The first new new acne drug in 40 years! FDA accepts clascoterone new drug application

Cassiopea SpA, a pharmaceutical company focused on treating skin diseases, recently announced that the FDA has accepted an application for a new drug for its clascoterone (1% concentration) cream for acne treatment, with a PDUFA date of August 27, 2020It's worth noting that this is the first new treatment for acne in nearly 40 yearsClascoterone (also known as CB-03-01) is a local androgen receptor (AR) inhibitor that is being developed to treat acne (tentativebranded winlevi) and male and female hair loss (tentative brand Name Breezula)According to the FDA reviewing its 1% concentration for acne treatment and later developing its high concentration solution to treat male androgen and male hair loss, it is considered a "first-in-class" drugit is understood that clascoterone (1% concentration) cream targets androgen receptors at the application site to inhibit the local effects of dihydrotestosterone (DHT), which is a key driver of acne lesionsAlthough the exact mechanism of clascoterone's action is unknown, laboratory studies have shown that the chemical competes with androgens, especially DHT, and binds to androgen receptors in sebum glands and hair folliclesClascoterone inhibits the lipid production of cultured oil-producing cells (sebocytes) and reduces pro-inflammatory cytokines affected by androgensAs a result, the pathways that promote the development of acne lesions seem to have been destroyed by clascoteroneBecause the drug may have local effects at the site of its application, the risk of its deviation from the target or systemic side effects is minimizedAnd unlike oral hormone therapy for acne, it may be used in both male and female patientsClascoterone Molecular Structure (from wikipedia)In July 2018, Cassiopea announced the positive top-line results of two key Phase III clinical trials of clascoterone (1% concentration) creamThe two studies enrolled 1,440 acne patients over the age of 9 in the U.Sand Europe with an IGA score of 3 or 4The subjects received Winlevi or a placebo twice a day for 12 weeksAfter completing the test, 604 subjects were enrolled in the open label long-term safety test for a total duration of 12 monthsThe main end points of the study were: the proportion of subjects in each treatment group was at least two percentage points lower than the baseline compared to the baseline, the IGA score in Week 12 was 0 (clear) or 1 (almost clear), and the absolute change in the non-inflammatory lesions count (NILC) and the inflammatory disease count (ILC) baseline for each treatment group in week 12 Statistically, there was a significant improvement in all major clinical endpoints in March, the company released its 2018 Open Label Safety Study, which lasts up to a year and allows no hormonal imbalance in patients' bodies to maximize exposure, even after the surface of drug applications, including the face and torso, has expanded Results confirmed that extended duration and coverage of locally used drugs did not increase significant incidence of side effects Overall, 18.1% of therapeutic adverse events occurred during the study period, with the most common being nasopharyngitis (2.6% of the common cold) and upper respiratory tract infections (1.3%) Diana Porter, chief executive of Cassiopea, said, "Looking forward to working closely with the FDA during the review process, and if approved, clascoterone (1 percent concentration) cream will be the first new new treatment to treat acne in nearly 40 years, providing dermatologists and patients with new and effective treatment alternatives." Cassiopea currently has four clinical candidates in the study, including clascoterone (1% concentration) cream for acne, clascoterone (7.5% concentration) solution for genetic hair loss, will start Phase II clinical study in women in the fourth quarter of this year, start Phase III clinical study in men in the first quarter of 2020; Cassiopea reference sources at the Research Asset Pipeline (from Cassiopea's official website): .