Therapeutics, a specialty pharmaceutical company focused on
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 ith 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
"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
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.
About Novan, Inc.
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.
To learn more about Novan Therapeutics, please visit www.novantherapeutics.com.
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