Once Daily Acne Therapy Shown to Reduce Lesions, Inflammation
ASC40 blocks facial sebum production by inhibiting de novo lipogenesis in sebocytes and inflammation by decreasing cytokine secretion and Th17 differentiation.
Positive results have been announced from a phase 3 clinical trial evaluating the efficacy and safety of ASC40 (denifanstat) for the treatment of moderate to severe acne vulgaris in adult patients, Ascletis Pharma announced in a release.1 The therapy has the potential to be a first-in-class oral therapeutic for acne.
Once Daily Acne Therapy Shown to Reduce Lesions, Inflammation / Ocskay Bence - stock.adobe.com
Results from the trial (NCT06192264) showed that ASC40 met all primary study endpoints, including percentage of treatment success based on the investigator's global assessment (IGA) in each patient group. The therapy also met all key secondary endpoints, including percentage change in non-inflammatory lesion counts compared to baseline.
"The Phase 3 clinical trial results for denifanstat are highly encouraging,” Leihong Xiang, principal investigator on the trial, said in a release.1 Denifanstat's first-in-class mechanism targeting FASN directly addresses a key cause for acne, establishing it as a groundbreaking therapeutic approach in acne treatment.”
ASC40 blocks facial sebum production by inhibiting de novo lipogenesis in sebocytes and inflammation by decreasing cytokine secretion and Th17 differentiation. Because most other current acne treatments do not treat the underlying cause of the condition—overproduction of sebum—ASC40’s mechanism of action makes it unique among other therapies.
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The clinical trial was a multicenter, randomized, double-blind, placebo-controlled phase 3 study evaluating the efficacy and safety of ASC40 for the treatment of moderate to severe acne vulgaris in adult patient aged between 18 and 40 years. The study cohort included 480 patients with an initial IGA of moderate or severe.
During the trial, patients randomly received either 50 mg ASC40 or placebo once daily after dinner for 12 weeks. The study included a total of 6 screenings and follow up visits, as well as blood tests, blood biochemistry, lipid profile, pregnancy test and routine urine tests. Patients were excluded from the trial if they had cystic acne, secondary acne, other significant skin conditions or thicker facial hair.
The study found that 33.2% of patients who received the therapy had treatment success, compared to 14.6% of patients who received placebo. For total lesion count, 57.4% of patients in the treatment group had percent reduction, compared to 35.4% in the placebo group. Additionally, percent reduction from baseline in inflammatory lesion count was 63.5% for patients receiving ASC40, compared to 43.2% for placebo.
ASC40 was seen to be safe and tolerable, with a similar rate of adverse events as placebo. All adverse events occurring in the study were mild to moderate in severity, with dry skin and dry eye being the most common.
"We are extremely pleased with the topline results of our Phase 3 trial,” Jinzi Jason Wu, PhD, founder, chairman and CEO of Ascletis, said in a release.1 “Denifanstat tablets demonstrated impressive efficacy beyond treatment success, showing significant reductions in total lesion count, inflammatory lesion count, and non-inflammatory lesion count.”
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