Novan Reports Topline Results from SB204 Phase 3 Pivotal Trials
January 27 2017 - 9:05AM
Topical Acne Product Candidate Achieves
Statistical Significance on All Three Co-Primary Endpoints in One
Trial, Demonstrates Statistical Significance on Only One of Three
in the Second
Novan, Inc. (NASDAQ:NOVN) today announced top-line results
from the Company’s two, replicate Phase 3 pivotal clinical trials
for SB204 in the treatment of acne vulgaris. In the intent-to-treat
analysis, Novan’s topical nitric oxide-releasing product candidate
SB204 demonstrated statistical significance (p<0.05) compared to
vehicle on all three co-primary endpoints in NI-AC302, but
demonstrated statistical significance on only one of three
co-primary endpoints in NI-AC301. The three co-primary endpoints
included the absolute changes in inflammatory and non-inflammatory
lesion counts and proportion of patients achieving success on the
Investigator Global Assessment, or IGA, at week 12. Success was
defined as an improvement of at least two grades in the IGA score
from baseline and an IGA score of 0 or 1, or “clear” or “almost
clear.”
In these two Phase 3 multi-center, randomized,
double-blinded, vehicle-controlled, parallel group pivotal clinical
trials, NI-AC301 and NI-AC302, a total of 2,639 patients ages 9 and
older with moderate to severe acne were enrolled across a total of
110 sites in the United States, randomized in a 1:1 ratio to SB204
Gel 4% topically once-daily or vehicle gel topically once-daily and
treated for 12 weeks. No new safety signals were observed and both
treatments were generally safe and well tolerated, with less than
2% of patients discontinuing due to treatment-emergent adverse
events in each trial. Summary statistics are based on the use of a
multiple imputation methodology for missing data.
- The absolute change from baseline in the number of
non-inflammatory lesions in NI-AC301 was -15.4 for SB204 and -13.4
for vehicle (p=0.030), and in NI-AC302 was -14.9 for SB204 and
-12.3 for vehicle (p=0.001).
- The absolute change from baseline in the number of inflammatory
lesions in NI-AC301 was -12.1 for SB204 and -11.1 for vehicle
(p=0.114), and in NI-AC302 was -12.9 for SB204 and -10.6 for
vehicle (p<0.001).
- The proportion of patients with IGA success in NI-AC301 was
13.4% for SB204 and 13.8% for vehicle (p=0.866), and in NI-AC302
was 18.9% for SB204 and 14.3% for vehicle (p=0.032).
The secondary endpoints for percent change in
lesion counts are shown in the table below for each study along
with the proportion of subjects achieving IGA success.
|
|
NI-AC301 |
NI-AC302 |
|
|
Non-Inflammatory Lesion Reduction
|
|
|
|
|
SB204, 4% |
39 |
%* |
42 |
%* |
|
|
Vehicle |
34 |
% |
34 |
% |
|
|
Inflammatory Lesion Reduction |
|
|
|
|
SB204, 4% |
46 |
% |
51 |
%* |
|
|
Vehicle |
43 |
% |
41 |
% |
|
|
IGA Success |
|
|
|
|
SB204, 4% |
13.4 |
% |
18.6 |
%* |
|
|
Vehicle |
13.8 |
% |
14.3 |
% |
*p<0.05 |
|
|
|
|
“While we are pleased with the results of the
NI-AC302 trial that met the regulatory requirement for
statistically significant efficacy of SB204, we are disappointed
with the discordant results of NI-AC301. Our team has not yet
received the full data set and we intend to provide an update on
the SB204 program after our complete analysis,” said Nathan Stasko,
PhD, President and CEO of Novan. “Despite these discordant results,
we believe in the potential of nitric oxide’s multiple,
well-documented mechanisms of action and the data we have recently
generated for our SB206 anti-viral and SB414 anti-inflammatory
product candidates. We continue to look forward to near term
clinical results from our SB208 anti-fungal program in the second
quarter of 2017 and advancing our pipeline of innovative therapies
for patients suffering from skin diseases.”
The Company believes that its cash on hand is
sufficient to fund operations at least through the end of 2017, of
which the allocation of capital will be dependent upon further
assessment of the SB204 Phase 3 trial results and data from other
platform programs.
About Novan
Novan, Inc. is a late-stage pharmaceutical
company focused on redefining the standard of care in dermatology
through the development and commercialization of innovative
therapies using the Company’s nitric oxide-releasing platform.
Nitric oxide plays a vital role in the natural immune system
response against microbial pathogens and is a critical regulator of
inflammation. Our ability to harness nitric oxide and its multiple
mechanisms of action has enabled us to create a platform with the
potential to generate differentiated, first-in-class product
candidates. We are rapidly advancing programs in five
dermatological conditions with significant unmet medical need. We
believe that our ability to conveniently deploy nitric oxide on
demand in topical formulations allows us the potential to
significantly improve patient outcomes in a variety of skin
diseases and positions us to be a commercially successful leader in
the dermatology market.
For more information, visit the Company’s
website at www.Novan.com.
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, including further development of SB204, and future
prospects of our business. 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 additional analyses of
the data from the Phase 3 trial may be inconsistent with previously
announced top-line results; uncertainties and risks in the clinical
development process generally, including, among others, length,
expense, ability to enroll patients, reliance on third parties and
that results of earlier research and preclinical or clinical trials
may not be predictive of results, conclusions or interpretations of
later research or trials; the risk that we could incur additional
expenses in connection with further analyses of any of our
clinical-stage programs and whether we will be able to obtain
additional funding when needed; and other risks and uncertainties
described in our prospectus dated Sept. 20, 2016, filed with the
Securities and Exchange Commission, or SEC, in our quarterly report
filed with the SEC on Form 10-Q for the three months ended Sept.
30, 2016, and in any 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)
Sean Andrews, Senior Director of Investor Relations
Novan, Inc.
919-627-6847
investors@novan.com
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