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 schedule
Top-line results expected in the fourth quarter of 2019
“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
TWIN 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 acne treatment that contains a fixed-dose combination of encapsulated benzoyl peroxide and encapsulated tretinoin, which are separately encapsulated in silica using our proprietary technology. Tretinoin and benzoyl peroxide are widely believed to be effective as a combination treatment for acne. The silica microcapsule protects tretinoin from oxidative decomposition by benzoyl peroxide, thereby enhancing the stability and shelf-life of the product. The silica shell also creates a barrier between the drug substances and the skin and, as a result, is expected to reduce irritation typically associated with topical application of benzoyl peroxide and tretinoin, thereby increasing the tolerability of TWIN on acne-affected skin.
About Acne Vulgaris
Acne vulgaris is a common multifactorial skin disease that according to the American Academy of Dermatology affects approximately 40 to 50 million people in the
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Source: Sol-Gel Technologies Ltd.