Aratana Therapeutics Provides Product Updates
Provides additional details on AT-001 pivotal efficacy study, announces two technical section complete letters for safety...
Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on the licensing, development and commercialization of innovative biopharmaceutical products for companion animals, today provided several product updates. The company continues to advance its deep pipeline of novel therapeutics, including four products at pivotal stage (AT-001, AT-002, AT-003 and AT-014) and two products in post-approval marketing studies (AT-004 and AT-005). Aratana remains on track to achieve additional significant inflection points for its programs in 2015, including results from pivotal field effectiveness studies of AT-002 and AT-003, each in dogs.
Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics, commented, «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 and meeting the critical commercial manufacturing objectives. We are particularly pleased that our model of developing innovative pet therapeutics is being validated by these achievements. We look forward to reporting on further clinical developments as the year progresses».
AT-001. In December 2014, Aratana announced positive top-line data from its pivotal field effectiveness study of AT-001 for osteoarthritis pain in dogs. Today, the company provided additional details:
- The blinded, placebo-controlled, multi-center study of AT-001 enrolled approximately 280 client-owned dogs with osteoarthritis. Dogs were randomized equally into one group treated with AT-001 and one group treated with placebo. Dogs were dosed for 28 days, and effectiveness was determined.
- Clinical success rates based on the validated Canine Brief Pain Inventory (CBPI) at day 28 were 48.1% for the once-daily dose of AT-001 vs. 31.3% 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 FDA’s Center for Veterinary Medicine (CVM).
- The two subsets of the CBPI, the Pain Severity Score and the Pain Interference Score both improved significantly on day 28. Furthermore, the clinical success rates on days 7, 14 and 21 vs. placebo group were all statistically significant.
Adverse reactions in the pivotal field effectiveness study were limited to mild adverse events and AT-001 was not associated with abnormalities in liver and renal parameters that are associated with NSAIDs from the class of cyclooxygenase inhibitors, or Coxibs. Aratana anticipates submitting the pivotal study results to the CVM to satisfy the effectiveness technical section in 2015. In January 2015, Aratana received the target animal safety technical section complete letter for AT-001 in dogs from the CVM.
Aratana anticipates the CMC technical section complete letter for AT-001 in 2016, after which it anticipates filing an Administrative New Animal Drug Application (NADA) in 2016. Aratana continues to anticipate approval of AT-001 in dogs in 2016.
AT-003. The company initiated its pivotal field effectiveness study in dogs for AT-003 in December 2014. The study will evaluate AT-003 for post-operative pain management in dogs undergoing knee surgery. In January 2015, Aratana received the target animal safety technical section complete letter for AT-003 in dogs from the CVM. The company continues to anticipate approval of AT-003 in dogs in 2016.
AT-004. The company announced on January 5, 2015 that it received a full license from the U.S. Department of Agriculture (USDA) for its monoclonal antibody to aid in the treatment of canine B-cell lymphoma. AT-004 is exclusively licensed to a third party for commercialization in the U.S. and Canada.
The licensee recently placed a quality hold on AT-004 when it determined that there was a potential quality issue in the manufacturing of one serial lot of AT-004. Aratana initiated and continues an investigation into the serial lot and has placed a stop sale on that lot, which was manufactured in 2013 and whose expiry extension was recently approved by the USDA.
AT-005. AT-005 has received a conditional license from the USDA in January 2014 as an aid in the treatment of canine T-cell lymphoma, and Aratana continues to anticipate receiving a full license in 2015. Aratana continues to evaluate its canine-specific monoclonal antibody targeting CD52 as an aid in the treatment of T-cell lymphoma in dogs:
Aratana has successfully completed enrollment of its T-CHOMP study — a multicenter, blinded, placebo-controlled, randomized study designed to assess the benefit of adding AT-005 to a multi-agent chemotherapy protocol for dogs with intermediate to high grade T-cell lymphoma. There are 48 client-owned dogs enrolled in this study. All enrolled dogs are receiving the current chemotherapy standard of care (CHOP protocol) which is supplemented by either placebo or the monoclonal antibody. Dogs are randomized equally (1:1) to receive antibody or placebo during the chemotherapy protocol and the veterinary oncologist performing the dogs’ evaluations is blinded to their group assignment. The study is expected to be completed by third quarter 2016.
Aratana continues to enroll patients in its T-LAB study – a multicenter, blinded, placebo-controlled, randomized study designed to assess the benefit of adding AT-005 to an abbreviated chemotherapy protocol for dogs with intermediate to high grade T-cell lymphoma. The study is expected to fully-enroll in 2015 and results are expected in 2016. Aratana continues to expand AT-005 availability in its T-cell Clinical Experience Program or T-CEP. Aratana is currently receiving product orders from approximately two dozen oncology practices.
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.