KANSAS CITY, Kan.
Dec. 23, 2013
Aratana Therapeutics, Inc.
(Nasdaq: PETX), a biopharmaceutical company focused on the licensing, development and commercialization of innovative medications for pets, today provided a year-end update on its development programs. The company continues to advance each of its small molecule drug candidates within the timelines previously guided and has achieved all planned year-end 2013 clinical milestones. Aratana remains on track to reach significant inflection points for these programs in 2014 and beyond.
Steven St. Peter
, M.D., President and Chief Executive Officer of Aratana Therapeutics, commented, "We have had an exciting year marked by successful corporate and clinical execution. As we continue to expand and enhance our pipeline of high-value pet therapeutics, we also remain sharply focused on advancing our clinical programs toward timely approvals. We are proud to maintain our strong clinical track record by achieving our 2013 milestones, and we look forward to reporting on expected clinical developments for the coming year, which include significant progress in both our dog and cat therapeutic programs."
In November, Aratana announced positive top-line data from its pivotal dose-ranging study of AT-001 for dogs, and selected a once-daily dose for further study. Today, the company provided greater detail on the results of that study:
- Clinical success rates at day 28 were 61.6% for the selected once-daily dose of AT-001 vs. 42.2% for the placebo group, when compared in a two-group parallel design, which represents a statistically significant difference (p<0.05)
- Adverse reactions at the selected dose were comparable to the placebo
- Aratana plans to move AT-001 forward into the pivotal field effectiveness study in 2014, and then, if the results are favorable, into commercialization upon approval, which is anticipated to be in 2016
Aratana also announced today that it has initiated the pivotal field effectiveness study for AT-002 in dogs, the company's novel drug candidate for treating inappetence.
- The randomized, placebo-controlled, multi-center study is expected to enroll approximately 150 client–owned dogs beginning in January 2014
- Top-line results are anticipated in the first half of 2015, and the company continues to anticipate potential U.S. approval to be in 2016
In previous studies, laboratory cats and dogs treated with AT-002 exhibited increased food intake and weight gain, and statistically significant results were seen in a dog pilot study of AT-002.