Kindred Biosciences Inc. has been dealt a setback with the discovery that the startup drug company’s vanguard product, CereKin, failed a pivotal field study.
The Burlingame, Calif., company had hoped to achieve U.S. Food and Drug Administration approval of CereKin (diacerein) for the control of osteoarthritic pain and inflammation in dogs sometime in 2015.
Kindred reported Wednesday that CereKin “did not meet its primary endpoint.”
The randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of two doses of CereKin (5 mg/kg and 20 mg/kg).
“The data are in the process of being fully analyzed but, based on the analyses so far, the results appear to be due primarily to a higher-than-expected placebo response rate and statistical variability,” Kindred stated. “Also, in the high-dose group, the response rate among completers was in line with results seen in human studies, but the dropout rate was higher than expected and statistical significance was not achieved for the primary endpoint.”
Kindred spent about $4 million on the development of CereKin—a sum in line with what the drug maker anticipates spending on each project. Still in the pivotal study stage are AtoKin (fexofenadine), which is designed for the treatment of atopic dermatitis in dogs, and SentiKin (flupirtine), a nonopioid, nonsteroidal anti-inflammatory analgesic formulated to fight postoperative pain in dogs.
Kindred’s president and CEO, Richard Chin, M.D., remained optimistic about the company’s future.
“While we are disappointed that this study did not meet its primary endpoint, this is just the first of more than a dozen programs,” Chin said. “With over $100 million in funds, we have ample capital for additional programs, and we believe that over the long run we will be successful.”
Among other potential Kindred veterinary medications are extended-release SentiKin for postoperative pain in cats and drugs formulated to stimulate a cat’s appetite and treat fever in horses.