Novan Presents Preclinical Data from Inflammatory Skin Diseases Program
April 27 2017 - 9:05AM
Novan, Inc. (“the Company” or “Novan”) (NASDAQ:NOVN) today
announced that data from two preclinical studies with SB414, a
nitric oxide-releasing cream in development for the treatment of
inflammatory skin diseases such as psoriasis and atopic dermatitis,
will be presented at the 76th Annual Meeting of the Society for
Investigative Dermatology in Portland, Oregon. In a psoriasis mouse
model, SB414 significantly (p<0.05) reduced composite psoriasis
scores and also inhibited the production of pro-inflammatory
cytokines, including interleukin-17, or IL-17a and IL-17f.
Additionally, in two in vivo models that assess critical components
of atopic dermatitis disease pathology, SB414 displayed potent
anti-staphylococcal activity and dose-dependent inhibition of
inflammation comparable to betamethasone, a mid-potency
corticosteroid used to treat eczema patients.
“Both psoriasis and atopic dermatitis patients
are in need of new topical therapeutic options,” said Alan Menter,
M.D., program director of dermatology residency and chair of
dermatology for Baylor University, and dermatologist at Texas
Dermatology Associates, P.A. “I am specifically intrigued by
SB414’s effect on the proven psoriatic pathway IL23/IL17. The
majority of new drugs for psoriasis over the past 12 years have
been limited to systemic and biologic therapies. Approximately six
million people in the United States, or 80% of all psoriasis
sufferers, with mild to moderate disease have been treated purely
with topical agents and have yet to benefit from our deeper
understanding of the pathophysiology of the disease. These
preclinical results give hope that there may be a therapeutically
valuable, novel topical treatment that downregulates many of the
key cytokines in the immunological cascade of psoriasis.”
Novan plans to submit an Investigational New
Drug application, or IND, to the U.S. Food and Drug Administration,
or FDA, for SB414 in the second quarter of 2017 and initiate
clinical development of the nitric oxide-releasing cream with a
Phase 2 proof-of-concept trial in patients with mild-to-moderate
psoriasis.
About the Presentations
Abstract Number:
703Title: “Preclinical evidence for nitric
oxide-releasing SB414 in a psoriasis animal
model”Authors: S Hollenbach, K McHale, M Martin, R
Doxey, J Ross and N StaskoPoster PresentationPresenter:
Stanley HollenbachDate and Time: Thursday, April 27, 2017, 10:15
a.m. – 12:15 p.m. Pacific TimeSession: Poster Session I, Exhibit
Hall A
Abstract Number:
709Title: “Nitric oxide-releasing topical
therapeutic agent for atopic dermatitis”Authors: K
McHale, J Gil, S Davis, S Hollenbach and N StaskoOral
PresentationPresenter: Stanley HollenbachDate and Time: Thursday,
April 27, 2017, 3:38 p.m. Pacific TimeSession: Mini symposium:
Interdisciplinary Spotlight: Frontiers in Atopic Dermatitis, B113 -
116
Poster PresentationPresenter: Stanley
HollenbachDate and Time: Thursday, April 27, 2017, 10:15 a.m. –
12:15 p.m. Pacific TimeSession: Poster Session I, 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, , delays
associated with the submission or effectiveness of an IND, delays
in initiating clinical trials, 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;
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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