Novan Announces First Patient Enrolled and Dosed in B-SIMPLE4 Pivotal Phase 3 Study of SB206 for Treatment of Molluscum
September 03 2020 - 9:05AM
Novan, Inc. ("the Company" or "Novan") (Nasdaq: NOVN), today
announced the first patient has been enrolled and dosed in its
B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical
antiviral gel, for the treatment of molluscum contagiosum
(“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.
“I believe that the design of the B-SIMPLE4
study positions us well to fully evaluate SB206 for the treatment
of molluscum,” commented Elizabeth Messersmith, Ph.D, Senior Vice
President and Chief Development Officer of Novan. “We are
encouraged by the trends in efficacy as well as the safety profile
SB206 has demonstrated to-date and look forward to continuing to
advance development of this important program where there remains
no FDA approved treatment.”
Completion of patient enrollment is targeted for
the first quarter of 2021. Topline results from the B-SIMPLE4 trial
are anticipated in the second quarter of 2021, subject to the
targeted timing and trial execution plan which have been and may be
further impacted by the COVID-19 pandemic.
There are currently no FDA-approved therapies
for the treatment of molluscum. The Company believes that SB206 as
a topical, at-home, caregiver-applied therapy with a rapid
treatment benefit, if approved, would satisfy an important
patient-care need for the treatment of molluscum.
For more information about the trial, please
visit clinicaltrials.gov and reference identifier: NCT04535531.
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 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 nitric oxide’s
naturally occurring anti-microbial and immunomodulatory mechanisms
of action to treat a range of diseases with significant unmet
needs. We believe that our ability to deploy nitric oxide in a
solid form, on demand and in localized formulations allows us the
potential to improve patient outcomes in a variety of dermatology,
women’s health and gastrointestinal 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 and our intention to advance development of certain
product candidates, including the timing, enrollment demand and
progress of our Phase 3 program to evaluate SB206 for the treatment
of molluscum and the timing of anticipated top-line results.
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, 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 our product
candidates may not be approved or that additional studies may be
required for approval or other delays may occur and that we may not
obtain funding sufficient to complete the regulatory or development
process; our ability to obtain additional funding or enter into
strategic or other business relationships necessary or useful for
the further development of our product candidates; the risk that
disruptions at the FDA 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 our regulatory submissions, all of which could
have a material adverse effect on our business; risks related to
the manufacture of clinical trial materials; any operational or
other disruptions as a result of the COVID-19 pandemic, including
any delays or disruptions to the enrollment in and conduct of the
B-SIMPLE4 Phase 3 trial; and other risks and uncertainties
described in our annual report filed with the SEC on Form 10-K for
the twelve months ended December 31, 2019, as amended, 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.
INVESTOR AND MEDIA CONTACT:
Jenene ThomasJTC Team,
LLC833-475-8247NOVN@jtcir.com
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