SAN JOSE, Calif., March 4, 2019 /PRNewswire/ -- BioPharmX
Corporation (NYSE American: BPMX), a specialty pharmaceutical
company focused on developing innovative medical dermatology
products, today announced that it has completed enrollment of its
Phase 2b clinical trial with
BPX-041, a novel topical gel formulation of fully
solubilized minocycline for the treatment of papulopustular
rosacea.
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"This is an important milestone for our rosacea program and we
look forward to reporting topline results from the study later this
year," said David Tierney, BioPharmX
CEO. "Unlike currently available therapies which may further
irritate a patient's already sensitive skin, BPX-04—which utilizes
our proprietary HyantX topical delivery system—was designed to
improve the bioavailability of solubilized minocycline and enable a
more targeted delivery to minimize irritation. Based on results
from earlier studies, we believe that BPX-04 may provide an
effective treatment for rosacea while minimizing the unwanted
adverse effects associated with oral forms of antibiotics, as well
as the tolerability limitations of topical treatments, thereby
addressing an unmet need for 16 million patients in the US
alone."
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.
The randomized, double-blind, vehicle-controlled study enrolled
207 subjects with moderate-to-severe papulopustular rosacea. The
multicenter study is evaluating 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's primary
endpoint is the mean change in the number of facial inflammatory
lesions of rosacea from baseline to week 12.
About BioPharmX Corporation
BioPharmX Corporation
(NYSE American: BPMX) is a specialty pharmaceutical company
developing prescription products through its proprietary HyantX™
Topical Delivery System for dermatology indications. To learn more
about BioPharmX, visit www.BioPharmX.com.
Forward-Looking Statements
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 the timing for the
announcement of topline results for the study, the safety and
medical effects of BPX-04, the effect BPX-04 may have on the
treatment of rosacea, absence of side effects of future use of
BPX-04 and ability to advance BPX-04 through a successful NDA
submission and commercialization. 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 most recent fiscal quarter. 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 such
statements.BioPharmX is a registered trademark of BioPharmX,
Inc.
1 Caution: BPX-04 is a new drug limited by U.S. law
to investigational use.
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SOURCE BioPharmX Corporation