San Francisco, CA (December 4, 2017) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced positive topline results from its pivotal field effectiveness study of Zimeta™ (dipyrone oral gel) for the control of pyrexia (fever) in horses.
This study was a multicenter, randomized, blinded, placebo-controlled pivotal study that enrolled 139 horses to assess the effectiveness of Zimeta Oral. The primary endpoint was improvement or resolution of fever 6 hours after treatment. The success rate was approximately 78% in the Zimeta Oral group vs. approximately 18% in the placebo group (p = 0.0026). Based on preliminary review of the safety data, the drug appears to be well tolerated.
KindredBio has completed the in-life portion of the Target Animal Safety Study and is analyzing the data. The Company anticipates submitting the Effectiveness technical section of the New Animal Drug Application in early 2018, and the Safety and Chemistry, Manufacturing and Controls technical sections in the first half of 2018, assuming the data are supportive of approval.
Richard Chin, M.D., President and Chief Executive Officer, stated, “We are very pleased with the results of the pivotal study of Zimeta Oral for the control of pyrexia in horses. This is our third consecutive, positive pivotal study and demonstrates KindredBio’s ability to rapidly and successfully develop products. With the caveat that the safety and CMC data are still pending, we look forward to bringing this important medicine to patients. With Zimeta IV™ (dipyrone injection) under review with FDA, the potential to add Zimeta Oral to the treatment paradigm will allow us to realize the full market potential for controlling fever in horses.”
About Kindred Biosciences
Kindred Biosciences is a pre-commercialization stage biopharmaceutical company focused on saving and improving the lives of pets. Its mission is to bring to pets the same kinds of safe and effective medicines that human family members enjoy. The Company’s strategy is to identify compounds and targets that have already demonstrated safety and efficacy in humans and to develop therapeutics based on these validated compounds and targets for dogs, cats and horses. The Company has a deep pipeline of novel drugs and biologics in development across many therapeutic classes.
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