Novan, Inc. (“the Company” or “Novan”) (Nasdaq:NOVN) today announced that the Company has submitted a request for a pre-IND meeting with the U.S. Food and Drug Administration (FDA) for new product candidate, SB207
MORRISVILLE, N.C., Oct. 18, 2019 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq:NOVN) today announced that the Company has submitted a request for a pre-IND meeting with the U.S. Food and Drug Administration (FDA) for new product candidate, SB207. The Company anticipates that the meeting will be held in December 2019.
Novan has identified targeted viral opportunities of high unmet need where the Company’s nitric oxide releasing technology could provide clinical benefit to patients. The SB207 product incorporates the Company’s existing drug substance, berdazimer sodium, with a new formulation specifically engineered and tailored to be effective within a number of viral indications.
“Our pre-clinical and clinical anti-viral insights captured to-date demonstrate an inherent and definable clinical benefit with berdazimer sodium. The extrapolation of this data provides the basis for further exploration of a number of viral indications,” commented Carri Geer, Ph.D., Senior Vice President and Chief Technology Officer of Novan. Dr. Geer further commented, “In creating SB207, we aimed to leverage the totality of our anti-viral learnings to develop a specific formulation and nitric oxide release profile optimized for a variety of viral-based indications.”
Novan also anticipates that SB207 is a product candidate well-suited for an external genital warts program. The drug substance in SB207 has previously been tested in Phase 2 clinical studies of Novan’s existing product candidate (SB206) for external genital warts and molluscum contagiosum. Data from these trials demonstrated that SB206 was both efficacious and well-tolerated.
About Novan
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.
Forward-Looking Statements
This press release contains forward-looking statements including, but not limited to, statements related to pharmaceutical development of nitric oxide-releasing product candidates, our intention to advance development of nitric oxide-releasing product candidates, which is subject to our ability to obtain additional funding or enter into strategic relationships to enable such development, 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 our ongoing or future product development activities and preclinical studies, which may not prove successful in demonstrating proof-of concept, or may show adverse toxicological findings, and even if successful may not necessarily predict that subsequent clinical trials will show the requisite safety and efficacy of our product candidates; the clinical development process, including, among others, the timing of filing of clinical trial applications and INDs, any approvals thereof and the timing of commencement, length, expense, ability to enroll patients, reliance on third parties, and potential for delays of such clinical trials; 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.
CONTACT:
(Investors & Media)
Cole Ikkala
Director, Investor Relations, Communications & Business Development
cikkala@novan.com
