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

Recently, cassiopeaspa, a pharmaceutical company focused on skin diseases, announced that the FDA of the United States has accepted its application for a new drug for the treatment of acne with clascoterone (1% concentration) cream The date of PDUFA is August 27, 2020 It is worth mentioning that this is the first new mechanism drug for acne treatment in recent 40 years Clascoterone (also known as cb-03-01) is a local androgen receptor (AR) inhibitor, and the new chemical entity is developing treatments for acne (tentatively named winlevi) and male and female hair loss (tentatively named breezula) It is considered as a "first in class" drug according to the results of FDA's review of its 1% concentration for acne treatment and later development of its high concentration solution for male androgen alopecia It is understood that claricoterone (1% concentration) cream targets the androgen receptor at the application site and inhibits the local effect of dihydrotestosterone (DHT), which is the key driving factor for the development of acne lesions Although the exact mechanism of clascoterone's action is still unknown, laboratory studies have shown that the chemical competes with androgens, especially DHT, and binds to androgen receptors in sebaceous glands and hair follicles Clascoterone can inhibit the lipid production of Sebocytes and reduce the proinflammatory cytokines affected by androgen Therefore, the way to promote the development of acne seems to be destroyed by clascoterone Since the drug may have local effects at the application site, the risk of deviating from the target or systemic side effects is minimized And unlike oral hormone therapy for acne, it may be used in men and women Clascoterone 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) cream The two studies enrolled 1440 acne patients over 9 years of age in the United States and Europe with an IgA score of 3 or 4 Subjects received winlevi or placebo twice a day for 12 weeks After completion of the trial, 604 subjects were enrolled in the open label long-term safety trial for a total duration of 12 months The primary end points of the study were: the proportion of subjects in each treatment group decreased by at least two percentage points compared with the baseline, the IgA score was 0 (clear) or 1 (almost clear) at week 12, and the absolute change of noninflammatory lesion count (nilc) and inflammatory lesion count (ILC) at week 12 in each treatment group Statistically, all major clinical endpoints improved significantly In March this year, the company also released the results of 2018 open label safety research, with a treatment period of up to one year Even after the expansion of the drug application surface including the face and trunk, there was no hormone imbalance in the patient's body, thus maximizing the exposure area of the patient The results showed that prolonged duration and coverage of topical drugs did not increase the incidence of significant side effects Overall, 18.1% of the patients had therapeutic adverse events during the study period, the most common of which were nasopharyngitis (2.6% of the common cold) and upper respiratory tract infection (1.3%) Diana Porter, chief executive of Cassiopea, said, "we look forward to working closely with FDA in the review process If approved, clascoterone (1% concentration) cream will become the first new mechanism drug for acne treatment in nearly 40 years, providing new and effective alternative treatment for dermatologists and patients." Cassiopea currently has four clinical candidates under development, including clascoterone (1% concentration) cream for acne; clascoterone (7.5% concentration) solution for genetic alopecia, which will launch phase II clinical research in women in the fourth quarter of this year and phase III clinical research in men in the first quarter of 2020; antibiotic cb-06-01 for acne; and immunomodulator cb-06-02 Genital warts Cassiopea's asset pipeline under research (from Cassiopea's official website) reference source: [1] Cassiopea announcements of daacceptance of its new drag application for clascorterone cream 1%, the first new mechanism of action for acnein nearly40 years [2] company's official website, etc Penicillin is the reprinted content of yaozhi.com, and the copyright belongs to the original author The purpose of reprinting is to transmit more information, which does not represent the view of this platform If the content of the work, copyright and other issues are involved, please contact our website message, we will delete the content in the first time.