DURHAM, N.C.--(BUSINESS WIRE)--Novan Therapeutics, a clinical-stage biotechnology company focused on advancing innovation in dermatology via nitric oxide therapies, today announced that the Company has achieved target enrollment in its Phase 2b clinical study with SB204 for the treatment of acne vulgaris. Acne is the most common skin disease in the United States, affecting more than 50 million people. “The timely achievement of our enrollment target is testimony to the interest from the dermatology community in our SB204 program. We believe SB204 has a differentiated profile from other therapies. The trial will help us evaluate it as a potential new solution for dermatologists and patients to reduce P. acnes colonization without the development of antibiotic resistance,” said Dr. M. Joyce Rico, Novan’s Chief Medical Officer.
The Phase 2b study is a randomized, evaluator-blinded, vehicle-controlled study evaluating 200 subjects with moderate to severe acne vulgaris across 20 sites throughout the United States. The primary objective of the study is to compare efficacy, tolerability, and safety of SB204 Gel versus Vehicle Gel applied topically once or twice daily for up to 12 weeks. Primary outcome measures include the change in number of inflammatory and non-inflammatory lesions, as well as success on an Investigator Global Assessment.
Following the successful enrollment of the Phase 2b acne study, Novan plans to launch the clinical development of SB206, a topical anti-viral that could lead to a treatment for human papillomavirus (HPV) infections. SB206 is expected to enter a Phase 2 clinical trial in the second quarter of 2015 for the treatment of external genital warts. About two-thirds of healthy American adults are infected with HPV, and genital warts remain the world’s most common sexually transmitted disease.
Dr. Nathan Stasko, President of Novan, stated, “Our expanding number of clinical programs is intended to leverage the antimicrobial breadth of the Nitricil™ platform. For our program in HPV, we target translating preclinical antiviral efficacy against papilloma virus into success in the clinic, much as we have done with the antibacterial efficacy against P. acnes and the ongoing success of SB204."
Novan’s nitric oxide platform also has demonstrated preclinical efficacy against:
- T. rubrum – Microorganisms causing fungal foot infections, including onychomycosis (toenail fungus)
- S. aureus – Pathogens associated with atopic dermatitis flares
- P. aeruginosa – Bacteria leading to drug-resistant chronic wound infections
“Our team will continue to execute on the plan to advance SB204 toward commercialization while we aim to selectively expand our pipeline of transformative therapies in dermatology,” concluded Dr. Stasko.
About Novan, Inc.
Novan is a privately-held, clinical stage biotechnology company advancing potentially best-in-class therapies using drugable nitric oxide. Nitric oxide, one of the most studied molecules in human physiology, has been shown to exhibit broad anti-microbial activity and to promote vasodilation, regulate inflammation, stimulate tissue repair, and eradicate cancer cells. Novan’s initial focus is on emotionally and/or physically debilitating skin diseases. The company's patented Nitricil™ technology overcomes the previous delivery issues with nitric oxide by stably storing the gaseous species as a solid that can be transformed into targeted therapeutics. The design of our products is driven by the patient experience, as we aim to create medicines that are safe, easily accessible, and can improve outcomes by using nitric oxide to target multiple aspects of disease pathology.
This press release contains forward-looking statements involving risks and uncertainties, both known and unknown, that may cause actual results to differ materially from those indicated. Actual results may differ materially due to a number of factors, including, but not limited to, risks associated with pharmaceutical development, clinical trials that may not proceed as intended or produce the results expected, clinical trials that cost more, are less effective and take longer to complete than expected, raw materials and drug supply, changes in regulatory requirements, competition, and financing.
To learn more about Novan, please visit www.novantherapeutics.com.