Novan Announces Presentation of Two Posters at the 2022 Winter Clinical Dermatology Conference
14 Janeiro 2022 - 11:05AM
Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today
announced that data from the Company’s completed Phase 2 and Phase
3 clinical studies of berdazimer 10.3% gel (previously referred to
as SB206) for molluscum contagiosum will be presented at the 2022
Winter Clinical Dermatology Conference, being held January 14-19,
2022, in Koloa, Hawaii.
Berdazimer 10.3% gel, containing new chemical
entity berdazimer (sodium), is in late-stage development and poised
as a first-in-class topical controlled-nitric oxide releasing
medication for the treatment of molluscum contagiosum, a highly
contagious viral skin disease affecting an estimated 6 million
people in the US, mostly children, if approved. There is currently
no US Food & Drug Administration (FDA) approved medication
indicated for the treatment of molluscum. If approved, the Company
believes berdazimer 10.3% gel would offer those infected with
molluscum a potential prescription therapeutic approach that could
allow patients and/or caregivers to directly apply treatment gel to
molluscum lesions.
The data presented at Winter Clinical features
the efficacy and safety data from the Phase 2 study as well as
Beginning of the End (BOTE) sign data collected from three Phase 3
studies. The latter represents a clinical sign of inflammation and
imminent resolution of molluscum lesions that has never been
prospectively studied in a molluscum clinical trial.
About the Poster
Presentations:
Title: BOTE (Beginning Of The End) is a Clinical
Sign of Molluscum Contagiosum Resolution Enhanced by SB206, an
Investigational Nitric Oxide–Releasing Topical MedicationAuthors:
Tomoko Maeda-Chubachi, MD, PhD, MBA, Martina Cartwright, PhD,
Elaine Siegfried, MD
Title: Results of Phase 2 Study Evaluating the
Efficacy and Safety of SB206, Topical Berdazimer Sodium Gel, in
Subjects with Molluscum ContagiosumAuthors: John Browning, MD,
Adelaide Hebert, MD, Carolyn Enloe, MPH, Tomoko Maeda-Chubachi, MD,
Martina Cartwright, PhD
Posters appear throughout the meeting within the
Poster Gallery in the Grand Promenade of the Grand Hyatt Kauai.
For more information about the conference, visit:
https://fallclinical.health/
About Novan
Novan, Inc. is a pre-commercial nitric
oxide-based pharmaceutical company focused on dermatology and
anti-infective therapies. We leverage our core synergies of
science, capital, resources and patient needs to create value by
bringing new nitric oxide-based medicines to market. Our goal is to
create the world’s leader in nitric oxide-based science,
technology, and clinical translation in support of delivering safe
and efficacious therapies using our proprietary nitric oxide-based
technology platform, NITRICIL™ to generate macromolecular New
Chemical Entities (NCEs) to treat multiple indications.
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,” 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, such as berdazimer 10.3% gel (SB206) for molluscum
contagiosum, and the potential benefits of berdazimer 10.3% gel, if
approved. 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 related to the regulatory approval process, which
is lengthy, time-consuming and inherently unpredictable, including
the risk that the FDA will not agree with the Company’s approach to
a potential NDA submission, that the Company’s product candidates
may not be approved or that additional studies may be required for
approval or other delays may occur, that the Company may not have
sufficient quantities of drug substance and/or drug product to
support regulatory submissions and that the Company may not obtain
funding sufficient to complete the regulatory or development
process; the Company’s limited experience as a company in obtaining
regulatory approvals and commercializing pharmaceutical products
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; the Company’s ability to obtain additional funding or
enter into strategic or other business relationships necessary or
useful for the further development or commercialization of the
Company’s product candidates; the Company’s reliance on
arrangements with third parties to support its operations and its
development, manufacturing and commercialization 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 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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