SAN JOSE, Calif., June 25, 2019 /PRNewswire/ -- BioPharmX
Corporation (NYSE American: BPMX), a specialty pharmaceutical
company focused on developing innovative medical dermatology
products, today announced positive results from its Phase
2b clinical trial of
BPX-041, a novel topical gel formulation of fully
solubilized minocycline for the treatment of moderate-to-severe
papulopustular rosacea. BPX-04, a 1% minocycline gel, successfully
met both the primary and secondary endpoints of the trial in
demonstrating a statistically significant mean change in the number
of facial inflammatory lesions and a two-grade improvement to clear
or almost clear on the Investigator's Global Assessment (IGA) scale
from baseline to week 12.
"We are extremely pleased with the positive outcome on both the
primary and secondary efficacy measures as well as the confirmation
of the safety and cutaneous tolerability of our minocycline gel
formulation. We view these results as further affirmation of the
benefits of BioPharmX's proprietary HyantX delivery system," said
Dr. David S. Tierney, BioPharmX CEO.
"Based on the efficacy and safety profile, we believe BPX-04 has
the potential to be the best-in-class treatment for papulopustular
rosacea."
Dr. Mark Amster, a
board-certified dermatologist and investigator in the clinical
trial, commented on the data and his experience as an investigator,
"My patients were extremely pleased with their participation in
this clinical trial. While the topline results highlight the
impressive efficacy of BPX-04, the most compelling takeaway from my
experience was my patient's satisfaction with BioPharmX's elegant
gel formulation and the lack of irritation that is so commonly
experienced with many topical agents. I look forward to the
advancement of this promising topical therapy."
Trial Design & Results
The randomized, double-blind, vehicle-controlled Phase
2b trial enrolled 206 subjects aged
18 years and above with moderate-to-severe papulopustular rosacea
across 11 sites in the United
States. The study evaluated the safety and efficacy of once
daily application of BPX-04, a 1% minocycline gel, versus a vehicle
control over a 12-week treatment period.
The study was designed to demonstrate a statistically
significant mean change in the number of facial inflammatory
lesions from baseline to week 12. The secondary endpoint, the
proportion of subjects with a two-grade improvement to clear or
almost clear on the IGA scale from baseline to week 12, was
included to collect sufficient data to design a Phase 3 program
with co-primary efficacy endpoints, however, as is standard in a
Phase 2 trial, the study was not designed to demonstrate
statistical significance on the secondary endpoint.
Baseline Severity
The mean inflammatory lesion count at baseline was 23.9 and 24.0
for the BPX-04 and vehicle treatment groups, respectively.
The proportion of subjects with an IGA score of 3 ("moderate")
and 4 ("severe") at baseline was 92.7% and 7.3% for the BPX-04
treatment group, respectively, and 91.1% and 8.9% for the vehicle
treatment group, respectively.
Efficacy Assessments
The below table details the primary and secondary efficacy
results from the trial whereby BPX-04 demonstrated a statistically
significant improvement from baseline. In addition to meeting the
primary and secondary endpoints of the trial, BPX-04 demonstrated a
statistically significant reduction in the number of facial
inflammatory lesions at all time points (weeks 4, 8 and 12).
|
BPX-04
Gel
(N=96)
|
Vehicle
(N=101)
|
p-value
|
Primary
endpoint*:
Mean change in the
number of facial inflammatory lesions from baseline to week
12
|
-13.6
|
-10.3
|
0.0040
|
Secondary
endpoint**:
Proportion of
subjects with a two-grade improvement in IGA to 0 ("clear") or 1
("almost clear") from baseline to week 12
|
52.3%
|
32.3%
|
0.0180
|
*MMRM (mixed-effects
model for repeated measures), ITT, MI; **GLMM (generalized linear
mixed model), ITT, MI
|
|
Note: The ITT
population was prospectively defined as all study patients
randomized who received at least one dose of the study product and
with at least one evaluation of primary and secondary endpoint
measures post-baseline visit. There were 9 subjects randomized that
did not meet the ITT criteria as there were no evaluation visits
post-baseline.
|
|
Safety and Tolerability
BPX-04 appeared to be generally well-tolerated. The most
commonly reported adverse events across both treatment groups were
upper respiratory tract infection (5.3%), gastroenteritis (2.4%)
and headache (2.4%) with the majority of these adverse events
determined to be not treatment-related. There were no serious
treatment-related adverse events.
About BPX-04
BPX-04 is a novel topical gel formulation
of fully solubilized minocycline for the treatment of
papulopustular rosacea. The product candidate leverages the HyantX™
topical delivery system, an anhydrous hydrophilic gel formulation,
designed for rapid absorption of active pharmaceutical ingredients
into the skin rather than remaining on the surface, a common
problem with oil‑based ointments and suspensions.
About Rosacea
Rosacea is a chronic dermatologic
condition characterized by redness, stinging and inflammatory
lesions primarily on the face. The biology of rosacea remains
unclear, however it is thought to be an inflammatory disorder that
involves immune responses and microorganisms. Rosacea is estimated
to affect more than 16 million people in the United States alone, according to the
National Rosacea Society. Current treatment options, while limited,
include oral antibiotics, anti-parasitics, azelaic acids and
alpha-A agonists.
About BioPharmX® Corporation
BioPharmX Corporation
(NYSE American: BPMX) is a specialty pharmaceutical company focused
on developing prescription products utilizing its proprietary
HyantX Topical Delivery System for dermatology indications. 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. These statements involve risks and uncertainties, which
could cause actual results to differ materially from our
predictions, and include, but are not limited to statements about
the safety and medical effects of BPX-04, the effect BPX-04 may
have on the treatment of rosacea, commencement and results of
future trials involving BPX-04 and the size of such trials,
continued and consistent results in future tests of BPX-04 and the
absence of side effects of future use of BPX-04. Additional risks
are set forth in our filings with the Securities and Exchange
Commission, including those described in the company's Quarterly
Report on Form 10-Q for the quarter ended April 30, 2019. The forward-looking statements
included in this press release are made only as of the date hereof,
and the company undertakes no obligation to publicly update such
statements.
1Caution: BPX-04 is a new drug limited by U.S. law to
investigational use.
BioPharmX and HyantX are registered trademarks of BioPharmX,
Inc.
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