Aratana initiates pivotal field effectiveness study for AT-001
Published on May 12, 2014 at 8:33 AM
Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on the licensing, development and commercialization of innovative biopharmaceutical products for cats, dogs and other companion animals, today announced the initiation of the pivotal field effectiveness study for AT-001 (grapiprant), the company's innovative drug for treating pain in dogs with osteoarthritis.
The randomized, blinded, multicenter pivotal study will enroll approximately 300 client-owned dogs with osteoarthritis, and will be conducted under a study protocol for which Aratana received concurrence from the FDA's Center for Veterinary Medicine (CVM). Dogs participating in the study will be given a once-daily low dose of AT-001 that was determined to be safe at therapeutic levels during the previous dose-ranging study, or placebo. The primary endpoint will be a reduction in osteoarthritis pain compared to placebo, as indicated by the Canine Brief Pain Inventory (CBPI) scale, a well validated and widely used scoring system.
Ernst Heinen, D.V.M, Ph.D., Chief Development Officer of Aratana Therapeutics, stated, "Osteoarthritis is the most common inflammatory joint disease in pets. AT-001 represents a truly differentiated approach to treating pain in pets. We look forward to reporting the pivotal study data, and if the results are favorable, to beginning commercialization upon approval, which is anticipated to be in 2016."
Aratana Therapeutics, Inc.