Novan Further Expands its Proprietary Nitric Oxide Platform
October 18 2019 - 8:30AM
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 IkkalaDirector,
Investor Relations, Communications & Business
Developmentcikkala@novan.com
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