Sol-Gel Technologies announced positive topline results from two pivotal phase 3 clinical trials for Twyneo (microencapsulated benzoyl peroxide, 3% and microencapsulated tretinoin, 0.1%) for the treatment of acne vulgaris.
Twyneo is an investigational, fixed-dose combination of tretinoin 0.1%, a retinoid, and benzoyl peroxide 3%, a topical antibacterial. According to the Company, the proprietary microencapsulation technology delivers a stable drug combination of each active ingredient, extending drug delivery time, and reducing potential irritation.
The multicenter, randomized, double-blind, parallel-group, vehicle-controlled trials (SGT-65-04 and SGT-65-05) evaluated the efficacy and safety of Twyneo in 858 patients aged ≥9 years with moderate to severe acne. Patients were randomized 2:1 to receive either Twyneo (n=571) or vehicle cream (n=287) once daily for 12 weeks. The primary end points for both trials included the proportion of patients who achieved ≥2 grade reduction from baseline and “clear” (0) or “almost clear” (1) at Week 12 (based on a 5-point Investigator’s Global Assessment scale), and an absolute change from baseline in inflammatory and non-inflammatory lesion counts at Week 12.
Results from the SGT-65-04 trial showed that 38.5% of patients treated with Twyneo achieved IGA treatment success compared with 11.5% in the vehicle group (P <.001). Additionally, compared with the vehicle group, Twyneo was associated with a statistically significant absolute change from baseline in inflammatory (-14.8 vs -21.6; P <.001) and non-inflammatory lesion counts (-19.8 vs -29.7; P <.001), respectively.
Additionally, findings from the SGT-65-05 trial showed 25.4% of patients treated with Twyneo achieved IGA treatment success vs 14.7% in the vehicle group (P =.017). Twyneo also demonstrated a greater absolute change from baseline in inflammatory (-16.2 vs -14.1; P =.021) and non-inflammatory lesion counts (-24.2 vs -17.4; P <.001) compared with the vehicle group.
Regarding safety, Twyneo was found to be well tolerated with a majority of patients experiencing mild, local skin reactions that improved over time.
“Twyneo combines, for the first time, 2 of the safest and most effective topical agents available for the treatment of acne into a single application,” said Hilary Baldwin, MD, Clinical Associate Professor of Dermatology, Rutgers Robert Wood Johnson School of Medicine, Medical Director, The Acne Treatment and Research Center, Past President the American Acne and Rosacea Society. “Due to stability issues these products don’t play well together and we were never able to recommend even consecutive co-application of the 2 agents; Sol-Gel’s technology has solved that.”
The Company plans to submit a New Drug Application in the second half of 2020.
For more information visit sol-gel.com.