Veterinary biologic therapy developer Nexvet Biopharma has announced the start 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 multi-centre, placebo-controlled, randomised, double-blind study received protocol concurrence from the Centre 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.
David Gearing, chief scientific officer of Nexvet said: “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 Colin Giles, vice president of clinical and regulatory affairs at Nexvet. “We believe veterinary mAbs offer exciting therapeutic potential in a range of conditions.”