Date: 2015-11-12
Type of information: Recruitment of the first patient
phase: 3
Announcement: recruitment of the first patient
Company: Cassiopea (Switzerland)
Product: Winlevi™ (ortexolone 17?-Propionate (CB-03-01) 1% Cream)
Action
mechanism: corticosteroid. Winlevi™ (cortexolone-17α-propionate) is a steroid belonging to the family of cortexolone derivatives. This topically delivered small molecule penetrates the skin to reach the androgen receptors of the sebaceous gland. Winlevi™ has completed Phase II clinical trials and Phase III trials are scheduled to commence in H2 2015. Winlevi™ displaces the androgen hormones from the androgen receptors on the sebaceous gland within the hair follicle. Because the follicle is not obstructed, it does not provide P. acnes with the optimal conditions that it needs to colonize the follicle and cause subsequent inflammation.
Disease: facial acne vulgaris
Therapeutic area: Dermatological diseases
Country: USA
Trial details:
Latest
news: * On November 12, 2015, Cassiopea announced that it has commenced the enrolment of patients into the phase III pivotal trials for Winlevi, a novel topical anti-androgen, for acne. The first patients were enrolled in the US on November 9. The Winlevi™ phase III clinical trial program consists of two pivotal trials in approximately 70 sites in both the US and various countries in Europe. Approximately 1,400 male and female subjects 9 years or older with moderate to severe acne (grades 3-4 on IGA) are targeted for enrolment. The primary endpoints are the proportion of subjects achieving success at week 12 with success meaning an IGA score of “clear” (score =0) or “almost clear” and at least a two-point reduction in IGA and an absolute change from baseline in both inflammatory and non-inflammatory lesion counts in each treatment group at week 12. The Company expects data to be available in the second half of 2017. * On August 4, 2015, Cassiopea, a clinical stage specialty pharmaceutical company focused on developing and commercializing innovative and differentiated medical dermatology products addressed to the topical treatment of acne, androgenic alopecia (AGA) and genital warts announced that the FDA has agreed to its clinical protocol in a special protocol assessment. The protocol is titled, “A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle Controlled Study to Evaluate the Safety and Efficacy of Cortexolone 17α-Propionate (CB-03-01) 1% Cream Applied Twice Daily for 12 Weeks in Subjects with Facial Acne Vulgaris”.The agreed primary endpoints to be assessed for each treatment group at Week 12 are: 1) Investigator’s Global Assessment (IGA) success defined as scoring 0 or 1 (clear or almost clear) AND at least 2-grade improvement from baseline. Enrollment of the first patient is expected in the second half of 2015, and last patient out is expected in the first half of 2017. Winlevi™ has completed four Phase I studies in a total of 92 subjects, being healthy volunteers and acne patients, and three Phase II studies in 477 subjects with acne. Results of Phase II clinical trials were received in June 2014. The end of Phase II meeting has been achieved in January 2015.
2) Absolute change from baseline in non-inflammatory lesion counts (NILC).
3) Absolute change from baseline in inflammatory lesion counts (ILC).
