DUBLIN, Ireland and MELBOURNE, Australia, Oct. 16, 2014 (GLOBE NEWSWIRE) -- Veterinary biologic therapy developer Nexvet Biopharma today announced the initiation of a pivotal field efficacy and safety study of its lead product candidate NV-01: an anti-nerve growth factor monoclonal antibody (mAb) for the control of pain associated with osteoarthritis in dogs. The study will be conducted at veterinary clinics throughout the U.S. and EU. A minimum of 200 dogs will be enrolled in the study with results expected at the end of 2015. The first dog has been dosed in the study.
The multi-center, placebo-controlled, randomized, double blind study received protocol concurrence from the Center for Veterinary Medicine (CVM) at the US Food and Drug Administration (FDA) in August 2014. Dogs selected for inclusion in the study will receive once-monthly treatment with NV-01. The primary endpoint will be the reduction in osteoarthritis pain compared to placebo, as indicated by Client Specific Outcome Measures (CSOM), a validated pain assessment tool used for the approval of other pain medications in dogs.
Dr. David Gearing, Chief Scientific Officer of Nexvet commented, "The Nexvet team has worked diligently to bring NV-01, a 100% species-specific mAb generated via our proprietary PETization™ platform, to this pivotal milestone. As the pet dog population is living longer, the incidence of osteoarthritis has increased by as much as 38% since 2007. We are excited about the opportunity to provide safer and long-acting treatment alternatives for canine pain."
"The Nexvet team is proud to be the first animal health company to initiate a late stage veterinary study of a mAb therapy for the control of canine pain associated with osteoarthritis," said Dr. Colin Giles, Vice President of Clinical and Regulatory Affairs at Nexvet. "We believe veterinary mAbs offer exciting therapeutic potential in a range of conditions."
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" by an animal's immune system, a property referred 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's first product candidate, NV-01, is an anti-nerve growth factor mAb for the control of pain associated with osteoarthritis in dogs. Nexvet's second product candidate, NV-02, is an anti-nerve growth factor mAb for the control of pain associated with degenerative joint disease in cats. Nexvet's third product candidate, NV-08, is a tumor necrosis factor receptor fusion protein for the treatment of chronic inflammatory diseases, including atopic dermatitis, in dogs.
Nexvet's team members have international track records in the development of veterinary medicines and human biologics, and are committed to developing biologics to drive innovation in the global animal health therapeutic market, and give companion animals longer, healthier lives.
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Source:Nexvet Biopharma Pty Ltd