Novan Announces Positive Preclinical Data in SB019 COVID-19 Anti-Viral Therapy Program
June 10 2021 - 08:30AM
Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today
announced positive preclinical results with berdazimer sodium in a
SARS-CoV-2 transmission model in golden Syrian hamsters. In light
of these promising results, the Company is exploring opportunities
to develop an anti-viral therapy against COVID-19, the disease
caused by the SARS-CoV-2 virus, both internally and potentially
through strategic partnerships for this program.
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
efficacy of berdazimer sodium to reduce viral burden in infected
animals and to deter viral transmission to uninfected animals. The
work was conducted at the Institute for Antiviral Research at Utah
State University. Results from two separate studies independently
demonstrated the ability of berdazimer sodium to prevent
progression of infection into the lungs after transmission,
significantly limiting severity of disease in this model. The
intranasal treatment was well-tolerated during the preclinical in
vivo studies, and no treatment-related adverse events were
observed.
“These preclinical data are encouraging and
provide the basis that we were looking for to support continuing
down the development path for SB019. We are exploring avenues to
interact with the FDA to expedite or streamline a development
program for a potential intranasal treatment option for COVID-19,”
commented Paula Brown Stafford, President and Chief Executive
Officer.
SARS-CoV-2 infected animals were co-housed with healthy animals
to induce infection via animal-to-animal transmission. The effect
of a repeat, once daily intranasal treatment regimen with
berdazimer sodium at various doses was assessed versus placebo
controls. The endpoints included nasal and lung tissue viral count,
in addition to body weight changes, an indicator of disease
severity.
The Company observed a dose-dependent, statistically significant
reduction (P<0.0001) in the amount of virus in the lungs of
animals treated with berdazimer sodium concentrations as low as 2
mg/mL compared to placebo-treated controls. The effect was observed
after co-habitation with infected hamsters who were also treated
with berdazimer sodium. The average amount of virus in the lungs
was reduced by greater than 4 logs (>99.99%) with more than half
of the animals having no detectable virus in lung tissue at
all.
Catalent, a leading global provider of advanced delivery
technologies, development and manufacturing solutions for drugs,
biologics, cell and gene therapies, and consumer health products,
continues to support Novan’s CMC efforts and development of an
intranasal formulation, SB019, for use in the Company’s COVID-19
program.
Preclinical tolerability and toxicology studies were conducted
at a third-party research organization to inform product
development at Catalent. The initial studies support the
established safety profile of berdazimer sodium and suggest
favorable tolerability when administered intranasally after repeat
dosing.
Further, preclinical dose-range finding studies are being
conducted to inform potential human clinical trial design and
dosing regimen.
Based on the scientific literature, the Company’s previously
reported in vitro results and the in vivo results announced today,
Novan believes that nitric oxide may inhibit viral replication by
disrupting protein function critical for viral replication and
infection through generation of reactive intermediates. The Company
plans to submit a request to the FDA to determine an appropriate
path to bring a new potential treatment option to patients, as
quickly as possible. The Company is evaluating its strategy to
submit an IND for the purposes of advancing its SB019 product
candidate, subject to regulatory guidance, successful completion of
IND-enabling toxicology studies and obtaining additional financing
or strategic partnering.
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 SB019 as an
anti-viral therapy against COVID-19,the potential safety and
tolerability of the Company’s product candidates, the Company’s
plan 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, as well as completion of the additional
preclinical studies described above; 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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