Aratana Therapeutics Announces Positive Pilot Field Study of AT-002 in Cats
Provides additional details on AT-002 in dogs
KANSAS CITY, Kan., July 27, 2015 /PRNewswire/ -- Aratana Therapeutics, Inc. (NASDAQ: PETX), 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."
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.
Forward-Looking Statements Disclaimer
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements with respect to capromorelin, including without limitation next steps in its continued development, commercialization plans and our belief that capromorelin is an innovative compound; the Company's plans and opportunities, including without limitation offering innovative therapeutics; bringing therapeutics to pets in a capital and time efficient manner, and the Company's belief that its products and product candidates will result in improved outcomes for pets.
These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our history of operating losses and expectations of losses for the foreseeable future; failure to obtain sufficient capital to fund our operations; our substantial dependence on the success of certain of our product candidates; our dependence on novel technologies and compliance with complex regulatory requirements; our inability to obtain regulatory approval for our existing or future product candidates; the lack of commercial success of our current or future product candidates; our inability to realize all of the anticipated benefits of our acquisitions and difficulty integrating acquired businesses; the uncertainty of outcomes of the development of pet therapeutics, which is a lengthy and expensive process; effects of competition; our inability to identify, license, develop and commercialize additional product candidates; our failure to attract and keep senior management and key scientific personnel; our reliance on third-party manufacturers, suppliers, and partners; regulatory restrictions on the marketing of our product candidates; unanticipated difficulties or challenges in the relatively new field of biologics development and manufacturing; our small commercial organization; difficulties managing the growth of our organization; our significant costs of operating as a public company; risks related to the restatement of our financial statements for the year ended December 31, 2013 and the identification of a material weakness in our internal control over financial reporting; changes in distribution channels for pet therapeutics; consolidation of our customers; limitations on our ability to use our net operating carryforwards; impact of generic products; unanticipated safety or efficacy concerns; our limited patents and patent rights; our failure to comply with our intellectual property license obligations; our infringement of third party patents and challenges to our patents or rights; litigation resulting from the misuse of our confidential information; the uncertainty of the regulatory approval process; our failure to comply with regulatory requirements or obtain foreign regulatory approvals; our failure to report adverse medical events related to our products; legislative or regulatory changes; the volatility of our stock price; our status as an "emerging growth company," as defined in the JOBS Act; the potential for dilution if we sell shares of our common stock in future financings; the influence of significant stockholders over our business; and effects of anti-takeover provisions in our charter documents and under Delaware law. These and other important factors discussed under the caption "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 16, 2015, along with our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
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