China NMPA approves Phase II trial of Ascletis acne therapy drug ASC40

Chinese biotechnology company Ascletis Pharma Inc. has announced that China NMPA (National Medical Products Administration) recently approved the Phase II clinical trial of ASC40 for patients suffering from acne vulgaris.

According to reliable sources, 180 patients will participate in the phase II trial which will be double-blind, and placebo-controlled. They will be assigned to one of the four groups randomly (25 mg, 50 mg, 75mg, placebo).

The trial will allow researchers to assess the efficacy and safety of ASC40 for the treatment of patients suffering from moderate to severe acne.

For the record, acne vulgaris is a medical condition that affects 640 million people worldwide and is the eighth most common disease in the world. The onset of the condition often happens during puberty. Approximately 85% of young adults and adolescents aged between 12-25 years suffer from acne currently.

FASN (fatty acid synthase) is a crucial enzyme that is known to regulate de novo lipogenesis. Production of human sebum primarily requires de novo lipogenesis, which shoots up due to acne and is suppressed by ASC40, a FASN inhibitor.

Dr. Jinzi.J.Wu, Chairman, Founder, and CEO of Ascletis Pharma was quoted saying that the Phase II study will be the second clinical trial using ASC40 approved by China NMPA this month.

He further added that this study has shown that lipid metabolism plays a vital role in various disease areas and is the third indicator for ASC40 following recurrent glioblastoma (GBM), and non-alcoholic steatohepatitis (NASH).

Notably, the global acne medication market was assessed at USD 11.86 billion in 2019 and is estimated to be worth USD 13.35 billion by 2027. First-line treatments for acne vulgaris currently include topical retinoids, oral isotretinoin, antibiotics, and androgen receptor inhibitor.

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