Novan’s NITRICIL™ Technology Shows In Vitro Antiviral Effect Against SARS-CoV-2 in Human Airway Infection Model
October 14 2020 - 7:00AM
Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today
announced positive in vitro results showing the potential efficacy
of its NITRICIL™ platform technology as an antiviral against
SARS-CoV-2, the virus that causes COVID-19. To evaluate the ability
of its NITRICIL™ platform technology as a potential nasal treatment
option for COVID-19, the Company initiated in vitro assessments
targeting the reduction of viral burden in differentiated normal
human bronchial epithelial cells. The studies were conducted at the
Institute for Antiviral Research at Utah State University and these
results demonstrate the first instance of an antiviral effect from
a nitric oxide-based medicine in a 3-D tissue model that has
similar structure to the human airway epithelium.
The results from the in vitro assessment of
concentrations as low as 0.75 mg/mL demonstrated that berdazimer
sodium reduced 90% of virus after repeat dosing, once daily.
“COVID-19 continues to have a major ongoing
impact on global health and there remains a direct need for a safe
and effective antiviral therapy. The naturally occurring antiviral
effects of nitric oxide and the results we have generated from this
assessment, provide us with confidence that our NITRICIL™ platform
technology may be an effective treatment for COVID-19. We also
believe the data from this sophisticated model of the human
respiratory tract demonstrate a high potential for clinical
translation,” commented Paula Brown Stafford, Chairman and Chief
Executive Officer of Novan. Novan plans to initiate Chemistry,
Manufacturing, and Controls (CMC) work with a global leader in
providing integrated services, superior delivery technologies and
manufacturing solutions to develop an intranasal formulation of
berdazimer sodium for use in the Company’s COVID-19 program.
Dr. Carri Geer, Senior Vice President and Chief
Technology Officer added, “With these encouraging in vitro results
in hand, the next step is to advance our program into preclinical
IND-enabling studies to further confirm the safety of our NITRICIL™
technology when administered intranasally. We are in the process of
finalizing arrangements with a global leader in drug development to
assist in our development activities as we work toward a potential
IND filing targeted in 2021.”
Based on the scientific literature and data
available to-date with berdazimer sodium and Novan’s product
candidate SB206, Novan believes that nitric oxide may inhibit viral
replication by disrupting protein function critical for viral
replication and infection through generation of reactive
intermediates.
About NovanNovan, 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.
Forward-Looking StatementsThis
press release contains forward-looking statements including, but
not limited to, statements related to the potential therapeutic
value of our NITRICIL™ platform technology, our pharmaceutical
development of nitric oxide-releasing product candidates, our
intention to advance development of certain product candidates, and
our 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 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; our ability to enter
arrangements with third parties to support our development efforts
on terms that are acceptable to us or at all; risks and
uncertainties in the clinical development process, including, among
others, length, expense, ability to enroll patients, reliance on
third parties, 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, 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 or other business relationships necessary or useful for
the further development of our product candidates; the risk that
disruptions at the FDA or other agencies could cause such agencies
to cancel or postpone meetings or otherwise impact the ability of
such agencies to provide regulatory guidance or feedback or timely
review and process our regulatory submissions, all of which could
have a material adverse effect on our business; risks related to
the manufacture of clinical trial materials; any operational or
other disruptions as a result of the COVID-19 pandemic, including
any delays or disruptions to the enrollment in and conduct of the
B-SIMPLE4 Phase 3 trial; 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, 2019, as amended, 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.
INVESTOR AND MEDIA
CONTACT:
Jenene Thomas JTC Team,
LLC833-475-8247NOVN@jtcir.com
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