Aratana Therapeutics Reports Positive Pilot Field Study of AT-002 in Cats

Aratana Therapeutics, Inc.

, a pet therapeutics company focused on the licensing, development and commercialization of innovative biopharmaceutical products for companion animals, today announced the positive results of a pilot field study of AT-002 (capromorelin) in cats. Capromorelin is a small molecule that mimics ghrelin, the naturally occurring hormone that stimulates appetite, increases body weight and increases serum growth hormone levels. The multi-site, placebo-controlled, pilot field study of approximately 40 cats measured weight gain/loss in cats with chronic kidney disease and documented weight loss who received AT-002 at a dose of 2 mg/kg compared to cats that received placebo treatment. Both groups were treated orally once daily for 90±3 days. AT-002 treated cats had statistically significant increases in body weight compared to placebo after 90 days (p<0.01) with differences beginning on day 30. AT-002 was well tolerated. Aratana recently met with the FDA's Center for Veterinary Medicine (CVM) to discuss the results, and the company intends to initiate a pivotal field effectiveness study in mid-2016. Assuming success in the pivotal field effectiveness study in cats and completion of other technical sections, Aratana anticipates FDA approval of AT-002 in cats in 2018. In June 2015, Aratana announced positive top-line data from its pivotal field effectiveness study of AT-002 for inappetence in dogs. Today, the company provided additional details: The double-masked, randomized, placebo-controlled, multi-site, pivotal field study enrolled more than 200 client-owned dogs with reduced appetite (inappetence) from a variety of causes. Dogs were randomized equally into one group treated with AT-002 at 3 mg/kg once daily and one group treated with placebo once daily for 4 ±1 days. Dogs were assessed for effectiveness on day 4 with an owner appetite assessment instrument. Secondary endpoints included an alternative owner appetite assessment questionnaire and body weight. Clinical success rates were approximately 70% for the once-daily dose of AT-002 group vs. approximately 45% for the placebo group, which represents a statistically significant difference (p<0.05), thereby achieving the study's primary endpoint as agreed under protocol concurrence with the CVM. The clinical success rates using the alternative owner appetite assessment were statistically significant (p<0.05) in favor of the AT-002 treatment group. Body weight assessed as a positive change from baseline was also statistically significant (p<0.05) in favor of the AT-002 treatment. Aratana will discuss the results with the CVM before final p-values can be calculated and agreed upon. AT-002 appeared to be palatable and well accepted. Aratana also reported the results of a separate placebo-controlled laboratory study in 24 beagle dogs who received AT-002 once daily at 3 mg/kg or placebo once daily for 4 days. Dogs who received AT-002 demonstrated an increased percent change in food consumption from Day 0 to Day 3 that was statistically significant compared to placebo (p<0.001) with AT-002 treated dogs demonstrating increases in mean food consumption of 61% versus placebo-treated of -11%. Percent change in body weight Day 0 to Day 3 was statistically significant compared to placebo (p<0.001) with AT-002 treated dogs demonstrating weight gain of 6% versus placebo-treated dogs whose weight was unchanged. Aratana anticipates submitting the pivotal field effectiveness study results in dogs to the CVM as the final piece of the Effectiveness Technical Section. In March 2015, Aratana received the target animal safety technical section complete letter for AT-002 in dogs from the CVM. Aratana anticipates the CMC technical section complete letter for AT-002 by early 2016. Aratana anticipates filing an Administrative New Animal Drug Application (NADA) and continues to anticipate approval of AT-002 in dogs in mid-2016. Aratana continues its interactions with the European Medicines Agency and believes that its discussions and efforts will lead to the successful development of capromorelin outside the U.S. "We are very pleased with the results," stated Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics. "We believe that our success in both dogs and cats in acute and chronic settings will allow us to create a global product franchise in this important therapeutic category."