MENLO PARK, Calif.,
July 19, 2018 /PRNewswire/ --
BioPharmX Corporation (NYSE American: BPMX), a specialty
pharmaceutical company developing products for the dermatology
market, today announced that the U.S. Food and Drug Administration
has waived its requirement for a dermal carcinogenicity study for
BPX-01, eliminating several years of non-clinical research normally
required for FDA review.
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BPX-01, a novel topical gel formulation of minocycline for the
treatment of inflammatory acne, received the waiver based on the
results of a 39-week dermal minipig toxicity study conducted by
BioPharmX and the extensive safety history of minocycline products
including the clinical safety data from the BPX-01 Phase 2 acne
studies. The 39-week minipig study with BPX-01 found no
pre-neoplastic or hyperplastic changes that might be indicative of
carcinogenic potential and the clinical studies were also negative
in terms of cutaneous toxicity. Based on these data, FDA agreed
that no new useful information was likely to be gained by
additional non-clinical animal studies.
"The FDA waiver is important because it shaves years off of our
non-clinical research, accelerating our regulatory schedule and
eliminating concerns about the added time and costs of our
non-clinical development," said AnnaMarie
Daniels, BioPharmX executive vice president of clinical and
regulatory affairs. "Our minipig study confirmed years of prior
research showing that our BPX-01 topical minocycline poses no new
carcinogenic threat to humans."
The company also released a post hoc analysis of phase
2b data assessing the impact of
BPX-01 on the treatment of acne vulgaris in women. It found that
female subjects outperformed the overall study population in the
Investigator Global Assessment (IGA) outcomes.
The Phase 2b clinical trial
(ITT=219) was a 12-week randomized, double-blind,
vehicle-controlled, dose-ranging study to assess the safety and
efficacy of BPX-01 minocycline topical gel in the treatment of
moderate to severe inflammatory acne vulgaris. Relative to the
total ITT population, a higher proportion of subjects in the female
subgroup (N=149) demonstrated a clinically relevant improvement in
acne severity. In female subjects with a baseline IGA score of 3 or
4 (moderate-to-severe), 29.2% achieved a two-grade reduction to
clear or almost clear while 25% of the total ITT population
achieved this reduction. In female subjects with a baseline IGA
score of 3 (moderate only), 31.8% of subjects achieved a two-grade
reduction to clear or almost clear.
"The results from the female subgroup analysis of BPX-01 in the
Phase 2b acne trial is very relevant,
and offers promise to a large patient population suffering from
acne," said Hilary Baldwin, Medical
Director of the Acne Treatment & Research Center
in Morristown, NJ, and co-chair of the BioPharmX Medical
Advisory Board. "There is a significant need for a product that
offers not only efficacy, but just as importantly, cosmetic
elegance for women whose treatment options must fit their
lifestyles and skin care regimens."
The analysis will be presented at the Dermatology Education
Foundation's DERM2018 conference in a poster entitled "Subset
Analysis of IGA in Female Demographic in BPX-01 Topical Minocycline
Gel Phase 2b Trial for the Treatment
of Inflammatory Acne Vulgaris," on July
20 in Las Vegas.
BPX-01 uses the novel, patented HyantX™ delivery system, which
stabilizes and solubilizes hydrophilic molecules in an anhydrous
gel environment. This delivery system is capable of carrying 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.
BioPharmX continues to be in ongoing discussions with a number
of potential strategic partners regarding interest in the company's
BPX-01 product candidate for the treatment of acne. The company
continues to assess several written indications of interest and is
evaluating the variety of financial and strategic benefits of the
various options. Management remains diligent and deliberate in its
thoughtful consideration of options as it works to maintain the
best interests of the company and its shareholders.
About BioPharmX Corporation
BioPharmX Corporation (NYSE American: BPMX) is a Silicon
Valley-based specialty pharmaceutical company, which seeks to
provide products through proprietary platform technologies for
prescription, over-the-counter (OTC), 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 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, statements regarding strategic partnering alternatives,
the safety and medical effects of BPX-01, the effect BPX-01 may
have on the treatment of acne, the commencement and results of
future trials of BPX-01 and the size of such trials, continued and
consistent results in future tests of BPX-01, absence of side
effects of future use of BPX-01 and ability to advance BPX-01
through a successful NDA submission and commercialization. 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,
including our annual report on Form 10-K for the period
ended Jan. 31, 2018 and our quarterly report on Form 10-Q for
the period ended April 30, 2018.
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
law.
1 Caution: BPX-01 is a new drug limited by U.S. law
to investigational use.
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