DURHAM, N.C.—Novan Therapeutics, a specialty pharmaceutical company focused on advancing nitric oxide therapies for a number of diseases, presented data from its Phase 2 clinical trial for its topical product candidate, SB204 in subjects with acne vulgaris on May 8 at the 2014 Annual Meeting of the Society for Investigative Dermatology (SID). The poster titled “Phase 2 study of efficacy and safety of SB204 in the treatment of acne vulgaris” was presented by M. Joyce Rico, M.D., chief medical officer for Novan.
“The results from this Phase 2 study exceeded our expectations,” says 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 expects the company to move forward with another clinical trial focused on safety and additional efficacy testing in six to nine months. He notes that SB204 has been well-tolerated to date—a key consideration for a drug that may be used daily for years. “Acne patients are getting younger and younger,” he notes, “with some as young as 9 or 10 years old. In such cases, they may be on medication for a decade or longer.” Surveys show that compliance is a key concern of dermatologists, Stasko adds.
James J. Leyden, M.D., Penn Medicine, Perelman Center for Advanced Medicine said, “The recent attention from the CDC and global government agencies on the use of antibiotics and microbial resistance highlights the increasing need to curtail the overuse of antibiotics in dermatology.” Dr. Leyden concluded, “SB204 provides a topical, non-antibiotic solution with demonstrated clinical activity against P. acnes.”
The emergence of P. acnes resistance in acne is well documented and parallels the rise of superbugs that are able to evade the most effective antibiotics. As recently as last week, the World Health Organization (WHO) cautioned that the implications of the global threat of antibiotic resistance “will be devastating.”
In a 2013 review in Ecotoxicology and Environmental Safety the problem pointed out by WHO was underscored. Large amounts of antibiotics are released into municipal wastewater due to incomplete metabolism in humans or due to disposal of unused antibiotics, the report observed*, which finally find their ways into different natural environmental compartments. “The emergence and rapid spread of antibiotic resistant bacteria (ARB) has led to an increasing concern about the potential environmental and public health risks. ARB and antibiotic resistant genes (ARGs) have been detected extensively in wastewater samples. Available data show significantly higher proportion of antibiotic resistant bacteria contained in raw and treated wastewater relative to surface water. According to these studies, the conditions in wastewater treatment plants are favorable for the proliferation of ARB,” the authors noted
“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.”
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.
* “Detection and fate of antibiotic resistant bacteria in waste water treatment plants:” A review by Chryssa Bouki, Danae Venieri, Evan Diamadopoulos