MENLO PARK, Calif.,
Nov. 8, 2017 /PRNewswire/
-- BioPharmX Corporation (NYSE MKT: BPMX), a specialty
pharmaceutical company developing products for the dermatology
market, today announces it has received positive feedback from the
U.S. Food and Drug Administration (FDA) regarding design of its
planned phase 3 clinical trial for BPX-011, the
company's topical minocycline gel for the treatment of inflammatory
lesions of acne vulgaris.
The company has incorporated feedback from the FDA on key
elements of its phase 3 acne program and received clear guidance
regarding expectations and requirements for clinical, non-clinical,
and chemistry, manufacturing and controls (CMC) needed to support a
post phase 3 NDA submission.
Consistent with oral minocycline products, BPX-01 is intended
for the targeted treatment of non-nodular inflammatory acne
vulgaris. Therefore, BioPharmX believes that an Investigator's
Global Assessment (IGA) scale specific to inflammatory lesions is
the most appropriate IGA scale to measure treatment success in the
co-primary efficacy endpoint as described in the 2005 guidance
document for acne product development. The FDA concurred with the
company's proposal to use an inflammatory lesion IGA as a
co-primary endpoint along with inflammatory lesion reduction.
Topical drug makers typically have not used IGA scales specific
to inflammatory or non-inflammatory lesions in their
studies. BioPharmX believes that it would be the first company
to model its IGA scale for a topical acne product similar to those
used by orally administered counterparts. The company further
believes use of this modified scale may yield a higher probability
for a positive outcome on this critical endpoint.
In what BioPharmX believes to further differentiate its phase 3
acne program from other topical acne programs, the company plans to
pursue an intended label indication of treatment of inflammatory
lesions of acne vulgaris. An indication specific to inflammatory
lesions is consistent with the indication for oral minocycline for
acne; and, BPX-01, as a topical product, will result in lower
systemic exposure to the antibiotic.
In light of this positive feedback from the FDA, the company
continues to consider various options as it finalizes its study
design plans and works on additional program requirements needed
for an NDA submission. The company is considering strategic
partnering alternatives to fund its phase 3 acne clinical trials
and expects to begin the trial, should the company raise the
necessary capital or upon entering into a strategic partnership to
fund the trials.
"We are extremely pleased to reach agreement with the FDA on our
proposed endpoints and believe that this could allow the company to
move towards a strategic partnership that will fund our phase 3
program and advance our novel topical gel acne product towards
commercialization," said Anja
Krammer, president of BioPharmX. "We further believe
that agreement on these endpoints could help us better achieve
positive clinical trial results, and enter the market with a
compelling product for the treatment of inflammatory acne."
About BPX-01
BPX-011 is a hydrophilic (non-oil-based) topical gel
with fully solubilized minocycline that has been shown to penetrate
the skin to deliver the antibiotic to its target. Following
positive results from its previously announced phase 2b dose range
study of BPX-01 in acne, BioPharmX continues with phase 3 clinical
study plans for BPX-01 for the treatment of inflammatory lesions of
acne.
About BioPharmX Corporation
BioPharmX Corporation (NYSE MKT: 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, 2017 and our quarterly report on Form 10-Q for
the period ended July 31, 2017. 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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SOURCE BioPharmX Corporation