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SAN FRANCISCO, Aug. 20, 2014 /PRNewswire/ -- Kindred Biosciences, Inc. (KindredBio, NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, announced today that its pivotal field study (KB010) of CereKin, an interleukin-1 inhibitor for the control of pain and inflammation associated with osteoarthritis in dogs, 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. 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. Detailed results will be submitted for presentation at an upcoming scientific meeting.
"We would like to thank the team, investigators, and pet owners who helped make this study possible. While we are disappointed that this study did not meet its primary endpoint, this is just the first of more than a dozen programs," stated Richard Chin, M.D., President and Chief Executive Officer of KindredBio. "The total cost of the CereKin program has been approximately $4 million, which represents less than five percent of our cash resources. 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. The critical part of our business model is that we are taking a portfolio approach and the results from any single program have a limited impact."
KindredBio continues to advance its rich pipeline. It is continuing to enroll patients in the pivotal studies for AtoKin and SentiKin. A PK study of extended-release SentiKin for postoperative pain in cats has been completed. A PK study of a drug for the stimulation of appetite in cats has been initiated. A PK study of a drug for fever in horses is expected to start this quarter. Significant progress has been made in the biologics programs, including erythropoietin for cats with anemia and immune checkpoint inhibitors for dogs with cancer. All of these product candidates, if approved, would be first-in-class drugs in the pet therapeutic market.
KindredBio will host a conference call and webcast at 5:30 pm EDT today:
Interested parties may access the call by dialing toll-free (855) 433-0927 from the US, or (484) 756-4262 internationally, and using conference ID 91627369.
The call will also be webcast live at http://www.media-server.com/m/p/numx8rre. A replay will also be available at that link for 30 days.
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's lead product candidates are CereKin (diacerein) for the treatment of osteoarthritis pain and inflammation in dogs, AtoKin (fexofenadine) for the treatment of atopic dermatitis in dogs, and SentiKin (flupirtine) for the treatment of post-operative pain in dogs and cats.
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.
These forward-looking statements are based on our current expectations. These statements are not promises or guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results to be materially different from any future results expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: our limited operating history and expectations of losses for the foreseeable future; the absence of revenue from our product candidates for the foreseeable future; our potential inability to obtain any necessary additional financing; our substantial dependence on the success of our lead product candidates, which may not be successfully commercialized even if they are approved for marketing; the effect of competition; our potential inability to obtain regulatory approval for our existing or future product candidates; our dependence on third parties to conduct some of our development activities; our dependence upon third-party manufacturers for supplies of our product candidates; uncertainties regarding the outcomes of trials regarding our product candidates; our potential failure to attract and retain senior management and key scientific personnel; uncertainty about our ability to develop a satisfactory sales organization; our significant costs of operating as a public company; our potential inability to obtain patent protection and other intellectual property protection for our product candidates; potential claims by third parties alleging our infringement of their patents and other intellectual property rights; our potential failure to comply with regulatory requirements, which are subject to change on an ongoing basis; the potential volatility of our stock price; and the significant control over our business by our principal stockholders and management.
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 for the year ended December 31, 2013 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.