MORRISVILLE, N.C., Oct. 08, 2019 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (Nasdaq:NOVN) today announced that the Company’s Phase 2 molluscum study, designed to evaluate topical nitric oxide product candidate SB206 for the treatment of molluscum contagiosum, has been published in the Journal of the American Academy of Dermatology (“JAAD”). In this Phase 2 study, SB206 demonstrated clinical efficacy with a favorable safety profile.
“The publication of this Phase 2 study through a prestigious platform such as JAAD underscores Novan’s innovative nitric-oxide technology and provides exposure to the results that supported our decision to progress into a Phase 3 molluscum program. There remains an unmet medical need for an efficacious and well-tolerated treatment that can be applied at home by patients or caregivers,” commented Tomoko Maeda-Chubachi, M.D., Ph.D., Novan’s Vice President of Medical Dermatology. Dr. Maeda-Chubachi further commented, “We look forward to reporting out the results from our Phase 3 B-SIMPLE pivotal program in the near future.”
Title: “Efficacy and Tolerability of an Investigational Nitric Oxide-releasing Topical Gel in Patients With Molluscum Contagiosum: A Randomized Clinical Trial”
Authors: Adelaide A. Hebert, Elaine C. Siegfried, Todd Durham, Emily N. de León, Teresa Reams, Elizabeth Messersmith, Tomoko Maeda-Chubachi
Publication: Journal of the American Academy of Dermatology (Available online 03 October 2019), doi: https://doi.org/10.1016/j.jaad.2019.09.064. [Epub ahead of print]
Novan continues to target top line results from the ongoing Phase 3 “B-SIMPLE” (Berdazimer Sodium In Molluscum Patients with Lesions) pivotal trials with SB206 for the treatment of molluscum no later than early in the first quarter of 2020.
About Molluscum Contagiosum
Molluscum contagiosum is a common, contagious skin infection caused by the molluscipoxvirus, affecting approximately six million people in the U.S. annually, with the greatest incidence in children aged one to 14 years. Infected children typically present with 10 to 30 painless, yet unsightly lesions, and, in severe cases, they can have around 100 lesions. Due to the largely pediatric nature of the disease, parents are the caregivers for these children, in most cases, and tend to seek treatment. There are no FDA approved therapies for molluscum, and, upon seeking treatment, caregivers are faced with potentially painful in-office, dermatologist-administered physical procedures or cantharidin, or recommended off-label prescriptions and over-the-counter products. More than half of the patients diagnosed with molluscum are untreated and over 30% of those treated receive an off-label prescription with no molluscum indication or proven clinical efficacy. The average time to resolution is 13 months, however, some children experience lesions that may not resolve in 24 months. Further dissemination of this highly-contagious disease is common, and transmission to other children living in the household is reported to be 41%. There is a significant unmet need in the molluscum treatment landscape.
Novan, Inc. is a clinical development-stage biotechnology company focused on leveraging nitric oxide’s naturally occurring anti-microbial and immunomodulatory mechanisms of action to treat a range of diseases with significant unmet needs. We believe that our ability to deploy nitric oxide in a solid form, on demand and in localized formulations allows us the potential to improve patient outcomes in a variety of dermatology, women’s health and gastrointestinal diseases.
This press release contains forward-looking statements including, but not limited to, statements related to pharmaceutical development of nitric oxide-releasing product candidates and our intention to advance development of certain product candidates, including the timing and progress of our Phase 3 program to evaluate SB206 for the treatment of molluscum. 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, potential for delays and that results of earlier research and preclinical or clinical trials may not be predictive of results, conclusions or interpretations of later research activities or additional trials; risks related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that our product candidates may not be approved or that additional studies may be required for approval or other delays may occur and that we may not obtain funding sufficient to complete the regulatory or development process; our ability to obtain additional funding or enter into strategic relationships or other business development necessary for the further development of our product candidates; and other risks and uncertainties described in our annual report filed with the SEC on Form 10-K for the twelve months ended December 31, 2018, and in our subsequent filings with the SEC. These forward-looking statements speak only as of the date of this press release, and Novan disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.
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