Sol-Gel says primary, secondary endpoints achieved in Phase 3 trials of Epsolay
Sol-Gel Technologies announced positive results from its Phase 3 program evaluating Epsolay microencapsulated benzoyl peroxide cream, 5%, made with the Company's proprietary microencapsulation technology, for the treatment of papulopustular rosacea. In two 12-week clinical studies, SGT 54-01 and SGT 54-02, Epsolay demonstrated statistically significant improvement in both co-primary endpoints of the number of patients achieving "clear" or "almost clear" in the Investigator Global Assessment and absolute mean reduction from baseline in inflammatory lesion count. In an additional analysis, Epsolay demonstrated rapid efficacy achieving statistically significant improvements on both co-primary endpoints compared with vehicle as early as Week 2. Epsolay demonstrated a favorable safety and tolerability profile similar to vehicle. Epsolay is the first in a pipeline of dermatologic product candidates in development using Sol-Gel's proprietary microencapsulation technology. This platform was designed to enable drug substances to be entrapped in porous silica microcapsules in order to address the limitations of topical drug delivery by stabilizing active drug ingredients, extending drug delivery time and reducing potential irritation caused by direct application to the skin. In the fourth quarter of 2019, top-line Phase 3 results are expected for TWIN, the Company's investigational fixed-dose combination of microencapsulated benzoyl peroxide and microencapsulated tretinoin being studied for acne vulgaris.