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Novan Announces First Patient Dosed in Phase 2 Molluscum Contagiosum Trial with SB206
"Broadening Novan's clinical development pipeline to include the viral area within dermatology has been a significant focus of the team," stated
The Phase 2 multi-center, randomized, double-blind, vehicle-controlled, ascending dose clinical trial is designed to evaluate the efficacy, safety and tolerability of SB206 in 192, with an option to increase to 256, children and adolescents, 2 to 17 years of age, with molluscum. Patients will be treated with one of three concentrations of SB206 or vehicle for up to 12 weeks. The primary endpoint is the proportion of patients achieving complete clearance of all molluscum lesions at Week 12. Top line results are targeted for the fourth quarter of 2018.
Molluscum contagiosum is a common skin disorder caused by the molluscipoxvirus and affects mainly healthy children1. Molluscum affects approximately six million people2 in the U.S. annually and has the greatest incidence in individuals aged 1 to 14 years3, with a 5% to 11% prevalence in children4. There is no
1Dohil M,; Lin P, Lee J, Lucky AW, Paller AS, Eichenfield LF. The epidemiology of molluscum contagiosum in children. J Am Acad Dermatol 2006; 54: 47-54.
2QuintilesIMS. Market Opportunity Assessment EGW, Common Warts and Molluscum,
3Schofield JK, Fleming D, Grindlay D, Williams H. Skin conditions are the commonest new reason people present to general practitioners in
4Olsen JR, Gallacher J, Finlay AY, Piguet V,
This press release contains forward-looking statements including, but not limited to, statements related to pharmaceutical development of nitric oxide-releasing product candidates and the future prospects of our business and our product candidates. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from our expectations, including, but not limited to, risks and uncertainties in the clinical development process, including, among others, length, expense, ability to enroll patients, reliance on third parties, and that results of earlier research and preclinical or clinical trials may not be predictive of results, conclusions or interpretations of later research or trials; the lengthy and unpredictable nature of the U.S. Food and Drug Administration's drug approval process, and other risks and uncertainties described in our annual report filed with the
Director, Corporate Communications and Administration