SAN FRANCISCO, April 28, 2021 /PRNewswire/ -- Kindred
Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company
focused on saving and improving the lives of pets, today
announced that the United States Department of Agriculture (USDA)
Center for Veterinary Biologics has accepted efficacy data to
support the prophylactic indication for KIND-030. The pivotal
efficacy data demonstrated that 0% of the KIND-030 treated dogs
developed parvovirus infection while 100% of the placebo-control
dogs developed the disease, and also showed 100% survival rate in
KIND-030. The efficacy study is part of the overall project data
package required for full approval, along with safety,
manufacturing and additional data. KIND-030 is a monoclonal
antibody targeting canine parvovirus (CPV), and is partnered with
Elanco Animal Health (NYSE: ELAN).
CPV is the most significant and contagious viral cause of
enteritis in dogs, especially puppies, with mortality rates
reportedly as high as 91% if untreated. There are currently no Food
and Drug Administration or USDA approved treatments for CPV, nor
any other available treatment. Currently, owners spend up to
thousands of dollars per puppy in supportive care for CPV, with
average cost of $1,200.
"As the first acceptance of efficacy data in one of our biologic
programs, this marks a key milestone for KindredBio and brings us a
step closer to transforming the care of dogs affected by this
devastating disease. It has taken less than four years from concept
to first efficacy study acceptance, underscoring the speed and
efficiency of our drug development model," said KindredBio's Chief
Executive Officer, Richard Chin,
M.D.
As detailed in a September 2020
press release, in this randomized, blinded, placebo-controlled
study, KIND-030 was administered to dogs as prophylactic therapy to
prevent clinical signs of CPV infection. The primary objectives of
the study were met. The data were submitted to the USDA on
February 25, 2021.
"We are pleased with the progress of KIND-030 and our
collaboration with the KindredBio team to advance this product
through the final steps of the development and approval process"
said Jeff Simmons, President and CEO
of Elanco Animal Health, "We look forward to bringing this novel
antibody to veterinarians to address the challenges of parvovirus
infections in dogs."
KIND-030 is currently being pursued for two indications in dogs:
prophylactic therapy to prevent clinical signs of canine parvovirus
infection and treatment of established parvovirus infection. The
pivotal efficacy study for the treatment indication is expected to
be completed in the second quarter of 2021, with potential approval
of both indications by year-end. Regulatory approval and review
timeline are subject to the typical risks inherent in such a
process.
KIND-030 binds to critical portions of the virus, preventing the
virus from entering into cells.
Veterinarians estimate that about half of the puppies they see
infected with parvovirus have potentially exposed other puppies to
the virus, and each puppy has on average the potential to expose
five other puppies to the disease1.
About Kindred Biosciences
Kindred Biosciences is a biopharmaceutical company
developing innovative biologics 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 targets that have already
demonstrated safety and efficacy in humans and to develop
therapeutics based on these validated targets for dogs and cats.
KindredBio has a deep pipeline of novel biologics in development
across many therapeutic classes, alongside state-of-the-art
biologics manufacturing capabilities and a broad intellectual
property portfolio.
For more information, visit: www.kindredbio.com
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 products and our product candidates
for the foreseeable future; the likelihood that our revenue will
vary from quarter to quarter; our potential inability to obtain any
necessary additional financing; our substantial dependence on the
success of our products and 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 related to our products and our
product candidates and the potential inability of these
manufacturers to deliver a sufficient amount of supplies on a
timely basis; the uncertain effect of the COVID-19 pandemic on our
business, results of operations and financial condition;
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 enter into satisfactory agreements with third-party
licensees of our biologic products and uncertainty about the amount
of revenue that we will receive from such agreements; our
significant costs of operating as a public company; potential
cyber-attacks on our information technology systems or on our
third-party providers' information technology systems, which could
disrupt our operations; our potential inability to repay the
secured indebtedness that we have incurred from third-party
lenders, and the restrictions on our business activities that are
contained in our loan agreement with these lenders; the risk that
our 2020 strategic realignment and restructuring plans will result
in unanticipated costs or revenue shortfalls; uncertainty about the
amount of royalties that we will receive from the sale of Mirataz®
to Dechra Pharmaceuticals PLC; the risk that the revenue from our
delivery of services or products under any contract may be less
than we anticipate if the other party to the contract exercises its
right to terminate the contract prior to the completion of the
contract or if such party is unable or unwilling to satisfy its
payment obligations under the contract; our potential inability to
obtain and maintain patent protection and other intellectual
property protection for our products and 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.
The canine parvovirus monoclonal antibody is not yet licensed by
the United States Department of Agriculture Center for Veterinary
Biologics.
Contacts
For investor inquiries:
Katja Buhrer
Katja.buhrer@kindredbio.com
(917) 969-3438
1 Data on file at Kindred
Biosciences, Inc. 2019 Veterinarian Parvovirus Research:
Anti-Canine Parvovirus Monoclonal Antibody
Assessment 10.9.2019
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SOURCE Kindred Biosciences, Inc.