MENLO PARK, Calif.,
Oct. 11, 2018 /PRNewswire/
-- BioPharmX Corporation (NYSE American: BPMX), a specialty
pharmaceutical company developing products for the dermatology
market, today announced that it has enrolled the first subject in a
Phase 2b clinical trial of BPX-04, a
novel topical gel formulation of minocycline for the treatment of
rosacea.
The trial is a randomized, double-blind, vehicle-controlled
study in subjects with inflammatory lesions of rosacea. The
12-week, multi-center study will evaluate BPX-04, a 1% topical
minocycline, carried by the HyantX™ delivery system, a proprietary,
anhydrous hydrophilic topical system developed by BioPharmX.
The trial plans to enroll 176 subjects at least 18 years old with
an investigator's global assessment (IGA) score of 3 or 4 (moderate
or severe), and 15 to 70 inflammatory lesions on their faces at
baseline. The study allows for an optional interim analysis to
adjust the study's sample size.
"Dermatologists and their patients are still searching for
effective innovations in treatments for rosacea," said Neal Bhatia, M.D., director of clinical
dermatology at Therapeutics Clinical Research in San Diego who was the principal investigator
for the company's Proof-of-Concept (POC) trial. "The goal is to
substantiate early research conclusions that suggest BPX-04 may
offer the effective treatment of rosacea while minimizing the
unwanted adverse effects associated with oral forms of
antibiotics."
The primary endpoint for the study is an absolute mean change in
the number of inflammatory lesions of rosacea from baseline to week
12. The secondary endpoint is the proportion of subjects with at
least a two-grade reduction in IGA to clear (0) or almost clear
(1), from baseline to week 12.
"The enrollment of our first subject represents an important
milestone for BPX-04," said David
Tierney, BioPharmX CEO. "We are optimistic the study will
demonstrate that BPX-04 is safe, effective and easy to use, which
should significantly improve patient compliance – a serious
challenge to rosacea treatment."
Oral minocycline has been widely used in the treatment of skin
conditions like rosacea and acne since the 1970s, but the
pharmaceutical industry has not previously been able to develop a
stable, topical formulation of fully solubilized minocycline, which
appears to induce less resistance than other tetracycline-class
antibiotics commonly used for these diseases. By applying
minocycline topically, a patient will likely reduce the systemic
exposure of minocycline and focus the drug's beneficial effects at
the skin where they are needed most.
Termination of Anja
Krammer
In addition, BioPharmX announced that
Anja Krammer has been terminated as
BioPharmX's President. Following Ms. Krammer's termination,
David S. Tierney, M.D., BioPharmX's
CEO, has assumed the role of President. Michael Hubbard, Chairman of the BioPharmX
Board, said: "We are confident that Dr. Tierney will provide strong
leadership moving forward as our Chief Executive Officer and
President."
About HyantX™
The HyantX™ delivery system is a novel,
patented drug delivery platform that stabilizes and solubilizes
hydrophilic molecules in an anhydrous gel environment. It is
capable of carrying a variety of active ingredients – and even
combinations of actives - into the skin. Research has shown that
the delivery system may allow for maximum solubility for multiple
actives, which is intended to enhance skin penetration and increase
efficacy and tolerability, has antibacterial properties, and
hydrates the skin, making the delivery system a valuable asset in
pipeline development and strategic partnering.
About BioPharmX Corporation
BioPharmX Corporation (NYSE American: BPMX) is a specialty
pharmaceutical company, developing prescription products through
proprietary platform technologies 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, BioPharmX's executive leadership, the commencement
and results of future trials of BPX-04 and the size of such trials,
the safety and medical effects of BPX-04 and the HyantX™ delivery
system, the effect BPX-04 may have on the treatment of rosacea, the
absence of side effects of future use of BPX-04 and BioPharmX's
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