San Francisco, CA (March 15, 2016) Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced the submission to FDA of the Safety technical section of the New Animal Drug Application (NADA) for Zimeta™ (dipyrone injection, KIND-012). This is the final major technical section to be submitted for Zimeta. The Chemistry, Manufacturing, and Controls technical section was submitted in December 2015 and the Effectiveness technical section was submitted in February 2016.
In the target animal safety study, Zimeta, was well tolerated with no clinically-significant changes when compared to control horses (placebo group). There were no Zimeta‑related macroscopic or microscopic changes identified during evaluation of tissues for pathology (including the GI tract) at the proposed labeled dose of 30 mg/kg.
Richard Chin, CEO of KindredBio, stated, “We are pleased to bring Zimeta one step closer to approval. We believe that with its favorable safety profile in horses, Zimeta will offer an attractive first-in-class therapy for an important unmet medical need. The Zimeta program was completed ahead of time and on budget, further validating our development model. I want to congratulate the KindredBio team and our investigators for their dedication and hard work.”
About Kindred Biosciences
Kindred Biosciences is a development-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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