Aratana Announces Positive Results from AT-002 Pivotal Field Effectiveness Study
Aratana announces positive results from its pivotal field effectiveness study of capromorelin (AT-002), the company’s innovative therapeutic for appetite stimulation in dogs. Capromorelin is a small molecule that mimics ghrelin, the naturally occurring hormone that stimulates appetite, increases body weight and increases serum growth hormone levels.
In the pivotal field effectiveness study, dogs receiving a 3 mg/kg daily oral dose of capromorelin for four days demonstrated statistically significant increases in appetite compared to placebo (p<0.05). The study was a randomized, masked, placebo controlled multi-site study that enrolled over 200 inappetent dogs. Appetite was assessed with an owner questionnaire comparing appetite at baseline to appetite after four days of treatment.
Ernst Heinen, DVM, Ph.D., Chief Development Officer for Aratana Therapeutics, stated, “The results from the pivotal field study demonstrate that capromorelin clearly stimulated appetite in client-owned dogs. We believe it could be a first-in-class approved drug for treating inappetence in dogs.”
The positive data from the pivotal field effectiveness study adds to the robust safety and efficacy data that has been generated in prior studies of capromorelin in dogs.
The pivotal field effectiveness study data are the final piece of the Effectiveness Technical Section that Aratana plans to submit to the Food and Drug Administration’s Center for Veterinary Medicine as the Company pursues marketing approval for capromorelin. Based on current timelines for the FDA approval process, Aratana anticipates commencing commercialization of capromorelin for treatment of inappetence in dogs in 2016.