Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today
announced positive topline efficacy and safety results for the
B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical
antiviral gel, for the treatment of molluscum contagiosum
(“molluscum”). Molluscum 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. The Company will host a video
webcast, today, June 11, 2021, at 8:00 a.m. ET (details below) to
discuss the results of the study.
“The positive results from B-SIMPLE4 represent a
transformational milestone for our employees, investors and most
importantly, people living with molluscum. The strong safety and
statistically significant efficacy results give us confidence as we
move forward in preparing a New Drug Application to potentially
bring SB206 to market and to patients in need of an effective
therapy,” commented Paula Brown Stafford, President and Chief
Executive Officer of Novan. “We owe a great deal of gratitude to
the collaborative efforts of our employees, partners, CROs, study
investigators and participating patients who have contributed or
participated in B-SIMPLE4.”
B-SIMPLE4 is a multi-center, double-blind,
randomized, vehicle-controlled study that exceeded its enrollment
target by randomizing 891 patients (1:1 randomization) in the
study, across 55 clinical sites. Patients were treated for up to 12
weeks with a follow-up visit at Week 24. The primary endpoint for
the study is the 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 considered treatment failures).
Summary of the primary and secondary endpoint
results are as follows:
|
B-SIMPLE4 |
SB206 (N=444) |
|
Vehicle (N=447) |
|
p-value |
Primary Endpoint: Complete Clearance of All
Lesions at Week 12 |
|
32.4% |
|
19.7% |
|
p<0.0001 |
|
Secondary Endpoint: Proportion Achieving a Lesion
Count of 0 or 1 at Week 12 |
|
43.5% |
|
24.6% |
|
p<0.0001 |
|
Secondary Endpoint: Proportion Achieving ≥90%
Clearance of Lesions at Week 12 |
|
43.0% |
|
23.9% |
|
p<0.0001 |
|
Secondary Endpoint: Complete Clearance of All
Lesions at Week 8 |
|
19.6% |
|
11.6% |
|
p=0.0014 |
|
|
|
|
|
|
|
Consistent with results from the Company’s Phase
2 and earlier Phase 3 studies, SB206 was found to be safe and well
tolerated. No treatment-related serious adverse events (“TEAE”)
were reported.
Tomoko Maeda-Chubachi, M.D., Ph.D., M.B.A.,
Senior Vice President, Medical at Novan added, “This is an exciting
day for both Novan, the treatment landscape of molluscum and the
millions of people, primarily children, affected every year. These
results are a testament to Novan’s solid execution of the SB206
clinical program and strategy, and our belief in the potential of
SB206 to provide patients with treatment benefit. With 32% of
patients experiencing total clearance at Week 12 and 43% of
patients with total clearance or one remaining lesion at Week 12, I
am pleased to say the data demonstrate SB206 can be a powerful
treatment option to shorten the duration of this contagious disease
with visible skin lesions that worry parents and caregivers.”
“I am proud to have been an investigator in this
pivotal study. The results are better than I could have imagined. I
am excited to potentially have a topical treatment that is safe and
effective in treating molluscum for my patients,” stated John
Browning, M.D., F.A.A.D, F.A.A.P., MBA, Adjunct Associate Professor
of Pediatrics and Dermatology at UT Health San Antonio and Baylor
College of Medicine, and a Principal Investigator in the B-SIMPLE4
study.
There are currently no U.S. Food and Drug
Administration (“FDA”) approved therapies for the treatment of
molluscum. The Company believes that SB206 as a topical, at-home,
self or 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 B-SIMPLE4 study,
please visit clinicaltrials.gov and reference identifier:
NCT04535531.
Conference Call and Webcast
Details
The Novan management will host a video webcast
presentation for investors, analysts, and other interested parties
today, Friday, June 11, 2021, at 8:00 a.m. ET. The live webcast
will be accessible on the Events page of the Investors section of
the Novan website, novan.com, and will be archived for 90 days.
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
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,” “intends” 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, including SB206, and the potential timing of an NDA
submission. 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;
the Company’s ability to obtain additional funding or enter into
strategic or other business relationships necessary or useful for
the further development or, following regulatory approval,
commercialization of the Company’s product candidates; 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; any operational or other disruptions as a
result of the COVID-19 pandemic; 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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