Physician of Dermatological Department, Huashan Hospital, Fudan University, Executive Deputy Director of Institute of Dermatology, Fudan University, Deputy Director of Dermatology Division of Chinese Medical Doctor Association and principal investigator (PI) of ASC40 Phase III clinical trial for moderate to severe acne.

"I'm glad that Ascleits has achieved another milestone, which reflects our strong execution to advance our pipeline programs into late-stage clinical development. As a first-in-class drug candidate with novel mechanism for acne treatment, ASC40 has demonstrated significant efficacy and good safety in the Phase II study. We believe that the novel mechanism of action will translate ASC40 into a safe and effective treatment for moderate to severe acne treatment." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis.

About Ascletis

Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), covering the entire value chain from discovery and development to manufacturing and commercialization. Led by a management team with deep expertise and a proven track record, Ascletis focuses on three therapeutic areas with unmet medical needs from a global perspective: viral diseases, non-alcoholic steatohepatitis (NASH) and oncology. Through excellent execution, Ascletis rapidly advances its drug pipeline with an aim of leading in global competition. To date, Ascletis has multiple drug candidates in its R&D pipeline. The most advanced drug candidates include ASC22 (CHB functional cure), ASC40 (acne), ASC40 (recurrent glioblastoma), ASC40 (NASH), ASC41 (NASH) and ASC61 (advanced solid tumors).

For more information, please visit www.ascletis.com.