FDA issues the equivalent of a Special Protocol Assessment on KIND-001 and KIND-002 Pivotal Studies.
SAN FRANCISCO, California. (July 2, 2013) – Kindred Biosciences, Inc. (KindredBio) announced today that it has received concurrences from the Center for Veterinary Medicine of the U.S. Food and Drug Administration (FDA) on its protocols for two pivotal (Phase III) field studies for KIND-001 and KIND-002. A protocol concurrence, similar to a Special Protocol Assessment for a human study, is a written commitment from the FDA that it is in agreement with the design, execution, and the analysis proposed in the protocol.
Richard Chin, CEO of KindredBio, stated, “We are delighted to receive concurrence from the FDA on our first two pivotal studies. The concurrences are major advances toward our goal to bringing the benefits of KIND-001 and KIND-002 to our patients.”
“Best Medicines for Our Best Friends”
KindredBio is a leading veterinary biotechnology company, focused on developing breakthrough therapies for dogs, cats, and horses. Founded by industry veterans formerly from Genentech and Elan Pharmaceuticals who have experience developing antibody drugs such as Lucentis®, Tysabri®, Xolair®, and Rituxan®, Kindred Bio is committed to bringing the very best science and medicine to companion animals.
KIND-001 is a cytokine inhibitor being developed for inflammatory conditions in dogs.
KIND-002 is molecule being developed for a dermatological disease in dogs.
Forward-looking statements in this news release involve inherent risks and uncertainties and a number of important factors could cause actual results to differ materially from those contained in such forward-looking statements. These factors include, but are not limited to uncertainties associated with: drug development and regulatory review process, scientific discovery process, competition, pricing environment, financing, intellectual property, and evolution of the companion animal market. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date.
Lucentis® is a registered trademarks of Genentech, Inc. Rituxan® is a registered trademark of Biogen Idec Inc. Xolair® is a registered trademark of Novartis AG Corporation. Tysabri® is a trademark of Elan Pharmaceuticals, Inc.