SAN FRANCISCO, Dec. 4, 2017 /PRNewswire/ -- 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.
This press release contains forward-looking statements within the meaning of the U.S. 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, but not limited to, statements regarding our expectations about the trials, regulatory approval, manufacturing, distribution and commercialization of our current and future product candidates, and statements regarding our anticipated revenues, expenses, margins, profits and use of cash.
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For a further description of these risks and other risks that we face, please see the risk factors described in our filings with the U.S. Securities and Exchange Commission (the SEC), including the risk factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K and any subsequent updates that may be contained in our Quarterly Reports on Form 10-Q filed with the SEC. As a result of the risks described above and in our filings with the SEC, actual results may differ materially from those indicated by the forward-looking statements made in this press release. Forward-looking statements contained in this press release speak only as of the date of this press release and we undertake no obligation to update or revise these statements, except as may be required by law.
SOURCE Kindred Biosciences, Inc.