Novan Provides SB206 Program and Business Update
February 06 2020 - 08:30AM
Novan, Inc. (“the Company” or “Novan”) (Nasdaq:NOVN) today provided
an update on several aspects of its Phase 3 B-SIMPLE program
(B-SIMPLE1 and B-SIMPLE2).
Novan has been granted a Type C meeting with the
U.S. Food and Drug Administration (“FDA”) on April 1, 2020. The
Type C Meeting is to seek FDA feedback on the proposal to conduct
one additional, well-controlled confirmatory study of SB206 to
support a future New Drug Application (“NDA”).
In the Company’s Phase 3 B-SIMPLE program with
SB206 for the treatment of molluscum contagiosum, the last subject
completed their final visit as part of the ongoing safety
evaluation through Week 24. Top-line efficacy results from this
program were announced on January 2, 2020, and full efficacy and
safety data, including data from the safety evaluation through Week
24, are targeted to be available in March 2020.
The safety profile of SB206 through the Week 12
visit was found to be favorable. Adverse events experienced in the
B-SIMPLE program were primarily mild to moderate and the only
treatment emergent adverse events (TEAE) reported in greater than
5% of subjects in the SB206 treatment arm were application site
pain and application site erythema. There were no treatment-related
serious adverse events reported in B-SIMPLE1 or B-SIMPLE2.
|
B-SIMPLE1 |
B-SIMPLE2 |
|
SB206 (n=235) |
Vehicle (n=116) |
SB206 (n=237) |
Vehicle (n=117) |
Subjects with at least one… |
TEAE |
115 (48.9%) |
36 (31.0%) |
120 (50.6%) |
29 (24.8%) |
TEAE leading to study drug discontinuation |
7 (3.0%) |
1 (0.9%) |
17 (7.2%) |
1 (0.9%) |
Maximum severity of TEAE at any visit |
Mild |
60 (25.5%) |
25 (21.6%) |
51 (21.5%) |
18 (15.4%) |
Moderate |
50 (21.3%) |
10 (8.6%) |
64 (27.0%) |
10 (8.5%) |
Severe |
5 (2.1%) |
1 (0.9%) |
5 (2.1%) |
1 (0.9%) |
Subjects treated with SB206 (n=472, integrated
safety population) experienced a lower occurrence of scarring
(3.8%), as determined by the investigator, through the Week 12
visit when compared to vehicle (n=233, integrated safety
population; 7.3%). Final safety profile and scarring assessments
will be updated through Week 24 and are targeted to be released in
March 2020.
Additional post-hoc analyses of efficacy data
were performed and identified discordant data in two-subject
households (two subjects randomized to the same treatment arm
within one household) in both studies. In two-subject households, a
greater clearance response rate in vehicle was experienced when
compared to SB206 in both B-SIMPLE1 and B-SIMPLE2. Both B-SIMPLE
studies were stratified across treatment groups by household,
two-subject or one-subject. The post-hoc analyses of the
one-subject households are summarized below:
Complete Clearance of all Molluscum Lesions at Week
12 (ITT, One-Subject Households
Only) |
Pivotal Study |
SB206 |
Vehicle |
p-Value |
B-SIMPLE1 |
28.7%(n=181) |
19.1%(n=89) |
0.116 |
B-SIMPLE2 |
29.0%(n=193) |
16.7%(n=96) |
0.025 |
In
the integrated primary analysis (combining data from B-SIMPLE1 and
B-SIMPLE2), a treatment effect of 7.0% was observed, which includes
subjects from one and two-subject households. When looking at
one-subject households only (excluding the data from the discordant
two-subject households), the treatment effect increases to 11.1%.
|
Primary Endpoint: Complete Clearance of all Molluscum
Lesions at Week 12 (ITT) |
Integrated Analysis |
SB206 |
Vehicle |
p-Value |
One and Two-Subject Households |
27.9%(n=473) |
20.9%(n=234) |
0.049 |
One-Subject Households Only |
28.9%(n=374) |
17.8%(n=185) |
0.005 |
Management, along with the Board of Directors,
continues to explore both financial as well as strategic options in
order to continue operations and to progress SB206 for the
molluscum indication, subject to funding and FDA feedback. The
Company intends to pursue financing, which may be dilutive,
non-dilutive or both, in the near future and intends to engage one
or more financial advisors to assist in this financial and
strategic process.
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, our needs for funding and our
intention to pursue financing and strategic alternatives.
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 or
complete a third Phase 3 trial and to continue operations; our
ability to reduce cash expenditures; our ability to utilize the
stock purchase agreement previously entered with Aspire Capital
Fund, LLC; 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 complete other strategic alternatives necessary to
continue our business and/or 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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