MENLO PARK, Calif.,
Jan. 4, 2017 /PRNewswire/
-- BioPharmX Corporation (NYSE MKT: BPMX), a specialty
pharmaceutical company developing products for the dermatology
market, today announced the on-time completion of enrollment in the
OPAL (tOPicAL Minocycline Gel) study – a Phase 2b dose finding
clinical trial to assess the efficacy and safety of BPX-01 for the
treatment of acne vulgaris.
The 12-week, multi-center, randomized, double-blind, three-arm,
vehicle-controlled OPAL study involves 225 individuals, aged 9 to
40, who have moderate-to-severe inflammatory, non-nodular acne
vulgaris.
"We are pleased there is so much interest in BPX-01 and are
optimistic the OPAL trial outcome will take BPX-01 one step closer
to providing those who suffer from acne with an advanced treatment
option," said AnnaMarie Daniels,
executive vice president of clinical and regulatory affairs at
BioPharmX. "Many in the dermatology community look forward to the
results, which we expect will be available in the first half of
2017."
The study's primary endpoint is absolute mean change from
baseline in inflammatory lesion counts at week 12. The secondary
endpoint is the proportion of subjects with at least a two-grade
reduction in Investigator's Global Assessment at week 12. Results
of the study will be used to guide Phase 3 trial design.
BPX-01 is the first fully solubilized, non-oily, easy-to-use
topical minocycline gel capable of being delivered to the
sebum-rich areas where P. acnes reside. The novel topical
formulation delivers drug directly to the source of acne while
avoiding systemic exposure to antibiotic. BPX-01 Phase 2a study
data showed the unique topical gel formulation of minocycline
reduced acne-causing bacteria by more than 90 percent after four
weeks – effectiveness comparable to much higher doses of oral
minocycline.
The American Academy of Dermatology calls acne the "most common
skin condition in the United States," affecting 40 million to 50
million Americans at any given moment. 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 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 whether topical
minocycline is effective in fighting inflammation caused by acne
vulgaris, and the results and timing of the Phase 2b OPAL trial.
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.
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SOURCE BioPharmX Corporation