Novan announces positive Phase 2 results for novel acne treatment

Nitric oxide-based therapy shows statistically significant results in only four weeks

Lloyd Dunlap
DURHAM, N.C.--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 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 percent SB204, 4 percent 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 in a third of the time compared to the 12-week treatment duration generally needed to see efficacy with a monotherapy. At four weeks, the 4 percent 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.”
 
In dermatology, says Whitney P. Bowe, M.D., clinical assistant professor of dermatology at the State University of New York Downstate Medical Center,.studies show that resistant Propionibacterium acne (P. acnes) makes patients more likely to fail treatment, although research has not yet established how much more likely.

Dermatologists also may not fully appreciate their specialty’s contribution to overall antibiotic use, says Guy F. Webster, M.D., Ph.D. Although dermatologists represent about one percent of the U.S. physician population, based on unpublished pharmaceutical industry monitoring data the specialty writes almost five percent of antibiotic prescriptions.
 
“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.”
 
Stasko points out that Novan’s platform—which couples nitric oxide to a macromolecular scaffold—is stable and scalable with attractive pharmacokinetics, not releasing the active ingredient too slowly nor too fast. Other small molecule therapeutics have failed to show these desirable properties. Stasko also notes that the macromolecule is considered a component of the drug product, not merely an excipient.
 
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. Although clearly not prepared to release findings, Stasko did say that he was “very enthusiastic about the package.”
 
Novan Therapeutics is a privately-held, clinical-stage specialty pharmaceutical company bringing the power of nitric oxide therapeutics to dermatology and wound care. Novan’s core technologies solve the previous delivery issues with nitric oxide by storing the gaseous species on macromolecules that result in a diverse pipeline of “timed-release” nitric oxide-releasing new chemical entities. Novan is currently developing a range of drug products including topical gels, creams, ointments, and wound dressings which can be tailored to treat specific skin conditions.

Lloyd Dunlap

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