|Nexvet CEO Mark Heffernan|
As animal health innovations continue to extend the lives of our pets, our four-legged friends are facing some of the complications of aging that affect us--not the least of which is osteoarthritis. Dublin-based Nexvet Biopharma has become the first company to launch a pivotal clinical trial of a monoclonal antibody (mAb) designed to combat pain in dogs with osteoarthritis.
The study will take place at more than 10 veterinary clinics in the U.S. and Europe, and will enroll at least 200 dogs. The first dog was dosed last week. Nexvet expects to receive the data by the end of 2015, which would support a regulatory filing the following year, CEO Mark Heffernan tells FierceAnimalHealth.
The drug, called NV-01, is an anti-nerve growth factor mAb that was generated via Nexvet's PETization platform, which the company uses to rapidly create species-specific antibodies. Nexvet has gained quite a following in the venture capital world--it raised $31.5 million in an oversubscribed Series B financing in April--and this is the first drug from the PETization platform to reach a pivotal trial. "This is a major milestone for us," Heffernan says.
Heffernan explains that in an early proof-of-concept trial, NV-01 seemed to offer benefits over the current standard of care for dogs with osteoarthritis, which is daily doses of oral non-steroidal anti-inflammatories (NSAIDs). Those drugs are known to cause gastrointestinal side effects in dogs such as bleeding and ulceration, as well as liver and kidney toxicities. "We know that antibodies don't work through the same clearance mechanisms as small molecule drugs like NSAIDs, so we should overcome the adverse events," Heffernan says. "We haven't seen any gastrointestinal side effects in repeat dosing. Plus there's the added convenience of a once-monthly injection vs. a daily pill."
Still, the road to approval for new drugs in canine osteoarthritis has been anything but smooth. In August, Kindred Bioscience ($KIN) missed the primary endpoint for a trial of CereKin, its drug for canine osteoarthritis. That company's stock has tumbled from a 12-month high of $27 a share to a recent price of $9.
Nexvet remains undeterred, and is driven by an expanding market opportunity: The company estimates that the incidence of osteoarthritis in dogs has increased by 38% since 2007. Nexvet is also working on a mAb treatment for cats with osteoarthritis.
- here's the release