Novan, Inc. ("the Company" or "Novan") (Nasdaq: NOVN), today
announced the initiation of the B-SIMPLE4 pivotal Phase 3 clinical
study of SB206, a topical antiviral gel, for the treatment of
molluscum contagiosum (“molluscum”). Clinical sites are now open
for patient enrollment.
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.
“Molluscum affects millions of people each year,
a large percentage of those patients being children under the age
of ten. SB206 represents, what I believe to be, an incredible
opportunity to provide patients and caregivers an alternative
treatment to the options currently available, including
off-label prescriptions, procedures, and over-the-counter
treatments with no clinical data that would support a molluscum
indication and therefore have no proven clinical efficacy and
an unknown safety profile. I believe SB206 has potential in
addressing a significant unmet need in the treatment landscape of
molluscum and if approved, would provide patients with a treatment
benefit,” stated John Browning, M.D., F.A.A.D, F.A.A.P., MBA,
Assistant Professor of Pediatrics and Dermatology and the Chief of
Staff of Pediatric Dermatology at Texas Dermatology and Laser
Specialists, and a Principal Investigator in the B-SIMPLE 4
clinical study.
B-SIMPLE4 is a multi-center, double-blind,
randomized, vehicle-controlled study expected to enroll
approximately 750 patients (1:1 randomization), across 45 clinical
sites, who will be treated for 12 weeks with a follow-up visit at
Week 24. The primary endpoint for the study is proportion of
patients with complete clearance of all treatable molluscum lesions
at Week 12 (Intent-to-Treat or “ITT” population, where the analysis
assumes that patients with missing data at Week 12 are assessed as
treatment failures).
Paula Brown Stafford, Chairman, President and
Chief Executive Officer of Novan commented, “We are pleased to
initiate this study and are grateful for the dedication of our team
who continue to navigate the commencement of a clinical trial in
these unprecedented times with the COVID-19 pandemic. We worked
diligently to partner with clinical sites that are actively seeing
patients and are optimistic that we will reach our target to
complete enrollment in the first quarter of 2021.”
Topline results from the B-SIMPLE4 trial are
anticipated late in the second quarter of 2021, subject to the
targeted timing for completing enrollment and trial execution plan
which have been and may be further impacted by the COVID-19
pandemic.
Based on guidance the Company received during
its Type C meeting with the U.S. Food and Drug Administration
(“FDA”) and subsequently contained within the meeting minutes,
Novan is conducting B-SIMPLE4 a pivotal Phase 3 trial, which if
successful, could be supported by the previously completed
B-SIMPLE2 trial in a future New Drug Application (“NDA”). There are
currently no FDA-approved therapies for the treatment of molluscum.
Treatment choices for patients include in-office and often painful,
physician-administered scraping, freezing, burning and blistering
treatments. The only other choices, which lack proven clinical
efficacy and unknown safety profiles, are off-label prescriptions
and over-the-counter treatments. 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.
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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