Chinese NMPA Approves ASC40 Phase II Clinical Trial for Treatment of Acne Patients

–Phase II trial will evaluate the safety and efficacy of AUC40 in patients with moderate to severe acne

– Phase I clinical studies indicated that sebum production was inhibited by AUC40 in a dose-dependent manner

– Acne is the eighth most common disease in the world and affects more than 640 million people worldwide

–The global acne drugs market size was 11.86 billion US dollars in 2019, and is expected to reach $ 13.35 billion by 2027

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

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

Acne is the eighth most common disease in the world and affects more than 640 million people worldwide. The onset of acne often coincides with puberty hormonal changes, and the disease affects about 85% of adolescents and young adults between the ages of 12 and 25. However, acne can also persist or develop into adulthood.

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

Fatty acid synthase (FASN) is a key enzyme that regulates lipogenesis de novo. The production of human sebum requires de novo lipogenesis, which is increased in acne and suppressed by the FASN inhibitor ASC40. Acne is the third indication approved for clinical trials ASC40 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 the positive results of the Phase II clinical trial of ASC40, a first-class drug with a novel mechanism of action.

“The Phase II clinical study for moderate to severe acne is the second Chinese NMPA-approved clinical trial with ASC40 in one month.” said dr. Jinzi J. Wu, founder, Chairman and CEO of Ascletis. “This is the third indication for AUC40 after NASH and recurrent GBM, indicating that lipid metabolism plays an important role in several disease areas.”

About Ascletis

Ascletis is an innovative R&D-driven biotechnology 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 proven track record, Ascletis has grown into a fully integrated platform spanning the entire value chain, from discovery and development to manufacturing and marketing. Ascletis has three products on the market and a solid R&D pipeline of drug candidates.

(1) NASH: Gannex, a company 100% owned by Ascletis, is dedicated to the R&D and commercialization of new drugs in the field of NASH. Gannex has three drug candidates in the clinical stage against three different targets – FASN, THR-beta and FXR, and three combination therapies in the preclinical stage. (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 next-generation checkpoint inhibitors small molecule PD-L1. (3) Viral diseases: (i) Hepatitis B: focus on revolutionary therapies for the clinical cure of CHB with a PD-L1 antibody injected subcutaneously – ASC22 – and Pegasys® as basic drugs. (ii) Hepatitis C: successful launch of an all-oral ASCLEVIR combination regimen® and GANOVO® (RDV / DNV scheme). (iii) HIV / AIDS: ASC22, an immune therapy to restore immune responses specific to HIV and possibly lead to a functional cure in patients infected with HIV. For more information, please visit www.ascletis.com.

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SOURCE Ascletis Pharma Inc.

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