Nexvet Announces Initiation of Pivotal Efficacy Study of Frunevetmab in Cats
12 Décembre 2016 - 11:30AM
Nexvet Biopharma (Nasdaq:NVET) today announced it has initiated a
pivotal field efficacy and safety study of frunevetmab, the
Company’s anti-nerve growth factor (NGF) monoclonal antibody (mAb)
therapy which is being developed as a monthly subcutaneous
injectable for the control of pain associated with osteoarthritis
in cats. Nexvet expects to report data from both this study and a
currently running pivotal target animal safety study of frunevetmab
in the fourth quarter of calendar 2017.
The pivotal field efficacy and safety study will be a
placebo-controlled, randomized, double-blinded study with a target
enrolment of 250 cats with osteoarthritis at approximately 20
clinical sites around the United States. Enrolled cats will be
randomly assigned to receive frunevetmab or placebo at a 2:1 ratio.
Each cat will receive three doses, with each dose given 28 days
apart. This study has received protocol concurrence from the Center
for Veterinary Medicine at the United States Food and Drug
Administration and will utilize owner-assessed responses to
treatment as its primary endpoint.
“Frunevetmab’s successful proof-of-concept and pilot studies, as
well as market research, strongly support our investment in this
pivotal study. We are excited to be advancing a potential
first-in-class product in chronic cat pain, as it is a major
indication under-served by current therapeutic options. In the
United States, for example, there are currently no pain medications
approved for use in cats for longer than three consecutive days,
despite studies indicating that a majority of cats show signs of
degenerative joint disease, including osteoarthritis,” commented
Dr. Mark Heffernan, Chief Executive Officer of Nexvet.
“We therefore see a significant opportunity in opening up
chronic cat pain to a new class of therapeutic. We believe a
historic parallel can be seen when non-steroidal anti-inflammatory
drugs (NSAIDs) were introduced to the market in the late 1990s to
manage chronic canine pain. This began a dramatic expansion of the
U.S. market for companion animal pain management products,
predominantly for dogs, from under $10 million to approximately
$280 million today,” concluded Dr. Heffernan.
In May 2016, Nexvet announced the successful completion of a
randomized, placebo-controlled pilot field study of frunevetmab
which enrolled 126 cats with naturally occurring osteoarthritis.
This study demonstrated statistically significant improvements over
placebo at multiple endpoints and informed the endpoint design of
the pivotal field efficacy and safety study. No significant adverse
safety signals were observed in the study.
About Nexvet (www.nexvet.com)
Nexvet is a clinical-stage biopharmaceutical company 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 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 conducts
biomanufacturing in Ireland.
Forward looking statements
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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 (the “Exchange Act”). Forward looking statements
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facilities upgrades, ability to develop our pipeline of product
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or ability to qualify for conditional licensure
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Further information:
Investors
Candice Knoll
Blueprint Life Science Group
+1 415-375-3340 Ext. 4
cknoll@bplifescience.com
Media
Jessica Burns
Berry & Company Public Relations
+1 212-253-8881
jburns@berrypr.com
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