Novan to Present Clinical Data at Annual Meeting of the Society for Investigative Dermatology
22 April 2021 - 11:00PM
Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today
announced that data from the Company’s previously completed Phase 3
trials of SB206 for molluscum contagiosum (B-SIMPLE1, B-SIMPLE2)
will be presented at the Virtual Annual Meeting of the Society for
Investigative Dermatology (SID), being held May 3-8, 2021.
Integrated data from the B-SIMPLE1 and B-SIMPLE2
multicenter, randomized, double-blind, vehicle-controlled clinical
trials evaluating the Company’s topical nitric oxide–releasing
SB206 gel will be presented in an ePoster presentation on May 5,
2021 from 2:30 – 4:00 PM ET.
About the ePoster
Presentation
Title: BOTE (Beginning Of The End)
inflammation can be enhanced with SB206, a nitric oxide‐releasing
topical medication for molluscum contagiosumAbstract and
Poster Number: 400Authors: Tomoko Maeda-Chubachi, MD, PhD, MBA,
David Hebert, PhD, Elaine Siegfried, MD, Elizabeth Messersmith,
PhDInteractive Poster/Exhibitor Session I: Patient Targeted
ResearchDate and Time: May 5, 2021 from 2:30 – 4:00 PM ET ePoster
Talks: Available on-demand from May 3-May 31, 2021
For more information about the conference,
please visit www.sidannualmeeting.org.
About
Molluscum
Molluscum contagiosum is a common, contagious
skin infection caused by the molluscipoxvirus, affecting
approximately six million people in the U.S. annually, with the
greatest incidence in children aged one to 14 years. Infected
children typically present with 10 to 30 painless, yet unsightly
lesions, and, in severe cases, they can have around 100 lesions.
Due to the largely pediatric nature of the disease, parents are the
caregivers for these children, in most cases, and tend to seek
treatment. There are no U.S. Food and Drug Administration (“FDA”)
approved therapies for molluscum, and, upon seeking treatment,
caregivers are faced with potentially painful in-office,
dermatologist-administered physical procedures or cantharidin, or
recommended off-label prescriptions and over-the-counter products.
More than half of the patients diagnosed with molluscum are
untreated and over 30% of those treated receive an off-label
prescription with no molluscum indication or proven clinical
efficacy. The average time to resolution is 13 months, however,
some children experience lesions that may not resolve in 24 months.
Further dissemination of this highly-contagious disease is common,
and transmission to other children living in the household is
reported to be 41%. There is a significant unmet need in the
molluscum treatment landscape.
About Novan
Novan, Inc. is a clinical development-stage
biotechnology company focused on leveraging its proprietary nitric
oxide (NO) based technology platform, NITRICIL™ to generate
macromolecular New Chemical Entities (NCEs) to treat multiple
indications in dermatology, men’s and women’s health, infectious
diseases and gastroenterology conditions with significant unmet
needs. The Company’s lead product candidate, SB206, a topical
antiviral gel, for the treatment of molluscum contagiosum, is
currently being evaluated in the B-SIMPLE4 pivotal Phase 3 clinical
study. The Company believes that SB206 as a topical, at-home,
caregiver-applied therapy with a rapid treatment benefit, if
approved, would address an important patient-care need for the
treatment of molluscum.
Forward-Looking Statements
Any statements contained in this press release
or in the announced presentation 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,” “may,” “plan,” “potential,” “will,” 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 and the Company’s intention to advance development of
certain product candidates. 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, which may not prove successful in
demonstrating proof-of concept, or may show adverse toxicological
findings, and even if successful may not necessarily predict that
subsequent clinical trials will show the requisite safety and
efficacy of the Company’s product candidates; any operational or
other disruptions as a result of the COVID-19 pandemic, including
any delays or disruptions to the conduct of the B-SIMPLE4 study;
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, including the risk that the Company’s
product candidates may not be approved or that additional studies
may be required for approval or other delays may occur and that the
Company may not obtain funding sufficient to complete the
regulatory or development process; 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 risk that disruptions at the
U.S. Food and Drug Administration or other agencies could cause
such agencies to cancel or postpone meetings or otherwise impact
the ability of such agencies to provide regulatory guidance or
feedback or timely review and process the Company’s regulatory
submissions, all of which could have a material adverse effect on
the Company’s business; risks related to the manufacture of raw
materials, including the Company’s active pharmaceutical ingredient
and drug product components utilized in clinical trial materials,
including failure to transfer technology and processes to third
parties effectively or failure of those third parties to obtain
approval of and maintain compliance with the U.S. Food and Drug
Administration or comparable regulatory authorities; 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; and other risks and uncertainties described in
the Company’s annual report filed with the SEC on Form 10-K for the
twelve months ended December 31, 2020, and in the Company’s
subsequent filings with the SEC. Such forward-looking statements
speak only as of the date of this press release or the announced
presentation, as applicable, 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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