Nexvet Biopharma ($NVET), which has been struggling to gain traction on Wall Street since its February IPO, said in a statement Wednesday that it is reassessing the study program for its lead compound, NV-01, after an initial review indicated that the current trial has a "low probability" of hitting the endpoint necessary for U.S. approval.
The drug, a monoclonal antibody for controlling pain in dogs with osteoarthritis, is unlikely to show a significant change in symptoms within a month of dosing unless the size of the study is increased, the company says. After assessing the time and cost involved in expanding the study, which has enrolled 200 dogs, Nexvet has decided to complete it by December, as originally planned, and then launch a second study that will also finish by the end of the year.
|Nexvet CEO Mark Heffernan|
Nexvet estimates the cost of the second study, which will enroll 150 dogs, will be $1 million, according to the statement. The new study "will enable the evaluation of alternative doses and treatment regimens and allow us to evaluate alternative endpoints to optimize NV-01's clinical assessment," said CEO Mark Heffernan in the release. He added that Nexvet's distribution partner, Virbac, remains committed to the drug.
The Dublin-based drugmaker hasn't had it easy since pricing its IPO at $10--well below the expected range of $13 to $16. In late March, Nexvet announced that its net loss in the fourth quarter of last year doubled to $2.4 million. The stock traded as low as $7 before bouncing back to $8.85. The company's current cash store is $21.7 million, but clearly resources are tight: Nexvet said in its statement on NV-01 that it plans to defer costs associated with the program until it completes both studies of the drug.
Osteoarthritis is one of the hottest pursuits in animal health, though the road to approval has been rocky. Last year, Kindred Biosciences ($KIN) missed the primary endpoint for its canine osteoarthritis drug candidate, which it later abandoned. Nexvet has no intention of giving up, however. The company says it's even continuing a parallel development program for cats with osteoarthritis.
Heffernan is cheered by the fact that late-stage trials of a similar monoclonal antibody for use in people with arthritis are moving forward, he said in the statement. "We believe the biology supporting this approach is well-substantiated and our previous studies with NV-01 in dogs are strongly supportive," Heffernan said.
- here's the press release