Novan to Present Data from SB414 Phase 1b Atopic Dermatitis Clinical Trial at 3rd Inflammatory Skin Disease Summit
December 11 2018 - 8:00AM
Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today
announced that clinical results from the Company’s Phase 1b trial
with SB414 cream for the treatment of atopic dermatitis will be
presented at the 3rd Inflammatory Skin Disease Summit in Vienna,
Austria.
Tomoko Maeda-Chubachi, M.D., Novan’s Vice
President of Medical Dermatology, is scheduled to present “A
Topical Nitric Oxide-Releasing Cream SB414: Results of a Phase 1b
Double-Blind, Randomized, Vehicle-Controlled Study in Patients with
Mild-to-Moderate Atopic Dermatitis” during a poster session on
December 12, 2018 and an oral presentation on December 15,
2018.
“We are excited by the data we are presenting
with SB414 as it demonstrated trends suggestive of clinical
efficacy within only 2 weeks of treatment,” said Tomoko
Maeda-Chubachi, M.D., Novan’s Vice President of Medical
Dermatology. “Nitric oxide has the potential to impact multiple
mechanisms of atopic dermatitis and the results from this trial
give us the confidence to move forward with a more robust Phase 2
program.”
Top line results from Novan’s Phase 1b clinical
trial with SB414 for the treatment of atopic dermatitis were
previously announced in August and the Company intends to conduct a
Phase 2 trial.
About the Presentations
Title: “A Topical Nitric Oxide-Releasing Cream
SB414: Results of a Phase 1b Double-Blind, Randomized,
Vehicle-Controlled Study in Patients with Mild-to-Moderate Atopic
Dermatitis”Authors: Tomoko Maeda-Chubachi, Todd Durham, Stephen
Schleicher, Phoebe Rich, Emma Guttman-YasskyPresenting Author:
Tomoko Maeda-Chubachi, M.D., Novan’s Vice President of Medical
DermatologyPoster Presentation: Wednesday, December 12, 2018 at the
“Säulenhalle” (Level 1) and the “Science Café” (Level 0) between
6:00 p.m. – 9:00 p.m. Central European Standard TimeOral
Presentation: Saturday, December 15, 2018 from 1:00 p.m. – 1:30
p.m. Central European Standard Time
About Atopic Dermatitis
Atopic dermatitis, also known as atopic eczema,
is the most common chronic relapsing inflammatory skin disease,
affecting nearly 18 million people in the United States.1 Nearly
eighty percent of the atopic dermatitis population suffers from
mild-to-moderate disease and are treated with first-line
monotherapies, however, corticosteroids and calcineurin inhibitors
have side effects and are not well-suited for chronic use.2
Recently, the first biologic treatment for atopic dermatitis
targeting IL-4 and IL-13 was approved, but it is reserved for
patients with moderate-to-severe disease.
Stabilizing the disease and reducing the number
and severity of flares are the primary goals of current treatment.
The disease is characterized by intense itching, dry skin with red
papules and plaques, “weeping” clear fluid, crust and scaling.
Immune cells in the deep layers of skin release inflammatory
signals, causing an itchy rash. Scratching leads to defects in the
skin barrier function, allowing environmental triggers, such as the
bacteria Staphylococcus aureus, to penetrate the skin barrier and
further exacerbate the condition, triggering the “itch-scratch”
cycle. The density of S. aureus colonization has been correlated
with both the severity of atopic dermatitis lesions and the degree
of cutaneous inflammation.2
References
1IMS Health Disease Insights. “Atopic Dermatitis
– US.” June 2015.2Nakatsuji T., et al. J Invest Dermatol. 2016.
136(11):2192-2200.
About Novan
Novan, Inc. is a clinical-stage biotechnology
company focused on leveraging nitric oxide’s natural antiviral and
immunomodulatory mechanisms of action to treat dermatological and
oncovirus-mediated diseases. We believe that our ability to
conveniently deploy nitric oxide in a solid form, on demand and in
localized formulations allows us the potential to significantly
improve patient outcomes in a variety of diseases.
Forward-Looking Statements
This press release contains forward-looking
statements including, but not limited to, statements related to
pharmaceutical development of nitric oxide-releasing product
candidates, our intention to advance development of certain product
candidates, which is subject to our ability to obtain additional
financing or enter into strategic relationships to enable such
development, and the 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, risks and uncertainties 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 activities or additional trials; risks related to the
regulatory approval process, which is lengthy, time-consuming and
inherently unpredictable; our ability to obtain substantial
additional funding for the further advancement and development of
our product candidates, including the SB414 anti-inflammatory
program; our ability to identify and enter into strategic
relationships for the further development and potential
commercialization of our product candidates; and other risks
and uncertainties described in our annual report filed with the SEC
on Form 10-K for the twelve months ended Dec. 31, 2017, 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.
CONTACT:
(Investors & Media)Cole IkkalaDirector,
Investor Relations & Business Developmentcikkala@novan.com
Novan (NASDAQ:NOVN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Novan (NASDAQ:NOVN)
Historical Stock Chart
From Sep 2023 to Sep 2024