Ascletis Pharma has announced 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 randomised, double-blind, placebo-controlled, multicentre 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. Approximately 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.
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.”