Novan Therapeutics, a specialty pharmaceutical company focused on medical nitric oxide therapies has announced positive Phase 2 study results of its topical drug candidate for the treatment of acne vulgaris. The double blind, vehicle-controlled, dose- ranging study included 150 subjects with acne. Subject were randomized evenly to 1 percent, 4 percent, or vehicle gel and treated for 12 weeks. The topical drug demonstrated good cutaneous tolerability with no reported serious adverse side effects.
Subjects treated with the drug recognized a benefit three times faster than the 12-week treatment duration generally needed to see efficacy with a monotherapy. At four weeks, the 4 percent dose demonstrated a statistically significant reduction in both non-inflammatory (white heads and black heads) and inflammatory lesions (larger red bumps and pustules) compared to vehicle gel. Statistically significant reductions were also observed in both the primary and secondary endpoints for lesion types at the 12-week time point.
“There currently remains a need for new agents to treat the growing number of patients suffering from acne vulgaris,” says Hilary Baldwin, M.D., dermatologist at SUNY Downstate Medical Center University Hospital of Brooklyn (NY). “Novan’s Phase 2 results were very impressive, having demonstrated a rapid and clear dose response in subjects with severe acne. In fact, I would typically prescribe an oral antibiotic to the type of patients that were recruited in this study. While systemic antibiotics are an effective treatment option, they may lead to the development of antibiotic resistance. Importantly, with advanced clinical testing, I believe this treatment has the potential to be used as a first-line monotherapy, or in combination with existing drugs, providing an exciting new solution for patients with acne.”
Exploratory measurements of sebum and the quantitative analysis of the chemical composition of the oils produced by the skin were also collected in a subset of subjects. The company expects to report additional key findings from this study later this year.