MENLO PARK, Calif.,
June 1, 2017 /PRNewswire/
-- BioPharmX Corporation (NYSE MKT: BPMX) today released
comprehensive phase 2b clinical data showing that its
investigational acne drug BPX-01 2% reduces the number of
inflammatory lesions in acne patients by 59% versus 44% in vehicle
with no serious drug-related adverse side effects experienced– and
suggesting it may also lessen the severity of lesions.
The phase 2b study was a randomized, double-blind, three-arm,
vehicle-controlled, dose-finding study to assess the efficacy and
safety of BPX-01 for the treatment of acne vulgaris. The
multi-center study evaluated two concentrations of BPX-01 (1% and
2% minocycline) and vehicle in 226 subjects, aged 9 to 40, with
moderate-to-severe inflammatory, non-nodular acne
vulgaris. The study showed the 2% concentration was
statistically superior in reducing the number of inflammatory
lesions in patients with moderate-to-severe acne, compared to
vehicle (59% vs. 44% at week 12).
The phase 2b study also measured reduction in a five-point
investigator's global assessment (IGA) scale. The percentage
of subjects treated with BPX-01 2% who showed at least a two-grade
improvement and an IGA of clear or almost clear, a secondary
efficacy endpoint in the study was 25 percent. Although these
secondary endpoint results were not statistically significant,
BioPharmX observed in the BPX-01 2% arm a clear numerical trend
compared to vehicle. The phase 2b research was not powered to
measure IGA statistical significance. Because IGA will be a
required co-primary endpoint in phase 3, the study will be powered
to measure statistical significance of IGA with at least a
two-grade improvement and a score of clear or almost clear.
Researchers also found that no subjects experienced serious
treatment-related adverse side effects. A PK study showed that
plasma minocycline levels following topical use were undetectable
in all but a single subject, whose level – 42 ng/mL – was one-tenth
of that measured after a standard adult dosage of oral
minocycline.
"The results of this research are encouraging and offer promise
to millions of patients suffering from moderate-to-severe acne, and
to their dermatologists, who have long wanted additional effective
topical alternatives to oral antibiotics," said Dr. Ted Lain, board-certified dermatologist and an
investigator in the BPX-01 study.
BPX-01 is the first hydrophilic topical gel with fully
solubilized minocycline that can penetrate the skin to deliver the
antibiotic to where acne develops in the pilosebaceous unit. It is
designed for the treatment of moderate-to-severe acne.
"We are very pleased about the initial efficacy we are seeing in
lesion reduction with BPX-01 2% and look forward to end-of-phase 2
discussions with the Food and Drug Administration," said
Anja Krammer, co-founder and
president of BioPharmX. "We believe BPX-01 2% offers a
potential opportunity to bring to market a much-needed alternative
for the treatment of moderate-to-severe acne."
The comprehensive study results will be presented today at a
"State of Acne" symposium in New York
City.
The symposium will feature presentations from preeminent
dermatology thought leaders, including principal investigators in
the phase 2b study of BPX-01.
Speakers scheduled to present at the event include:
- Hilary Baldwin, M.D.,
SUNY; Medical Director, Acne Treatment
& Research Center in New York
City
- Jim Leyden, M.D., Professor
Emeritus of Dermatology, University of
Pennsylvania
- Scott Herron, M.D.,
Ph.D., Medical Director, BioPharmX
- Neal Bhatia, M.D., Therapeutics
Clinical Research, San Diego
- Andrew Alexis, M.D., Chairman,
Department of Dermatology at Mount Sinai System in New York City
- Ted Lain, M.D., Board-certified
dermatologist, Austin, Texas
BioPharmX will present its comprehensive results at the
symposium at 8:30 a.m. ET. The event
will be (both) webcast live and archived for 90 days at
http://www.biopharmx.com/media/#events.
Summary of phase 2b data
Primary - Inflammatory Lesions
In the phase 2b study,
the 2% concentration achieved statistical significance for its
reduction in inflammatory lesion count at week 12, the primary
endpoint, as well as inflammatory lesion reduction
percentage. The 1% concentration was not statistically
significant on the primary endpoint of lesion count reduction or
lesion reduction percentage. Analysis reflects the intent to
treat (ITT) population of 219 and imputation for the last
observation carried forward (LOCF) was applied.
Study
Arm
|
Subjects
|
Mean Change in
Inflammatory Lesions
|
Percent
Reduction in
Inflammatory Lesions
|
BPX-01
2%
|
n=72
|
-15.4
(p=0.0352)
|
58.5%
(p=0.0256)
|
BPX-01
1%
|
n=73
|
-15.5
(p=0.0543)
|
54.4%
(p=0.0765)
|
Vehicle
|
n=74
|
-11.2
|
43.8%
|
Results at Week 12
Secondary - Investigator's Global Assessment (IGA)
A
two-grade reduction in IGA score to clear "0" or almost clear "1"
will be required in the company's phase 3 study, therefore
BioPharmX included IGA as a secondary endpoint in its phase 2b
study to help inform the design of the pivotal phase 3
program. The trial was not powered for statistical
significance for IGA, however, BioPharmX observed a clear numerical
trend in the BPX-01 2% arm compared to vehicle. Comprehensive
results include imputation for the LOCF, consistent with primary
endpoint analysis.
Study
Arm
|
Subjects
|
Proportion of
patients with at least a 2-grade reduction AND clear or almost
clear
|
BPX-01
2%
|
n=72
|
25.0%
(p=0.5445)
|
BPX-01
1%
|
n=73
|
20.5%
(p>0.9999)
|
Vehicle
|
n=74
|
17.6%
|
Safety
BPX-01 appeared to be generally well tolerated.
There were no serious drug-related adverse events (AEs). The most
common adverse events reported across all three treatment arms were
upper respiratory infection (2.7%), nasopharyngitis (2.7%) and mild
headache (1.8%). The BPX-01 phase 2b study measured
minocycline plasma concentrations based on a limit of
quantification (LOQ) of 10 ng/ML. No detectable levels of
minocycline were found in the bloodstream of patients using the
topical minocycline with the exception of a single patient whose
plasma minocycline level was 42 ng/mL with no reported adverse
events.
Minocycline Plasma
Concentrations (ng/mL)
|
|
Baseline
|
Week 4
|
Week 12
|
BPX-01 2%
|
BLOQ
|
BLOQ
|
BLOQ*
|
BPX-01 1%
|
BLOQ
|
BLOQ
|
BLOQ
|
Vehicle
|
BLOQ
|
BLOQ
|
BLOQ
|
*One patient of BPX-01 2% measured 42 ng/mL, but demonstrated no
AEs
BLOQ=Below Limit of Quantification
Exploratory – Non-inflammatory
Lesions
Non-inflammatory (NIN) lesion counts were studied
only as an exploratory endpoint as they were not part of the label
claim of our reference listed drug. In the BPX-01 2% arm, NIN
lesion counts (-12.0 vs. -9.9, p=0.7882) and percentage changes
(34.1% vs. 30.7%, p=0.8946) were observed. In the BPX-01 1% arm,
NIN lesions counts (-8 vs. -9.9, p=0.4753) and percentage changes
(24.3% vs. 30.7%, p=0.6180) were observed.
Topline Results Previously Reported
The topline
results for the phase 2b OPAL study of BPX-01 1% and 2% reported
that both concentrations statistically significantly reduced
inflammatory lesions, the study's primary endpoint. Since topline
reporting, adjustments for multiple comparisons were made,
resulting in a change to the p-value for the 1% concentration,
rendering the results for the 1% concentration no longer
statistically significant.
Study Design
The phase 2b study was a randomized,
double-blind, three-arm, vehicle-controlled dose-finding study to
assess the efficacy and safety of BPX-01 for the treatment of
moderate-to-severe acne vulgaris. The multi-center study
evaluated two concentrations of BPX-01 (1% and 2% minocycline) and
vehicle and enrolled 226 subjects, aged 9 to 40, with 20-60
moderate-to-severe inflammatory, non-nodular acne lesions.
About Acne
The American Academy of Dermatology calls
acne the "most common skin condition in the United States,"
affecting up to 50 million Americans. The U.S. market for
prescription acne medications is estimated at $4 billion.
About BioPharmX® Corporation
BioPharmX Corporation
(NYSE MKT: BPMX) is a Silicon Valley-based specialty pharmaceutical
company that seeks to provide products through proprietary platform
technologies for prescription, over-the-counter and supplement
applications in the health and wellness markets, including
dermatology and women's health. To learn more about BioPharmX,
visit www.BioPharmX.com.
Forward-Looking Statement
The information in this
press release contains forward-looking statements and information
within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, which are subject to the "safe harbor" created by those
sections. This press release contains forward-looking statements
about the company's expectations, plans, intentions and strategies,
including, but not limited to, statements regarding, the safety and
medical effects of BPX-01, the effect BPX-01 may have on the
treatment of acne, the timing of presenting trial results,
commencement and results of future trials involving BPX-01 and the
size of such trials, continued and consistent results in future
tests of BPX-01 and absence of side effects of future use of
BPX-01. These forward-looking statements may be identified by words
such as "plan", "expect," "anticipate," "believe," or similar
expressions that are intended to identify such forward-looking
statements. These forward-looking statements involve risks and
uncertainties, as well as assumptions, which, if they do not fully
materialize or prove incorrect, could cause our results to differ
materially from those expressed or implied by such forward-looking
statements. The risks and uncertainties include those described in
the company's filings with the Securities and Exchange Commission.
Given these risks and uncertainties, you are cautioned not to place
undue reliance on such forward-looking statements. The
forward-looking statements included in this news release are made
only as of the date hereof and the company undertakes no obligation
to publicly update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise,
except as may be required under applicable securities laws.
BioPharmX is a registered trademark of BioPharmX, Inc.
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SOURCE BioPharmX Corporation