Sol-Gel announces positive results for combination therapy for acne
Sol-Gel Technologies Ltd. has announced positive results from its phase 2 clinical trial of its topical drug candidate TWIN for treating acne vulgaris.
TWIN is a once-daily cream containing a fixed-dose combination of tretinoin and benzoyl peroxide, separately encapsulated in a silica-based proprietary drug delivery technology, according to a news release.
There were 726 patients aged 9 years and older with facial acne vulgaris enrolled at 36 sites in the U.S. for the six-arm, double-blind, placebo-controlled trial that evaluated efficacy, tolerability and safety of two concentrations of TWIN, which contained a higher or lower concentration of tretinoin and an identical concentration of benzoyl peroxide, to vehicle.
Inclusion criteria included 20 to 50 inflammatory lesions, 25 to 100 non-inflammatory lesions and an investigator’s global assessment score of 3 or 4 (“moderate” or “severe”) on a five-point scale that ranges from a score of zero, representing “clear” skin, to a score of four, representing “severe” disease. Patients were randomized into six separate treatment cohorts and instructed to apply the investigational drug once daily before bedtime for 12 weeks, according to the release.
The study also evaluated the separate active components of TWIN; both the higher and lower concentrations of encapsulated tretinoin and encapsulated benzoyl peroxide administered as a single agent.
There were statistically significant improvements in all pre-defined co-primary and secondary efficacy endpoints for TWIN, as compared to vehicle. TWIN also exhibited favorable efficacy results compared to its active components, according to the release.
There were no treatment-related serious adverse events with TWIN. Four patients treated with TWIN High and two patients treated with TWIN Low discontinued due to related adverse events, which were primarily mild or moderate in severity, according to the release.
“Acne is a multifactorial disorder and is better treated with drugs affecting as many components as possible that contribute to its development,” Guy Webster, MD, PhD, clinical professor of dermatology at Jefferson Medical College, Thomas Jefferson University, Philadelphia, and the medical monitor of the phase 2 study, stated in the release. “TWIN is pursuing this approach by designing a fixed-dose combination of tretinoin, which is a modulator of cellular differentiation, keratinization and inflammatory processes, and benzoyl peroxide, which is an oxidizing agent with bactericidal and keratolytic effects.”
Based on the study results and subject to an end of phase 2 meeting to be scheduled with the FDA, Sol-Gel plans to initiate a phase 3 program to measure the efficacy, tolerability and safety of TWIN for treating acne in adults and adolescents.
Sol-Gel also plans to use results from the encapsulated tretinoin arms of the study to develop its single agent, encapsulated tretinoin drug product candidate, SIRS-T, as a first-line treatment for adult and adolescent patients with acne, according to the release.