Nexvet Biopharma (Nasdaq:NVET), a veterinary biologic therapy
developer, announced today an update on its pivotal field safety
and efficacy study for its lead product candidate (NV-01), a novel
monoclonal antibody (mAb) therapy for the control of pain
associated with osteoarthritis in dogs.
The study, which commenced in October 2014, was designed to
enroll at least 200 dogs with naturally occurring osteoarthritis.
The study, which is being conducted at veterinary clinics across
the United States and Europe, has enrolled 184 dogs as of March 7,
2015, which are randomized into treatment groups with a 2:1 ratio
of NV-01 to placebo study subjects.
As part of the study protocol, each dog receives three
treatments at 28-day intervals. The protocol requires that, when
133 dogs reached the 28-day primary endpoint, which represented 67%
of the study participants, a sample size reassessment would be
performed by an independent statistician. That assessment has
recently been completed.
The statistical sample size reassessment considered the
performance of the two treatment groups to evaluate whether the
study is adequately powered to predict a significant benefit of
NV-01 treatment over placebo. The sample size reassessment also
evaluated whether the study is likely to be futile based upon two
measurements: 1) that placebo is superior to NV-01 with regard to
treatment success, or 2) the requirement to increase the number of
NV-01 treated dogs to potentially over 1,000 participants.
The outcome of the sample size reassessment was as
follows:
1. In order to have a high probability of a statistically
significant endpoint at the day 28 primary assessment, it will be
necessary to increase the current size of the study.
2. Futility was not observed in the sample size
reassessment.
As soon as possible, the Company will be meeting with the
regulatory authorities to discuss the results of the sample size
reassessment. The Company is considering the optimal size for the
study but currently intends to continue recruiting dogs for the
study as planned. The Company is assessing the impact of time,
cost, and related logistical issues regarding the feasibility of
substantially increasing the number of dogs in the current study,
or initiating additional studies. At this time, the study remains
fully blinded, which means the results and data generated to this
point are not available for the Company's review. Nexvet plans to
complete the study without un-blinding it, which avoids
compromising the data such that it may be used in the future for
U.S. and European regulatory purposes.
"We've accumulated a strong pre-clinical data package for NV-01
and we remain committed to optimizing this promising therapy for
treatment of chronic pain associated with osteoarthritis,"
commented Mark Heffernan, Chief Executive Officer of Nexvet.
About the NV-01 Pivotal Field Safety Study
Design
Each dog receives three treatments at 28-day intervals. Efficacy
is measured using two different owner-administered assessment
tools, the Client-Specific Outcome Measures (CSOM) and Canine Brief
Pain Inventory (CBPI), together with veterinarian assessments of
pain and lameness. The study is double-blinded, meaning
participants and veterinarians are unaware of which treatment group
will be receiving NV-01 or a placebo. CSOM, CBPI and veterinarian
assessments are being measured at enrollment and on days 14, 28, 56
and 84. The CSOM measures activities that have become difficult or
have changed for the dog as a result of osteoarthritis. For the
CSOM assessment, precise activities that have changed in dogs as a
result of osteoarthritis are defined and re-evaluated at each
assessment. The relative ability to perform such activities is
assigned a numerical score at each observation. A comparison of the
change in CSOM score between enrollment and day 28 is the primary
endpoint for the efficacy evaluation. CSOM assessments on other
days, CBPI assessments and veterinarian pain and lameness
assessments are secondary endpoints.
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 create 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.
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 ability to reach a statistically
significant endpoint at the primary assessment of the NV-01 pivotal
field safety and efficacy study (whether or not we increase the
number of enrolled dogs), the feasibility of increasing the number
of enrolled dogs in our NV-01 pivotal field safety and efficacy
study, future expenditures relating to NV‑01, business strategy,
prospective products, 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 materially different
from any future results, performance or achievements expressed or
implied by the forward-looking statements. The words "anticipate,"
"continue," "could," "estimate," "expect," "intend," "may,"
"objective," "plan," "potential," "project," "position," "seek,"
"will," "would," or the negative of these terms or other similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. These forward-looking statements are based on
current expectations, estimates, forecasts and projections about
our business and the industry in which we operate, and management's
beliefs and assumptions are not guarantees of future performance or
development and involve known and unknown risks, uncertainties and
other factors.
Factors that could cause actual results to differ materially
from our expectations include those summarized under Risk Factors
in our registration statement on Form S-1 (SEC File 333-201309) and
the other documents we file from time to time with the Securities
and Exchange Commission. Given these risks and uncertainties, you
should not place undue reliance on these forward-looking
statements. Also, forward-looking statements represent management's
beliefs and assumptions only as of the date of this press release.
Except as required by law, we do not intend, and undertake no
obligation, to revise or update these forward-looking statements,
or to update the reasons actual results could differ materially
from those anticipated in these forward-looking statements, even if
new information becomes available in the future.
CONTACT: Further Information
Investors
Hershel Berry
Blueprint Life Science Group
+1 415-375-3340 Ext. 102
hberry@bplifescience.com
Company
Mark Heffernan
CEO, Nexvet Biopharma plc
+61 417 351 272
mark.heffernan@nexvet.com
Media
Lynn Granito
Berry & Company Public Relations
+1 212-253-8881
lgranito@berrypr.com
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