Novan Announces Favorable Preclinical Safety Data and Intent to Advance SB019 for Treatment of COVID-19
09 Novembro 2021 - 10:35AM
Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today
announced promising preclinical safety results with berdazimer
sodium in a 14-day GLP repeat dose intranasal toxicity study. These
findings compliment the previous positive preclinical efficacy
results observed in deterring transmission from SARS-CoV-2-infected
golden Syrian hamsters. The Company is continuing to progress the
development of its potential anti-viral therapy against COVID-19,
the disease caused by the SARS-CoV-2 virus.
To further evaluate the potential of its NITRICIL™ platform
technology as an intranasal treatment option for COVID-19, the
Company initiated preclinical in vivo studies evaluating the safety
and toxicity of berdazimer sodium when intranasally administered
via the SB019 formulation. The GLP study evaluated repeated dosing
with the candidate product SB019 (i.e., 5 times daily) for a period
of 14 days and concluded with a 7-day recovery period without drug
exposure. There were no treatment-related adverse events up to the
highest dose tested of 14 mg/day berdazimer sodium and the SB019
formulation was concluded to be well-tolerated under the conditions
of this study.
“These preclinical data support and further
strengthen the rationale behind developing SB019 as a potential
intranasal therapeutic against COVID-19. Through engagement with
the Coronavirus Treatment Acceleration Program, or CTAP, we have
made the FDA aware of our SB019 program and our intent to submit an
IND. We remain focused on the next steps to submit an IND and
initiate a Phase 1 study in humans no later than the second quarter
of 2022,” commented Paula Brown Stafford, President and Chief
Executive Officer of Novan.
Intranasal administration of berdazimer sodium marks a notable
extension to previously assessed routes of exposure preclinically
(e.g., dermal, oral, and intravenous) or clinically used in the
assessment of the safety and tolerability of berdazimer sodium,
across the Company’s numerous programs.
“Beyond our commitment to COVID-19, demonstrating that
berdazimer sodium can be well-tolerated when administered
intranasally unlocks numerous potential opportunities to assess the
efficacy of the NITRICIL™ platform technology in additional
indications, such as influenza, respiratory syncytial virus (RSV),
or other respiratory-related infections,” remarked Dr. Carri Geer,
Chief Technology Officer.
The Company has also completed additional dose-range finding
studies in SARS-CoV-2 infected golden Syrian hamsters through work
conducted at the Institute for Antiviral Research at Utah State
University. Significant reduction in the amount of virus in lung or
nasal tissue of animals directly inoculated and infected with
SARS-CoV-2 was observed and found to be dependent on both the
concentration and dosing regimen (e.g., once daily vs. twice daily)
of intranasally administered berdazimer sodium. These findings,
coupled with the promising safety data announced today for dosing
up to five times daily, will inform potential human clinical trial
design.
The Company continues to evaluate the potential progression of
SB019, subsequent to its anticipated Phase 1 study, subject to
obtaining additional financing or through strategic
partnerships.
About Novan
Novan, Inc. is a pre-commercial nitric oxide-based
pharmaceutical company focused on dermatology and anti-infective
therapies. We leverage our core synergies of science, capital,
resources and patient needs to create value by bringing new nitric
oxide-based medicines to market. Our goal is to create the world’s
leader in nitric oxide-based science, technology, and clinical
translation in support of delivering safe and efficacious therapies
using our proprietary nitric oxide-based technology platform,
NITRICIL™ to generate macromolecular New Chemical Entities (NCEs)
to treat multiple indications.
Forward-Looking StatementsAny
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 SB019 as an
anti-viral therapy against COVID-19, the potential safety and
tolerability of the Company’s product candidates, the Company’s
intention to pursue discussions with the FDA regarding a regulatory
pathway for SB019 and submit an IND 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, including the timing and outcome of
discussions with the FDA; 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; any operational or
other disruptions as a result of the COVID-19 pandemic; 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
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