Aratana Therapeutics Announces Positive Top-Line Results from AT-001 Pivotal Field Study in Client-Owned Dogs with Osteoarthritis
KANSAS CITY, Kan., Dec. 18, 2014 /PRNewswire/ -- Aratana Therapeutics, Inc. (NASDAQ: PETX), a biopharmaceutical company focused on the licensing, development and commercialization of innovative medications for companion animals, today announced positive results from its pivotal field study of AT-001 (Grapiprant), the company’s innovative drug for treating pain in dogs with osteoarthritis. In the study, dogs receiving AT-001 demonstrated improvements in pain assessment scores that were statistically significant compared to placebo (p<0.05) at a once-daily oral dose. Aratana expects to commence commercialization upon FDA approval, which Aratana anticipates in 2016.
The blinded, placebo-controlled, multi-center study of AT-001 enrolled 280 client-owned dogs with osteoarthritis. Dogs were randomized equally into one group treated with AT-001 and one group treated with placebo. Dogs were dosed for 28 days, and effectiveness was determined by a standard protocol utilizing a validated owner-assessed pain score.
Ernst Heinen, DVM, Ph.D., Head of Drug Evaluation and Development for Aratana Therapeutics, stated, "We are very pleased with these results, which gives us confidence in moving forward towards approval of this novel drug.”
Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics, added, “We believe AT-001 has the potential to be an important product in the well-established pain market. We look forward to continuing our dialogue with the FDA’s Center for Veterinary Medicine regarding the AT-001 program.”
Aratana will discuss these results in more detail when the final study reports are available.
About Aratana Therapeutics
Aratana Therapeutics is a pet therapeutics company focused on licensing, developing and commercializing innovative biopharmaceutical products for companion animals. Aratana believes that it can leverage the investment in the human biopharmaceutical industry to bring therapeutics to pets in a capital and time efficient manner. The company's pipeline includes therapeutic candidates targeting pain, inappetence, cancer, viral diseases, allergy and other serious medical conditions. Aratana believes the development and commercialization of these therapeutics will permit veterinarians and pet owners to manage pets' medical needs safely and effectively, resulting in longer and improved quality of life for pets. For more information, please visit www.aratana.com.
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SOURCE Aratana Therapeutics, Inc.