NovaBay Pharmaceuticals’ Auriclosene® Demonstrates Statistically Significant & Clinically Meaningful Results in Phase 2b S...
September 19 2016 - 6:50AM
Business Wire
Positive clinical results in stringently
designed Phase 2b study provide basis for pivotal clinical
trials
NovaBay® Pharmaceuticals, Inc. (NYSE MKT: NBY), a
biopharmaceutical company, announces that data from a Phase 2b
clinical study with Auriclosene Irrigating Solution (AIS)
demonstrated statistically significant and clinically meaningful
results in the prevention of urinary catheter blockage and
encrustation in subjects with chronic indwelling urinary catheters
who have repeat history of blockage. Auriclosene is NovaBay’s
proprietary, non-antibiotic, fast-acting, broad-spectrum
antimicrobial that has exhibited the potential for rapid
decolonization of a range of urologic pathogens. Auriclosene has
been designated as a new chemical entity and granted composition of
matter patent protection to 2028 by the U.S. Patent Office.
“Of the approximately 300,000 patients in the U.S. with
indwelling catheters, about 100,000 chronically suffer from
blockage and encrustation. We estimate the healthcare costs to
manage these patients in the billion dollar range,” said Mark M.
Sieczkarek, Chairman, President and CEO of NovaBay. “The results of
this clinical study shows the potential of AIS to prevent urinary
catheter blockage and encrustation in this patient population,
which could provide millions of dollars in cost savings for the
health care system and significantly improve the quality of life
for these patients.
“With a market size we estimate at more than $700 million, we
believe AIS represents a substantial commercial opportunity. We are
actively pursuing partnering, licensing or joint venture deal
structures to monetize this non-core program and advance it through
pivotal trials to commercialization. This strategy is aimed at
bringing additional capital into NovaBay while we focus on building
our core Avenova business,” he added.
Phase 2b Study Results
In the parallel design, two-arm Phase 2b study, 36 subjects with
chronic indwelling catheters, including those with spinal cord
injuries and other neurological conditions such as multiple
sclerosis, were treated twice weekly for four weeks with either AIS
or Vehicle Solution (citric-acid buffer). This study was designed
to provide a stringent test of the ability of AIS to prevent
urinary catheter and blockage because the Vehicle Solution itself
has activity in minimizing encrustation. Standard of care for
catheter irrigation is saline solution, which has no activity
against biofilm and crystalline encrustation.
At the end of the treatment period, catheter flow rate
measurements based on an ASTM FDA-recognized standard from both
study arms were compared with flow measurements from identical new
catheters in a blinded evaluation. The primary efficacy endpoint
comparing percent flow rate reduction of AIS-treated catheters to
vehicle-treated catheters was achieved with statistical
significance (p values < 0.05). The clinical efficacy endpoint
was also achieved with statistical significance, with no blockage
in subjects in the AIS arm versus clinical blockage in 28% of the
subjects treated with vehicle. There were no serious adverse events
reported in the study and auriclosene was generally well
tolerated.
On September 16, 2013, NovaBay reported positive results with
AIS in a Phase 2 study in the same patient population treated in
the Phase 2b study. Results of the Phase 2 study showed that
irrigation with AIS was effective in preventing catheter
encrustation and blockage compared with irrigation with saline
solution. Saline has no activity against biofilm and crystalline
encrustation. The Phase 2 study differed from the Phase 2b study in
its crossover design with efficacy assessed by laboratory
measurement of catheter blockage. Each subject served as his/her
own control having catheters treated alternatively with AIS and
saline solution following a washout period. For 14 per-protocol
subjects, comparison of percent encrustation of catheters treated
with AIS and saline showed a significant reduction in favor of AIS
(Wilcoxon signed-rank test p value < 0.001). No serious adverse
events were reported, and overall tolerability was considered
good.
About Urinary Catheter Blockage and Encrustation
Chronic indwelling urinary catheterization is necessary for
patients with spinal cord injuries, multiple sclerosis, strokes or
other neurogenic bladder conditions. In these patients catheters
repeatedly become coated with bacteria and bacterial biofilm, which
may produce localized crystal deposits and may build up and block
the catheter. Major medical problems can follow. The severe
consequences of urinary catheter blockage and encrustation are
often underappreciated. Catheter blockage can result not only in
urinary tract infections and socially embarrassing urine leakage
around the catheter, but also frequent use of emergency services
and, in those with high-level spinal cord injuries, potentially
life-threatening autonomic dysreflexia.
About Auriclosene (NVC-422)
Auriclosene is NovaBay’s lead Aganocide compound. These
compounds work by mimicking the body’s natural defense against
infection. NovaBay has taken the effective and rapidly acting
molecules that function within our own bodies and created stable
analogs of these molecules. The Company’s compounds have shown to
be fast-acting with broad spectrum activity, effective against
multi-drug resistant bacteria and biofilm, and with a good safety
profile.
About NovaBay Pharmaceuticals, Inc.: Going Beyond
Antibiotics
NovaBay Pharmaceuticals is a biopharmaceutical company focusing
on the commercialization of prescription Avenova® lid and lash
hygiene for the eye care market. Avenova is formulated with
Neutrox®, which is cleared by the U.S. Food and Drug Administration
(FDA) as a 510(k) medical device. Neutrox is NovaBay’s pure
hypochlorous acid. Data from a multicenter clinical study show that
Avenova reduced bacterial load, the underlying cause of
blepharitis, on ocular skin surface by more than 90%. Laboratory
tests show that hypochlorous acid has potent antimicrobial activity
in solution yet is non-toxic to mammalian cells and also
neutralizes bacterial toxins. Avenova is marketed to optometrists
and ophthalmologists throughout the U.S. by NovaBay’s direct
medical salesforce. It is accessible from more than 90% of retail
pharmacies in the U.S. through agreements with McKesson
Corporation, Cardinal Health and AmeriSource Bergen.
Forward-Looking Statements
This release contains forward-looking statements, which are
based upon management's current expectations, assumptions,
estimates, projections and beliefs. These statements include,
but are not limited to, statements regarding our ability to find a
partner to continue this program, the anticipated market for this
product given it is still under development, the future sales of
the potential product, and the Company’s expected future financial
results. Forward-looking statements in this release can be
identified by the words “estimate,” “believe,” and “approximately,”
or variations of these words. These statements involve known and
unknown risks, uncertainties and other factors that may cause
actual results or achievements to be materially different and
adverse from those expressed in or implied by the forward-looking
statements. Factors that might cause or contribute to such
differences include, but are not limited to, risks and
uncertainties relating to unexpected adverse side effects or
inadequate therapeutic efficacy of AIS and the Company's ability to
obtain additional financing as necessary to continue this program
beyond its current state. Other risks relating to NovaBay’s
business, including risks that could cause results to differ
materially from those projected in the forward-looking statements
in this press release, are detailed in NovaBay's latest Form 10-K
and Form 10-Q filings with the Securities and Exchange Commission,
especially under the heading "Risk Factors." The
forward-looking statements in this release speak only as of this
date, and NovaBay disclaims any intent or obligation to revise or
update publicly any forward-looking statement except as required by
law.
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version on businesswire.com: http://www.businesswire.com/news/home/20160919005421/en/
NovaBay Pharmaceuticals, Inc.From the CompanyThomas J. Paulson,
510-899-8809Chief Financial OfficerContact TomorInvestor Contact:LHAJody Cain,
310-691-7100Jcain@lhai.com
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