An appetite stimulant for dogs showed positive results in a pivotal field effectiveness study, according to developer Aratana Therapeutics Inc.
The drug—code-named AT-002—is delivered orally by syringe. Its chief ingredient, capromorelin, mimics ghrelin, a hormone that stimulates appetite, increases body weight and increases serum growth hormone levels, Aratana reported this month.
The Kansas City, Kan., company, which is working on a number of other animal drugs, hopes that AT-002 could be given to inappetent dogs suffering from acute or chronic illness, undergoing chemotherapy, recovering from surgery or enduring the last stage of life.
“We believe it could be a first-in-class approved drug for treating inappetence in dogs,” said Ernst Heinen, DVM, Ph.D., Aratana’s chief development officer.
More than 200 client-owned inappetent dogs received either a 3 mg/kg daily dose of capromorelin for four days or a placebo. The randomized, multisite study used an owner questionnaire to assess the results.
The data and other information will be delivered to the U.S. Food and Drug Administration’s Center for Veterinary Medicine.
“Based on current timelines for the FDA approval process, Aratana anticipates commencing commercialization of capromorelin for treatment of inappetence in dogs in 2016,” the company reported.
AT-002 also is being investigated for use in inappetent cats.
Pursuing other projects, Aratana is:
- Anticipating that AT-014, a vaccine for canine osteosarcoma, could receive a conditional license from the U.S. Department of Agriculture in 2016.
- Awaiting results from a pivotal field effectiveness study of AT-003, a bupivacaine liposome injectable suspension for post-operative pain management in dogs undergoing knee surgery.
- Developing AT-016 (allogeneic stem cell therapy) for canine osteoarthritis pain and AT-018 for canine atopic dermatitis.
- Working with Traverse Biosciences Inc. of Stony Brook, N.Y., to evaluate TRB-N0224 for the treatment and control of periodontal disease in dogs and cats.
Aratana has begun limited distribution of AT-005, a T-cell lymphoma treatment for dogs. The company reported $40,000 in net sales of AT-005 to about 20 animal hospitals during the fourth quarter of 2014.