Novan, Inc. (“the Company” or “Novan”) (Nasdaq:NOVN) today
announced top-line efficacy results from its Phase 3 B-SIMPLE
program with SB206 for the treatment of molluscum contagiosum
(“molluscum”). Statistical significance was not achieved for the
primary endpoint in either B-SIMPLE1 or B-SIMPLE2, however multiple
sensitivity analyses are supportive and consistent across both
studies and support a potential path forward for the asset. The two
trials are ongoing, awaiting 24-week safety data, thus the top-line
results are for efficacy data only.
Summary of Top-Line Efficacy Data and SB206
Program:
- SB206 did not achieve statistically significant results for the
primary endpoint.
- B-SIMPLE2 was statistically significant for multiple
pre-specified sensitivity analyses.
- Similar analyses with B-SIMPLE1 demonstrated results are
reasonably consistent and supportive of B-SIMPLE2.
- Company intends to utilize B-SIMPLE2 as one of the confirmatory
trials for New Drug Application (“NDA”) submission, subject to
discussions with the U.S. Food and Drug Administration
(“FDA”).
- Company intends to support and confirm B-SIMPLE2 with an
additional confirmatory Phase 3 trial targeted to commence in April
2020, subject to additional funding and FDA feedback.
- Company’s timeline for NDA submission remains consistent and
targets potential NDA submission in the second quarter of 2021,
depending on outcome of discussions with FDA and confirmatory
results in the additional trial.
- Full efficacy and safety data from both trials, including the
prospectively planned safety evaluation ongoing through Week 24,
targeted to be available by March 2020.
The B-SIMPLE program consists of two multi-center, randomized,
double-blind, vehicle-controlled pivotal trials of topical nitric
oxide-releasing product candidate SB206 for the treatment of
molluscum in 707 patients aged 6 months and older, with a 2:1
(active:vehicle) randomization.
Primary endpoint – 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 Week 12 missing data are computed as treatment
failures):
Pivotal Trial |
SB206 |
Vehicle |
p-Value |
B-SIMPLE1 |
25.8%(n=236) |
21.6%(n=116) |
0.375 |
B-SIMPLE2 |
30.0%(n=237) |
20.3%(n=118) |
0.062 |
SB206 was near statistically significant for the
primary endpoint in B-SIMPLE2, and was statistically significant in
the secondary endpoint and several pre-specified sensitivity
analysis, which were included within the statistical analysis
plan:
Endpoint |
Population |
SB206 |
Vehicle |
p-Value |
Primary endpoint – complete |
Per-Protocol1 |
36.1%(n=194) |
23.3%(n=103) |
0.028 |
clearance at Week 12 |
Intent-to-Treat2 with Last Observation Carried Forward3 missing
data method |
30.8%(n=237) |
20.3%(n=118) |
0.044 |
Secondary endpoint – complete clearance at Week 8 |
Intent-to-Treat2 |
13.9%(n=237) |
5.9%(n=118) |
0.028 |
1. Per-protocol (“PP”) population: all patients
in the ITT population who completed the 12-week treatment period
and had no significant protocol deviations that impacted the
analyses of efficacy endpoints. 2.
Intent-to-Treat Population (“ITT”):
consists of all subjects who are randomized.
3. Last Observation Carried Forward (“LOCF”) method for handling
missing data: all patients randomized (ITT population) and where a
patient missed their Week 12 visit but had reported complete
clearance at their last collected lesion assessment, their last
visit lesion count is included in the analysis as complete
clearance at Week 12.
Following an assessment of the primary analysis
and pre-specified sensitivity analyses, Novan is able to
demonstrate through multiple statistical tests and trends that
B-SIMPLE1, while not statistically significant, is consistent with
and supportive of the B-SIMPLE2 trial and results.
Management, along with the Board of Directors,
continues to explore both financial as well as strategic options in
order to continue to progress SB206 for the molluscum indication.
As disclosed in the latest 10-Q filing, as of September 30, 2019,
the Company had $22.5 million in total cash, cash equivalents and
restricted cash, which is targeted to fund operations into the
first quarter of 2020, excluding the effect of any potential sales
of stock under the Company’s stock purchase agreement with Aspire
Capital Fund, LLC (“Aspire”), if available. The Company is working
to further address current operations with the aim of achieving a
reduction in near term cash expenditures. Substantial additional
funding will be required in order to continue to sustain business
operations.
The Company, along with the Board of Directors,
will provide a further business update in a timely manner and when
appropriate.
Select members of the management team will
attend the 7th Annual Dermatology Summit, taking place on January
12, 2020, as well as participate in additional meetings around the
38th Annual J.P. Morgan Healthcare Conference, taking place January
13-16, 2020, both in San Francisco, California.
Conference Call & Webcast (with
Slides)
Novan will host a webcast tomorrow, Friday,
January 3, 2020 at 8:30 am Eastern Time to present top-line
efficacy data and sensitivity analyses. There will not be any
Q&A and the Company intends to provide a more extensive
business update in the near term, upon receipt of the totality of
efficacy and safety data from the B-SIMPLE program.
U.S. toll free: |
+1 (844) 707-0661 |
International: |
+1 (703)
318-2240 |
Conference
ID: |
8358294 |
A live webcast will be accessible from the Events page of the
Company’s website at http://Events.Novan.com.
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 of full results of our
Phase 3 program to evaluate SB206 for the treatment of molluscum,
the outcome of discussions with the FDA regarding our B-SIMPLE
program, the timing for a third Phase 3 trial, the timing of
potential regulatory submissions, and our needs for funding.
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, the risk that
full results of the Phase 3 program will not be received timely or
will not be consistent with our expectations; the risk that the FDA
will not agree with our position that the B-SIMPLE2 results can be
used to support an NDA alongside results of a third confirmatory
trial; the risk that results from a third Phase 3 trial will not be
received timely or will not achieve significance sufficient to
support an NDA; our ability to obtain funding or enter into
strategic relationships on a timely basis, or at all, to enable a
third Phase 3 trial and to continue operations; our ability to
reduce cash expenditures; our ability to utilize the stock purchase
agreement with Aspire; risks and uncertainties in the clinical
development process, including, among others, length, expense,
ability to enroll patients, reliance on third parties, potential
for delays 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; risks related to the manufacture
of clinical trial materials; our ability to obtain additional
funding or enter into strategic relationships or other business
development necessary for the further development of our product
candidates; 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, 2018, 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.
CONTACT:
(Investors & Media)Cole IkkalaDirector,
Investor Relations, Communications & Business
Developmentcikkala@novan.com
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