Novan Therapeutics, a specialty pharmaceutical company focused on advancing nitric oxide therapies for a number of diseases, announced today positive Phase 2 study results of its topical SB204 drug candidate for the treatment of acne vulgaris. Acne is a skin disease that affects more than fifty million people in the United States. The Phase 2 study was a double blind, vehicle-controlled, dose-ranging study conducted in 150 subjects with acne. Subjects were randomized evenly to 1% SB204, 4% SB204, or Vehicle Gel and treated for 12 weeks. SB204 demonstrated good cutaneous tolerability with no reported serious adverse events.
Subjects treated with SB204 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% dose of SB204 demonstrated a statistically significant reduction in both noninflammatory (white heads and black heads) and inflammatory lesions (larger red bumps and pustules) compared to Vehicle (p ≤ 0.05, intent-to-treat analysis). 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. Novan's Phase 2 results of SB204 were very impressive, having demonstrated a rapid and clear dose response in subjects with severe acne," commented Dr. Hilary Baldwin, dermatologist at SUNY Downstate Medical Center University Hospital of Brooklyn. "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 SB204 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."
"The results from this Phase 2 study exceeded our expectations," said Nate Stasko, Novan's President. "This data enables us to move forward with late stage clinical development for a fast acting, first-in-class new drug for acne. Our goal is to continue to build value into the platform and execute a financing strategy to rapidly advance SB204 towards commercialization."
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 (n=70). Novan expects to report additional key findings from this study in the second quarter of 2014.