Nexvet Announces Positive Results From NV-01 Pivotal Study in Dogs With Osteoarthritis

Nexvet Biopharma

, a veterinary biologics developer, today announced positive results from its pivotal safety and efficacy study of NV-01, the Company's anti-nerve growth factor (NGF) monoclonal antibody (mAb) therapy in development for the control of pain associated with osteoarthritis in dogs. The study met its primary endpoint as agreed under protocol concurrence with the Center for Veterinary Medicine (CVM) at the U.S. Food and Drug Administration (FDA). The primary endpoint achieved was a statistically significant (p=0.038) improvement over placebo in the assessed level of pain as measured using changes in Client-Specific Outcome Measures (CSOM) score between enrolment and day 28. Additionally, NV-01 was found to be safe and well-tolerated with no significant adverse safety signals observed in the study. Clinically meaningful magnitudes of benefit and statistically significant differences over placebo were also achieved for the majority of the secondary endpoints measured in the study. These included pain assessments measured using the validated pain scoring protocols CSOM and CBPI (Canine Brief Pain Inventory) at various points in time. Collectively, the results of this study constitute a substantial body of efficacy data that Nexvet intends to use as the basis of its planned submissions for marketing authorizations in both the U.S. and Europe. A conference call will take place today at 9:00AM ET where management will discuss the results. Dial-in information is posted below. "This is a tremendous outcome for Nexvet and we are particularly pleased to receive strong data supporting the long duration of efficacy following a single monthly injection, a key advantage for monoclonal antibody therapies over small molecules. This achievement is a testament to the power and potential of our proprietary PETization platform, invented by our Chief Scientific Officer Dr. David Gearing, to produce effective 100% species-specific veterinary therapeutic candidates," commented Dr. Mark Heffernan, Chief Executive Officer of Nexvet. This pivotal, multi-center, placebo-controlled, randomized, double blind study was conducted at 12 sites (6 in the U.S. and 6 in Europe). Protocol concurrence was received from the FDA CVM in August 2014. The final number of evaluable dogs in the study was 246, with 80 receiving placebo and 166 receiving NV-01. Dogs participating in the study received a subcutaneous injection of NV-01 once per month for three months. Nexvet plans to publish the final study report in a peer-reviewed journal in due course. The Company plans to discuss further details regarding the NV-01 pivotal study and its other programs at its Animal Health Symposium, taking place in New York City on November 23, 2015. Parties interested in attending should email ir@nexvet.com.