An Irish veterinary biologics developer has announced positive results from a safety and efficacy study of a monoclonal antibody for the control of pain associated with osteoarthritis in dogs.
Nexvet Biopharma has completed the study of NV-01, the company’s anti-nerve growth factor monoclonal antibody therapy.
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
- 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 authorisations in both the US and Europe.
Nexvet chief executive Mark Heffernan said: “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 to produce effective 100% species-specific veterinary therapeutic candidates.”