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China NMPA Approves Phase II Clinical Trial of ASC40 for the Treatment of Patients with Acne

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--Phase II trial will evaluate the safety and efficacy of ASC40 in patients with moderate to severe acne

-- Phase I clinical studies indicated that sebum production was inhibited by ASC40 in a dose-dependent fashion

-- Acne is the eighth most prevalent disease in the world and affects more than 640 million people globally

--The global acne medication market size was US$11.86 billion in 2019, and is projected to reach US$13.35 billion by 2027

HANGZHOU and SHAOXING, China, Aug. 8, 2021 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX code: 1672) today announces that China National Medical Products Administration (NMPA) has approved the Phase II clinical trial application of ASC40 for the treatment of patients with moderate to severe acne.

The Phase II trial is a randomized, double-blind, placebo-controlled, multicenter clinical trial to be conducted in China to evaluate the safety and efficacy of ASC40 for the treatment of patients with moderate to severe acne vulgaris. About 180 patients are planned to be enrolled and randomly assigned to one of four cohorts (placebo, 25 mg, 50 mg, 75 mg) at the ratio of 1:1:1:1.

Acne is the eighth most prevalent disease in the world and affects more than 640 million people globally. The onset of acne often coincides with pubertal hormonal changes, and the condition affects approximately 85% of adolescents and young adults aged 12 to 25 years. However, acne can also persist into or develop during adulthood.

Current first-line treatments for acne include topical creams such as topical retinoids and androgen receptor inhibitor, oral isotretinoin, and antibiotics. A report recently published by Allied Market Research indicated that the global acne medication market size was US$11.86 billion in 2019, and is projected to reach US$13.35 billion by 2027.

Fatty acid synthase (FASN) is a key enzyme which regulates de novo lipogenesis. Human sebum production requires de novo lipogenesis, which is increased in acne and suppressed by the FASN inhibitor ASC40. Acne is the third indication approved for ASC40 clinical trials in China. The other two indications are non-alcoholic steatohepatitis (NASH) and recurrent glioblastoma (GBM).

"I am very pleased to participate as an investigator in the Phase II clinical trial of ASC40 for the treatment of patients with moderate to severe acne vulgaris," said Professor Ai'e Xu, Director of Hangzhou Institute of Dermatology. "Based on data from previous preclinical and clinical studies, I look forward to positive results from the Phase II clinical trial of ASC40, a first-in-class drug with a novel mechanism of action."

"The Phase II clinical study for moderate to severe acne is the second clinical trial with ASC40 approved by China NMPA within one month." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis. "This is the third indication for ASC40 following NASH and recurrent GBM, indicating that lipid metabolism plays an important role in multiple disease areas."

About Ascletis

Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK). Ascletis is committed to developing and commercializing innovative drugs in the areas of NASH, cancer lipid metabolism and oral checkpoint inhibitors, and viral diseases, to address unmet medical needs both in China and globally. Led by a management team with deep expertise and a proven track record, Ascletis has developed into a fully integrated platform covering the entire value chain from discovery and development to manufacturing and commercialization. Ascletis has three marketed products and a robust R&D pipeline of drug candidates.

(1) NASH: Gannex, a wholly-owned company of Ascletis, is dedicated to the R&D and commercialization of new drugs in the field of NASH. Gannex has three clinical stage drug candidates against three different targets – FASN, THR-beta and FXR, and three pre-clinical stage combination therapies. (2) Cancer lipid metabolism and oral checkpoint inhibitors: a pipeline of oral inhibitors targeting FASN, which plays a key role in cancer lipid metabolism, and a pipeline of oral PD-L1 small molecule next generation checkpoint inhibitors. (3) Viral diseases: (i) Hepatitis B: focus on breakthrough therapies for CHB clinical cure with a subcutaneously-injected PD-L1 antibody – ASC22 –and Pegasys® as cornerstone drugs. (ii) Hepatitis C: successfully launched an all-oral regimen of combining ASCLEVIR® and GANOVO® (RDV/DNV regimen). (iii) HIV/AIDS: ASC22, an immune therapy to restore HIV-specific immune responses and eventually lead to a functional cure of HIV-infected patients. For more information, please visit www.ascletis.com.

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SOURCE Ascletis Pharma Inc.