Posted: 2016-05-26 in Press Releases
Nexvet Announces Positive Results from NV-02 Pilot Field Study in Cats with Osteoarthritis
NV-02 Pivotal Study Plans Underway
Efficacy outcomes were primarily measured using cat owner assessments of changes in their cat’s pain and disability using two recognized pain assessment tools, Client-Specific Outcome Measures (CSOM) and the Feline Musculoskeletal Pain Index (FMPI). Owners were blinded to the treatment assignment of their pet. In this study, subcutaneous (SC) and intravenous (IV) administrations of NV-02 were evaluated against placebo and NV-02 was found to be highly effective by both routes of administration. Comparison of the combined NV-02 treatment groups with placebo showed the following top-line results:
- A statistically significant improvement on the assessed level of pain as measured using changes in CSOM score between enrollment and both day 42 (P<0.05) and day 56 (P<0.01)
- A statistically significant difference between NV-02-treated cats and placebo for the CSOM Global Assessment on both day 28 (P<0.05) and day 56 (P<0.01). The Global Assessment measures overall owner experience with the treatment course.
- A statistically significant improvement over placebo in the assessed level of pain measured using the FMPI at day 42 (P<0.01) and day 56 (P<0.05)
- NV-02 was found to be safe and well-tolerated with no significant adverse safety signals observed
This multi-center, placebo-controlled, randomized, double-blind field study was conducted at 15 sites in
"Chronic feline pain is an area of major unmet medical need, with no pain medications approved for chronic use in cats in
The NV-02 pilot study data will be presented at a Nexvet-hosted seminar at the
About NV-02 and the cat chronic pain market
NV-02 is a fully felinized or ‘100% cat’ anti-NGF mAb produced using Nexvet’s proprietary PETization platform technology for the rapid design of mAbs recognized as ‘self’ or ‘native’ by an animal’s immune system.
NGF is a protein involved in nerve signalling, including pain signals. Anti-NGF mAbs seek to interrupt those signals to reduce pain. This approach to pain management has been validated in late-stage human trials, and has now been validated in veterinary species by Nexvet in multiple studies. Nexvet’s canine anti-NGF mAb, ranevetmab, completed a pivotal safety and efficacy trial in
NV-02 is being developed as a monthly subcutaneous injectable for cats: its target product profile makes it a potential first-mover in chronic feline pain, as there are no pain-relieving drugs approved for use for longer than three days in cats in
Nexvet believes the introduction of a safer and effective pain management product class for cats, such as anti-NGF mAbs, will result in significant sales growth, a dynamic observed when NSAIDs were first introduced to the canine pain market in the mid-1990s. In
In one leading veterinary industry report on pain management by
Oral dosing of cats is significantly harder than oral dosing of dogs, making convenience of administration and reduced dosing frequency particularly compelling product attributes in the treatment of chronic feline conditions. These attributes, as well as safety and efficacy, were included in a hypothetical target product profile by Nexvet put to 390 surveyed veterinarians in
According to the 2015-2016
Various clinical studies have indicated that a majority of cats show radiographic evidence of degenerative joint disease (DJD). DJD is a term encompassing various conditions, most notably osteoarthritis. Osteoarthritis is associated with progressive disability and pain, and its incidence increases with age and obesity. In a 2012 report compiled by leading U.S. veterinary hospital chain Banfield which included data on nearly 430,000 cats, the average lifespan of pet cats had increased 10% in the prior decade, and in the prior five years the prevalence of excess body weight had increased 90% and the prevalence of arthritis had increased 67%.
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
Forward looking statements
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