Ascletis announces that 180 patients have been enrolled in the Phase II clinical trial of ASC40 for the treatment of moderate to severe acne

As of now, approximately 50% of enrolled patients have completed 12 weeks of treatment, and all enrolled patients are expected to complete 12 weeks of treatment by the end of February 2023

The clinical efficacy observed in patients who had completed 12 weeks of treatment with ASC40 or placebo was similar to that of WINLEVI® and TWYNEO,® two acne drugs approved by the U.S. FDA

In a previous phase II clinical trial for patients with nonalcoholic steatohepatitis (NASH), 61% of patients with 50 mg of ASC40 were given once daily for 12 weeks, resulting in a ≥30% reduction in liver fat

On November 30, 2022, Ascletis WeChat public account announced that 180 patients have been enrolled in the phase II clinical trial of ASC40 (denifanstat) for the treatment of moderate to severe acne. The study is currently unblinded.

To date, approximately 50% of enrolled patients have completed 12 weeks of treatment, and all enrolled patients are expected to complete 12 weeks of treatment by the end of February 2023. The clinical efficacy observed in patients who have completed 12 weeks of ASC 40 or placebo is similar to that of WINLEVI® and TWYNEO, two acne drugs approved by the U.S. Food and Drug Administration in terms of percentage change in total lesion count from baseline and percentage change in inflammatory and non-inflammatory lesion count from baseline [1,2®]. To date, preliminary data also show that ASC40 or placebo is well tolerated in patients, with most treatment-related adverse events being grade 1. In a previous phase II clinical trial for the treatment of patients with nonalcoholic steatohepatitis (NASH), liver fat was reduced by ≥30 percent in 61 percent of patients after 50 mg of ASC40 once daily for 12 weeks [3].

The current Phase II study is a randomized, double-blind, placebo-controlled, multicenter clinical trial conducted in China to evaluate the safety and efficacy of ASC40 in the treatment of patients with moderate to severe acne. The 180 enrolled patients were randomized to three active drug groups and one placebo control group in a 1:1:1 ratio and received oral ASC 40 (25 mg, 50 mg, or 75 mg) once daily or placebo for 12 weeks. Primary measures included percentage change in total lesion count from baseline at week 12 of treatment and/or proportion of participants with a ≥2 point reduction in investigators' overall static score (IGA) from baseline at week 12 of treatment.

ASC40 is a selective oral small molecule inhibitor of fatty acid synthase (FASN), a key enzyme in the de novo (DNL) pathway. Sebum secretion depends on de novo synthesis of fatty acids, which increases during acne formation, while the FASN inhibitor ASC40 inhibits sebum secretion.

Acne is the eighth most prevalent disease in the world, with more than 640 million people living with acne worldwide [4]. The onset of acne is often associated with hormonal changes during puberty, and affects approximately 85 percent of adolescents aged 12 to 25 years [5]. However, acne can also persist into adulthood or develop into adulthood. Current first-line medications for acne include topical creams such as tretinoins, androgen receptor inhibitors, oral isotretinoin, and antibiotics, but there are several limitations.

Professor Xiang Leihong, Chief Physician of the Department of Dermatology, Huashan Hospital Affiliated to Fudan University, Executive Deputy Director of the Institute of Dermatology of Fudan University, Vice President of the Dermatologist Branch of the Chinese Medical Doctor Association, and principal investigator of the phase II. clinical trial of ASC40 medium and severe acne, said:

Excessive sebum secretion is an important factor in causing acne, and inhibiting sebum secretion can reduce the incidence and severity of acne. As a first-in-class drug candidate with a novel mechanism, the fatty acid synthase inhibitor ASC40 has demonstrated promising initial efficacy in phase I clinical trials. We will continue to advance this Phase II clinical study to provide more options for patients with moderate to severe acne."

Dr. Jinzi Wu, Founder, Chairman and Chief Executive Officer of Ascletis, said:

Moderate to severe acne has a lasting impact on patients and remains a huge unmet medical need worldwide. I am pleased to complete patient enrollment in the Phase II clinical trial of the fatty acid synthetase inhibitor ASC40 for the treatment of acne, which is a new milestone for Ascletis in exploring the consumer healthcare market."