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Sol-Gel Technologies Announces 50% Enrollment in Pivotal Phase III TWIN Program for the Treatment of Acne Vulgaris
Patient enrollment of the pivotal Phase III TWIN clinical trials is on scheduleTop-line results expected in the fourth quarter of 2019NESS ZIONA, Israel,
About this update from Sol-gel Technologies Ltd.
[{"type":"text","content":"Patient enrollment of the pivotal Phase III TWIN clinical trials is on scheduleTop-line results expected in the fourth quarter of 2019NESS ZIONA, Israel, April 15, 2019 (GLOBE NEWSWIRE) -- Sol-Gel Technologies Ltd. (NASDAQ:SLGL) (\"Sol-Gel\" or the \"Company\"), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, announced today that it has completed enrollment of half of the patients in its pivotal Phase III clinical trials of TWIN in subjects with acne vulgaris. TWIN is a once daily topical cream containing a fixed-dose combination of encapsulated benzoyl peroxide and encapsulated tretinoin using Sol-Gel's proprietary microencapsulation platform.\"We have reached another important milestone for the company as patient enrollment for the TWIN Phase III program has progressed well, reinforcing the need for a new treatment option for acne vulgaris containing a safe and efficacious combination of encapsulated benzoyl peroxide and encapsulated tretinoin,\" commented Dr. Alon Seri-Levy, Chief Executive Officer of Sol-Gel. \"Based on the current rate of enrollment, we plan to report top-line results in the fourth quarter of 2019.\"The program consists of two randomized, double-blind, vehicle-controlled Phase III clinical trials. Each pivotal trial is planned to enroll approximately 420 subjects aged 9 and above at a 2:1 ratio, with a power of 99%. The objective of the study is to evaluate the efficacy and safety of TWIN, a topical cream containing encapsulated benzoyl peroxide and encapsulated tretinoin, compared to a vehicle when applied once daily for 12 weeks in patients with moderate-to-severe acne vulgaris.The pivotal TWIN clinical program is being executed under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). The SPA reflects FDA's agreement that the protocol design, primary endpoints and statistical analysis approach for Sol-Gel's Phase III program evaluating TWIN for the treatment of patients with acne vulgaris are acceptable to support a future New Drug Application (NDA) filing for marketing approval.About TWINTWIN is a novel non-antibiotic topical cream for the treatment of acne vulgaris that is designed to be tolerable and highly effective. TWIN is the first ac...