MENLO PARK, Calif.,
July 31, 2018 /PRNewswire/
-- BioPharmX Corporation (NYSE American: BPMX), a specialty
pharmaceutical company developing products for the dermatology
market, today announced it has received Institutional Review Board
approval for its phase 2 study of BPX-04 for the treatment of
papulopustular rosacea.
The company also announced that, based on data from its
open-label feasibility study which assessed tolerability in
subjects with papulopustular rosacea, it has selected the 1%
minocycline concentration for use in the PRISM phase 2 trial to
evaluate the safety and efficacy of BPX-04, continuing in its
patient-centric commitment to antibiotic stewardship by utilizing a
lower dose of antibiotics for patients.
The 12-week, open-label feasibility study assessed the
tolerability of BPX-04 topical minocycline gel in 30 subjects with
moderate-to-severe papulopustular rosacea. Once-daily
administration of either 1%, 2%, or vehicle was applied to the
face. All treatment arms were well tolerated and there were no
serious adverse events, further demonstrating the patient-centric
benefits of the BioPharmX HyantX™ delivery system underpinning
BPX-04.
"Optimizing delivery to the source of the disease, while
minimizing the risks of oral antibiotics in patients with rosacea,
has the potential to influence better prescribing options for
dermatologists," said Dr. Neal
Bhatia, a board-certified dermatologist at Therapeutics
Clinical Research in San Diego and
the study's principal investigator. "Dermatologists have long
desired a new topical antibiotic option that minimizes the risks of
systemic side effects while not contributing to the bigger issue of
systemic antibiotic resistance."
Dr. Bhatia highlighted BPX-04 data at the recent American
Academy of Dermatology Summer Meeting in a presentation called
"Therapeutic Update" in Chicago. Long-term safety and
efficacy, as well as treatment strategies with these new regimens
were also discussed.
The National Rosacea Society describes rosacea as a common, but
poorly understood disorder of the facial skin that affects an
estimated 16 million Americans, many of whom do not even know they
have the condition. Rosacea is characterized by facial redness,
pimples, bumpy breakouts, and thickening of the skin.
BPX-041 is the company's second candidate utilizing
the novel, patented HyantX™ delivery system, which is designed to
stabilize and solubilize hydrophilic molecules in an anhydrous gel
environment. This delivery system is being developed to carry a
variety of active ingredients – and even combinations of actives –
into the skin. Research has shown the delivery system may
allow for maximum solubility for multiple actives, which is
intended to lead to enhanced skin penetration and increased
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 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
This press release contains
forward-looking statements related to the company's plans or
developments that involve risks, uncertainties and assumptions, and
are subject to the "safe harbor" of the Private Securities
Litigation Reform Act of 1995. These statements may be identified
by words such as "plan," "expect," "believe," "intend," "should,"
"may" or similar expressions. Important factors that could cause
actual results to differ materially than those expressed or implied
in such statements include, but are not limited to, the
commencement and results of future trials of BPX-04 and the size of
such trials, 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.
1Caution: BPX-04 is a new drug limited by U.S. law to
investigational use.
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SOURCE BioPharmX Corporation