First-in-Class, Non-Antibiotic Treatment for Acne Vulgaris Shows Promise in Mid-Stage Trial
Positive data reported at dermatology meeting
Positive phase II results have been reported for a topical nitric oxide-releasing gel (SB204, Novan Therapeutics) for the treatment of acne vulgaris. The new data were presented May 8 at the 2014 Annual Meeting of the Society for Investigative Dermatology, held in Albuquerque, New Mexico.
The phase II, randomized, double-blinded, vehicle-controlled study compared the efficacy, safety, and tolerability of two concentrations of SB204 with that of vehicle gel in subjects with acne vulgaris. SB204 contains NVN1000, a new molecular entity that has both immunomodulatory and antimicrobial activity and that inhibits lipogenesis.
Subjects who met the study’s entry criteria were randomly assigned to receive twice-daily topical applications of SB204 1%, SB204 4%, or vehicle gel for 12 weeks. The trial’s primary endpoint was the absolute change in non-inflammatory lesion counts at the end of treatment. Secondary endpoints included inflammatory lesion counts and the Investigator Global Assessment (IGA). A total of 153 subjects were enrolled, and 129 completed the study.
In the intent-to-treat (ITT) analysis, the mean absolute changes from baseline for non-inflammatory lesions at the end of treatment were –12.1 for SB204 1%, –11.0 for SB204 4%, and –0.30 for vehicle gel (P = 0.05 for SB204 vs. control).
Similarly, the mean absolute changes from baseline in inflammatory lesion counts at the end of treatment were –13.7 for SB204 1%, –15.5 for SB204 4%, and –9.30 for vehicle gel (P = 0.05 for SB204 vs. control). In the ITT population, the median reduction in inflammatory lesions was 62% at week 12.
Statistically significant reductions in both inflammatory and non-inflammatory lesions were observed as early as week 4 (P = 0.05).
There was a noticeable decrease in disease severity after treatment with SB204; no significant differences were observed among treatment groups for the IGA, which required a two-grade change and the achievement of “clear” or “almost clear.”
Both the SB204 1% and 4% doses were safe and generally well tolerated, with no serious adverse events reported. The adverse event and laboratory profiles were similar in SB204- and vehicle gel-treated subjects.
Exploratory measurements of sebum produced on the forehead were also collected in 70 subjects. At week 12, the subjects treated with SB204 had 80% less sebum on the surface of their skin than had those treated with vehicle gel.