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.
For more information or to download the corporate presentation,
visit www.KindredBio.com/LearnMore. Stay connected with KindredBio
on Facebook at www.Facebook.com/KindredBio.
Forward-Looking Statements
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
significant 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 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.
Contact
Russell Radefeld
KindredBio
russell.radefeld@kindredbio.com
(650) 701-7904
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SOURCE Kindred Biosciences, Inc.