Nexvet Announces Successful Completion of NV-01 Pilot Field Study in Dogs With Osteoarthritis
10 March 2016 - 11:46AM
Nexvet Biopharma (Nasdaq:NVET), a veterinary biologics developer,
today announced the successful completion of its pilot field study
for ranevetmab* (NV-01), the Company's anti-nerve growth factor
(NGF) monoclonal antibody (mAb) therapy in development for the
control of pain associated with osteoarthritis in dogs.
This pilot field study was initiated in the second quarter of
2015 to evaluate a combination of doses and routes of
administration to complement the pivotal safety and efficacy study
for ranevetmab. In November 2015, Nexvet announced that the
completed pivotal study demonstrated ranevetmab’s safety and
efficacy (p≤ 0.038 for the primary endpoint) when administered by
subcutaneous (SC) injection once a month for three months. Results
from this most recent pilot study confirmed ranevetmab’s safety and
efficacy in a field study evaluating a range of dosages and
treatment regimens (SC and intravenous administration) in an
additional population of 176 dogs.
“Ranevetmab has been evaluated in 422 dogs with osteoarthritis
in the pivotal and pilot studies and has shown clinically
meaningful efficacy and an attractive safety profile. These results
reaffirm our belief that ranevetmab’s unique target product profile
will make it a first-in-class and best-in-class therapeutic for the
management of chronic pain associated with osteoarthritis in dogs,”
said Dr. Mark Heffernan, Nexvet’s Chief Executive Officer.
Nexvet is on track to submit the technical effectiveness section
of the NV-01 dossier to the FDA’s Center for Veterinary Medicine
(CVM) in the second calendar quarter of 2016, including the safety
data from this most recent study.
About Nexvet
(www.nexvet.com)
Nexvet is a veterinary biologics developer focused on
transforming the therapeutic market for companion animals, such as
dogs and cats, by developing and commercializing novel,
species-specific biologics. Nexvet’s proprietary PETization™
platform is designed to rapidly design monoclonal antibodies (mAbs)
that are recognized as “self” or “native” by an animal’s immune
system, a property Nexvet refers to as “100% species-specificity.”
Nexvet’s product candidates also build upon the safety and efficacy
data from clinically tested human therapies, thereby reducing
clinical risk and development cost.
Nexvet is leveraging diverse global expertise and incentives to
build a vertically integrated biopharmaceutical company, which
conducts drug discovery in Australia, conducts clinical
development in the United States and Europe and is
growing its biomanufacturing capabilities in Ireland.
*The United States Adopted Name (USAN) Council has approved the
generic name “ranevetmab” for NV-01.
Forward-Looking Statements
This press release contains forward-looking
statements 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. Forward-looking statements consist of all
statements other than statements of historical fact, including
statements regarding our future results of operations and financial
position, results of any current or future pivotal safety and
efficacy study, future expenditures relating to our lead product
candidates, time for completion of any of our studies, ability to
develop our pipeline of product candidates, business strategy,
prospective products, ability to successfully manufacture our own
product candidates, ability to obtain product approvals, research
and development costs, timing and likelihood of success, plans and
objectives of management for future operations, and future results
of current and anticipated products. These statements relate to
future events or to our future financial performance and involve
known and unknown risks, uncertainties and other factors which may
cause our actual results, performance or achievements to be
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and involve known and unknown risks, uncertainties and other
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differ materially from our expectations expressed in this report
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Further information:
Investors
Candice Knoll
Blueprint Life Science Group
+1 415-375-3340 Ext. 4
cknoll@bplifescience.com
Media
David Salisbury
Berry & Company Public Relations
+1 212-253-8881
dsalisbury@berrypr.com
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