Novan Presents Safety Data for SB204 Program
April 27 2017 - 9:14AM
Novan, Inc. (“the Company” or “Novan”) (NASDAQ:NOVN) today
announced that pharmacokinetic data for SB204, a once-daily,
topical monotherapy for the treatment of acne vulgaris, will be
presented at the 76th Annual Meeting of the Society for
Investigative Dermatology in Portland, Oregon. In three
pharmacokinetic clinical trials conducted in patients with moderate
to severe acne to assess systemic exposure following topical
application of SB204, there was no detectable systemic exposure to
markers for nitric oxide exposure in adults or adolescents treated
with SB204 under maximal use conditions. Maximal use conditions
were defined as application of SB204 Gel or vehicle to 17% of body
surface area, or the face, upper chest, upper back and shoulders,
of patients with moderate to severe acne. In general, all doses of
SB204 were well tolerated and not associated with any significant
safety issues in these trials.
“These results are another series of strong data
points contributing to the evolving understanding of the safety of
SB204,” said Lawrence Eichenfield, M.D., chief of pediatric and
adolescent dermatology at Rady Children's Hospital–San Diego, vice
chair of the Department of Dermatology and professor of dermatology
and pediatrics at the University of California, San Diego School of
Medicine. “The lack of detectable systemic exposure, even in
adolescents, further demonstrates the appropriateness of SB204 for
a wide range of acne patients."
Novan expects to report additional safety data
from the long-term safety trial, NI-AC303, currently ongoing in
eligible patients who completed 12 weeks of treatment in the
Company’s Phase 3 pivotal trials with SB204 in the third quarter of
this year. As previously announced, Novan intends to pursue a
pre-submission meeting with the U.S. Food and Drug Administration,
or FDA, to discuss the entirety of the SB204 development program in
the third quarter of 2017, which could lead to a new drug
application, or NDA, submission targeted in the first quarter of
2018.
About the Presentation
Abstract Number:
257Title: “Pharmacokinetics of SB204 in subjects
with acne vulgaris”Authors: M Rico, J DuBois, C
Canabrio, J Scoggin and R Guttendorf Presenter: M. Joyce
RicoDate and Time: Friday, April 28, 2017, 11:30 am – 1:30 p.m.
Pacific TimeSession: Poster Session II, Exhibit Hall A
About Novan
Novan, Inc. is a late-stage pharmaceutical
company focused on redefining the standard of care in dermatology
through the development and commercialization of innovative
therapies using the Company’s nitric oxide-releasing platform.
Nitric oxide plays a vital role in the natural immune system
response against microbial pathogens and is a critical regulator of
inflammation. Our ability to harness nitric oxide and its multiple
mechanisms of action has enabled us to create a platform with the
potential to generate differentiated, first-in-class product
candidates. We are rapidly advancing programs in five
dermatological conditions with significant unmet medical need. We
believe that our ability to conveniently deploy nitric oxide on
demand in topical formulations allows us the potential to
significantly improve patient outcomes in a variety of skin
diseases and positions us to be a commercially successful leader in
the dermatology market.
For more information, visit the Company’s
website at www.Novan.com.
Forward-Looking Statements
This press release contains forward-looking
statements including, but not limited to, pharmaceutical
development of nitric oxide-releasing product candidates and 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, uncertainties
and risks in the clinical development process, including, among
others, length, expense, ability to enroll patients, reliance on
third parties, and that results of earlier research and preclinical
or clinical trials may not be predictive of results, conclusions or
interpretations of later research or trials; the lengthy and
unpredictable nature of the U.S. Food and Drug Administration’s
drug approval process, including the risk that the FDA is not
amenable to our plan for SB204 or requires additional studies or
information before we can submit our NDA, the risks that we are
delayed in making an NDA submission, the FDA does not accept our
submission for filing, disagrees with our analysis of endpoints or
that the FDA requires additional studies to support the submission
and the risk the FDA does not approve our NDA or approves our NDA
with limitations or subject to additional studies; whether we will
be able to obtain additional funding when needed; and other risks
and uncertainties described in our annual report filed with the
Securities and Exchange Commission, or SEC, on Form 10-K for the
twelve months ended Dec. 31, 2016, and in any 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)
Novan, Inc.
919-627-6847
investors@novan.com
(Media)
Deb Holliday
Pascale Communications, LLC
412-877-4519
deb@pascalecommunications.com
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