As any pet owner can attest, when a dog stops eating it can be a source of major concern. With its recently approved product for dogs, Entyce, Aratana Therapeutics ($PETX) hopes to create a new market--a pharmaceutical approach to coaxing canines back to their food bowls. Towards that end, the company is offering details about what happened during the pivotal clinical trial for Entyce (capromorelin), which is liquid solution that mimics ghrelin, a hormone which sparks the feeling of hunger.
On June 10, Aratana presented the data at the American College of Veterinary Internal Medicine (ACVIM) forum in Denver. During the trial, which involved 244 pet dogs, 68.6% of pets taking Entyce experienced improvements in appetite, their owners reported. By comparison, just 44.6% of dogs taking a placebo improved. And 56.2% of the dogs on Entyce exhibited improvements in appetite-related behaviors, such as anticipating mealtime, eating with enthusiasm and actively seeking out food even when it’s not readily available. Just 26.8% of dogs on the placebo showed similar behaviors.
The drug was tried in dogs with a variety of conditions that can lead to a loss of appetite, including heart disease and gastrointestinal disorders. Over the course of the four days during which the dogs received Entyce, 76% of them also gained weight, according to Aratana, vs. just 45% of the placebo dogs. The most frequently reported adverse events involved stomach upset. A manuscript describing the study results is undergoing peer review for future publication in a veterinary journal.
Aratana will be relying on the data from this trial to fuel the marketing effort for Entyce, which the company is taking on singlehandedly. Aratana does have a co-promotion deal with Eli Lilly’s ($LLY) Elanco for another recently approved drug, Galliprant (grapiprant) for osteoarthritis pain in dogs, but CEO Steven St. Peter has told investors he’s confident his company can handle the Entyce rollout without a partner. That’s because the initial plan is to market the product to a small group of veterinary specialists.
If the rest of its regulatory submissions proceed as expected for Aratana, it could be out marketing another new drug for dogs later this year. Earlier this month, the company announced it completed the final technical section of its FDA submission for Nocita (bupivacaine), a long-acting injection to relieve pain in dogs who have undergone ligament surgery.
- access the Entyce data presentation here