DUBLIN, Ireland, Oct. 19, 2015 (GLOBE NEWSWIRE) -- Nexvet Biopharma (Nasdaq:NVET), a veterinary biologics developer, today announced the initiation of a pilot field study for its product candidate NV-02, an anti-nerve growth factor (NGF) monoclonal antibody (mAb) for the control of pain associated with osteoarthritis in cats. The initiation of this field study represents the next development milestone for NV-02, following positive results from a proof-of-concept efficacy study and a pilot safety study, both announced in June 2015.
"We are excited for the NV-02 program to advance into field studies. To our knowledge, this is the most advanced clinical study of a feline mAb therapy. We anticipate the data generated will be valuable in selecting the optimum dosing regimen for NV-02 and designing a future pivotal study," said Dr. Mark Heffernan, Chief Executive Officer of Nexvet.
The study will be a placebo-controlled, blinded, pilot field safety and efficacy study targeting enrolment of 90 cats with naturally occurring osteoarthritis. The study will take place across 15 sites in the United States, with each site equally distributing participants across a placebo group and NV-02 dosage groups. The cats will be assessed using a variety of methods for evaluating pain and mobility. The key outcomes for determining success will be a comparison between NV-02 dosage groups and a placebo group, over a period of 2 months. Nexvet expects data from the study will be available in the second quarter of 2016.
Currently, non-steroidal anti-inflammatory drugs (NSAIDs) are the leading class of analgesics in dogs and cats. In the United States, NSAIDs are not approved for chronic use in cats due to concerns over toxic side effects, which include gastrointestinal effects and damage to the kidneys and liver. mAbs such as NV-02 have a different mode of action to NSAIDs and may provide an effective and safe alternative for cats. Furthermore, Nexvet's mAbs are designed to be administered at intervals of several weeks, as compared to small molecule treatments such as NSAIDs, which can require daily or more frequent administrations.
In June 2015, Nexvet announced positive top-line results from its proof-of-concept efficacy study of NV‑02 in 32 cats with degenerative joint disease. This placebo-controlled study demonstrated statistically significant improvements by two measures. The full results of this study are being prepared for submission to a peer-reviewed journal for publication.
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 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, through conducting drug discovery in Australia, clinical development in the United States and Europe and biomanufacturing in Ireland.
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