MENLO PARK, Calif.,
Aug. 22, 2016 /PRNewswire/ --
BioPharmX Corporation (NYSE MKT: BPMX), a specialty pharmaceutical
company developing products for the dermatology market, today
released final findings from its Phase 2a safety study of BPX-01
that show the unique topical gel formulation of minocycline reduced
facial P. acnes by more than 90 percent after four weeks – a
statistically significant advantage over the study's control
vehicle.
Daily application of BPX-01 resulted in a statistically
significant reduction of P. acnes at four weeks compared to
baseline. The reduction at four weeks was also statistically
significant between BPX-01 and the vehicle control. No adverse
cutaneous effects were observed, no clinically significant
hematologic or chemistry alterations occurred, and no minocycline
was detected in the plasma at any timepoint.
The reduction of P. acnes was 91 percent after four weeks
of using BPX-01, a significant improvement for a topical
formulation.
The reduction in P. acnes achieved in the Phase 2a study
is similar to that reported in a 1996 study that effectively
defined oral minocycline as the superior antimicrobial to fight
P. acnes1
One recognized issue with oral minocycline is that – even though
it is the antibiotic most commonly prescribed for the treatment of
P. acnes – it enters the patient's bloodstream and can cause
unwanted side effects. The BPX-01 Phase 2a study found no
detectable levels of minocycline in the bloodstream of patients
using the topical minocycline. The study also found no
cutaneous toxicity and no adverse effects.
The reduction in P. acnes found during the Phase 2a study
in the per protocol population is shown in the following table:
P. acnes
Reduction with BPX-01 vs. Vehicle
|
|
BPX-01 1% Minocycline
Topical Gel (n=17)
|
Vehicle Control
(n=7)
|
Time Point
|
Mean % change from
baseline (SD)
|
Log10 mean
change from baseline (SD)
|
Mean % change from
baseline
|
Log10 mean
change from baseline (SD)
|
Week 4
|
-90.9%
|
-1.04*
(0.55)
|
-65.3%
|
-0.46**
(0.40)
|
*active at baseline
vs. active at week 4, p<0.0001
|
**active at week 4
vs. vehicle at week 4, p=0.020
|
"This analysis of our final results suggests that BPX-01 can be
effective in the reduction of P. acnes – but at a much
lower, safer dose than is common with oral minocycline, the
standard of care," said Anja
Krammer, president and co-founder of BioPharmX. "We are
excited to begin our Phase 2b study and optimistic it will confirm
the effectiveness of this product."
BPX-01 is the first topical gel formulation of minocycline that
can penetrate the skin to deliver the antibiotic to the site of
acne development in the pilosebaceous unit. BPX-01 is the first and
only stable hydrophilic (non-oil-based) topical gel with fully
solubilized minocycline.
The BPX-01 Phase 2a study randomized subjects to once daily
treatment with BPX-01 1% minocycline topical gel or a vehicle
control. The study's patient exit survey indicated 100 percent
satisfaction with BPX-01's usability and tolerability.
"The dermatology community is excited about the promise of
BPX-01," said Dr. Hilary Baldwin, a
board-certified dermatologist with nearly 25 of years of experience
and co-chair of the BioPharmX Therapeutic Dermatology Medical
Advisory Board. "We would love to have an effective topical
treatment that fights P. acnes without exposing patients to
the risk of systemic antibiotics."
The American Academy of Dermatology calls acne the "most common
skin condition in the United States," affecting 40 to 50 million
Americans. The U.S. market for acne medications is estimated at
$10 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 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,
efficacy and projected development of BPX-01. These forward-looking
statements may be identified by words such as "will," "can,"
"plan," "expect," "anticipate," "believe," or the negative of these
terms, and similar expressions that are intended to identify
forward-looking statements. These forward-looking statements
involve both known and unknown 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, including
but not limited to the sufficiency of our resources and our ability
to raise additional capital to continue our development programs,
our ability to successfully develop and commercialize potential
products such as BPX-01, as well as other risks and uncertainties
associated with the process of discovering, developing and
commercializing drug candidates that are safe and effective for use
as human therapeutics . Such risks and uncertainties include those
described in the company's filings with the Securities and Exchange
Commission, including our Annual Report on Form 10-K for the year
ended January 31, 2016 and our
Quarterly Reports on Form 10-Q. Given these risks and
uncertainties, you are cautioned not to place undue reliance on
such forward-looking statements. All information included in this
press release or cited herein is provided only as of the date
hereof and the company undertakes no obligation to publicly update
or revise any such statement, 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.
1 The antimicrobial effects in vivo of minocycline,
doxycycline and tetracycline in humans. Leyden JJ, Kaidbey K &
Gans EH. Journal of Dermatological Treatment (1996) 7, 223-
225.
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