Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today
announced positive proof-of-concept in vitro results and
informative in vivo results with its new chemical entity (NCE),
NVN4100, explored as a potential product candidate for topical
antimicrobial indications in companion animal health.
Novan initiated exploratory work to evaluate NVN4100 and engaged
with animal health experts at Scullion Strategy Group, LLC to
oversee the Company’s initial animal health studies and to assess
technical feasibility and market potential. The in vivo and in
vitro studies were conducted by independent third party animal
health research organizations.
“We are pleased with results that further validate the
anti-bacterial capabilities of our NITRICIL™ platform technology,
specifically with NVN4100, a new chemical entity. The results from
these exploratory studies bolster our confidence in Novan’s
strategy to continue building a data package to support our
strategic partnering efforts for an animal health program. These
exploratory studies were an important step in confirming our
initial premise that there is an opportunity for the NITRICIL™
platform technology in animal health and we believe further
development and evaluations are necessary,” commented Paula Brown
Stafford, President and Chief Executive Officer of Novan.
The exploratory studies were conducted to determine the minimum
inhibitory concentration (MIC) and minimum bactericidal
concentration (MBC) of NVN4100 using broth dilution antimicrobial
susceptibility testing against a set of clinically relevant
microorganisms. Results from the in vitro assay demonstrated that
NVN4100 had both inhibitory and bactericidal effects for a variety
of pathogens. The tested pathogens include both antimicrobial
resistant and antimicrobial susceptible strains of the most
prevalent species associated with skin and ear conditions in animal
health, including Escherichia coli, Pseudomonas aeruginosa,
Staphylococcus pseudintermedius, and Staphylococcus schleiferi.
Additionally, in collaboration with an independent third party
animal health research organization, Novan established a model of
canine pyoderma, one of the most common skin conditions of dogs
that is often resistant to first-line antimicrobials, to evaluate
topically applied NVN4100 in an in vivo setting. The in vivo
results suggest that the canine pyoderma model may serve as an
appropriate tool to facilitate further development of NVN4100 as an
alternative therapy to systemic and topical antimicrobials for
treatment of canine superficial pyoderma or other dermatology
indications.
Dr. Carri Geer, Chief Technology Officer of Novan added, “Among
the results from these studies, one of the most valuable and
informative outcomes of the exploratory work to date is the
establishment and optimization of a clinically relevant model for
canine pyoderma. The antimicrobial activity witnessed in the in
vitro studies provides us with confidence in the potential broad
utility of NVN4100. Those findings coupled with the establishment
of the in vivo model will enable Novan to more efficiently and
rapidly screen product candidates and optimize animal health
targeted formulations as the development program progresses.”
“The results from the in vitro studies showed valuable insight
into the potential of Novan’s innovative platform technology and
the potential of NVN4100 to treat resistant strains and minimize
risk of developing resistance to antibiotics in animals.
Importantly, NVN4100 demonstrated that it was effective, in
cultures, against a wide variety of clinically relevant bacteria
including a number of Staphylococcus pseudintermedius strains,
which is encouraging as the Company looks to advance its animal
health program. We are encouraged by these preliminary results and
look forward to further confirmation of efficacy in clinical
studies, unlocking value of this program,” stated Dr. Thierry
Olivry, DrVet, PhD, DECVD, DACVD, scientific advisor for Novan, and
a board-certified veterinary dermatologist on Faculty for more than
26 years at North Carolina State University College of Veterinary
Medicine.
Based on the results to date and the availability of funding,
Novan intends to conduct additional studies and formulation work
with NVN4100 to build a robust data set and engage with potential
collaborators and strategic partners moving forward. The Company
seeks to publish the full data set from the companion animal health
exploratory studies at an upcoming scientific congress and/or in a
peer-reviewed publication.
About Novan
Novan, Inc. is a clinical development-stage biotechnology
company focused on leveraging its proprietary nitric oxide (NO)
based technology platform, NITRICIL™ to generate macromolecular New
Chemical Entities (NCEs) to treat multiple indications in
dermatology, men’s and women’s health, infectious diseases, and
gastroenterology conditions with significant unmet needs. The
Company’s lead product candidate, SB206, a topical antiviral gel,
for the treatment of molluscum contagiosum, is currently being
evaluated in the B-SIMPLE4 pivotal Phase 3 clinical study. The
Company believes that SB206 as a topical, at-home,
caregiver-applied therapy with a rapid treatment benefit, if
approved, would address an important patient-care need for the
treatment of molluscum.
About NITRICILTM
Novan’s innovative NITRICIL™ technology leverages nitric oxide’s
naturally occurring antimicrobial and immunomodulatory effects to
develop new therapies for unmet medical needs across multiple
therapeutic areas. NITRICIL™ stores the gaseous species on large
polymers, which allow nitric oxide to be applied as timed-release
chemical entities. This technology allows Novan to control the
level of nitric oxide storage, the rate of release, and the
molecule size for targeted delivery. The result is stabilized,
druggable nitric oxide that is optimized for a specific
indication.
Forward-Looking Statements
Any statements contained in this press release that do not
describe historical facts may constitute forward-looking statements
as that term is defined in the Private Securities Litigation Reform
Act of 1995. These statements may be identified by words such as
“believe,” “expect,” “target,” “anticipate,” “may,” “plan,”
“potential,” “will,” “intends” and similar expressions, and are
based on the Company’s current beliefs and expectations. These
forward-looking statements include, but are not limited to,
statements related to the potential therapeutic value of the
Company’s NITRICIL™ platform technology, the Company’s
pharmaceutical development of nitric oxide-releasing product
candidates, the Company’s intention to advance development of
certain product candidates, including the potential for NVN4100 for
antimicrobial indications in companion animal health, and the
Company’s intention to partner with third parties. Forward-looking
statements are subject to a number of risks and uncertainties that
could cause actual results to differ materially from the Company’s
expectations, including, but not limited to, risks and
uncertainties in the Company’s 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 the Company’s product candidates; any
operational or other disruptions as a result of the COVID-19
pandemic; the Company’s ability to enter into arrangements with
third parties to support its development efforts on terms that are
acceptable to the Company or at all; risks and uncertainties in the
clinical development process, including, among others, length,
expense, ability to enroll patients, potential for delays or other
impacts, whether as a result of the COVID-19 pandemic or other
factors, 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; the Company’s ability
to obtain additional funding or enter into strategic or other
business relationships necessary or useful for the further
development of the Company’s product candidates; the Company’s
reliance on arrangements with third parties to support its
operations and development efforts and the risk that such parties
will not successfully carry out their contractual duties or meet
expected deadlines; and other risks and uncertainties described in
the Company’s annual report filed with the Securities and Exchange
Commission on Form 10-K for the twelve months ended December 31,
2020, and in the Company’s subsequent filings with the Securities
and Exchange Commission. Such 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.
INVESTOR AND MEDIA
CONTACT:Jenene Thomas JTC Team,
LLC833-475-8247NOVN@jtcir.com
Novan (NASDAQ:NOVN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Novan (NASDAQ:NOVN)
Historical Stock Chart
From Sep 2023 to Sep 2024