SAN FRANCISCO, June 2, 2021 /PRNewswire/ -- Kindred
Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company
focused on saving and improving the lives of pets, today
announced positive results from a pivotal efficacy study of
KIND-030 in dogs infected by parvovirus. The primary endpoint was
survival and the results showed 100% survival in the treated group
versus 43% survival in the placebo group.
KIND-030, a monoclonal antibody targeting canine parvovirus
(CPV), is partnered with Elanco Animal Health (NYSE: ELAN).
In this randomized, blinded, placebo-controlled study, KIND-030
was administered to dogs after they tested positive for CPV
infection. The primary endpoint of the study was met. The
parvovirus challenge resulted in 57% mortality rate in the control
dogs compared to 0% mortality rate in the KIND-030 treated dogs.
The dogs did not receive any supportive care or other
treatments.
"Parvovirus is a devastating disease currently without any
available treatment," said KindredBio's Chief Executive Officer,
Richard Chin, M.D. "With 100%
efficacy, we believe KIND-030 has the potential to revolutionize
the care of these dogs. Instead of a lengthy and expensive
hospitalization that is frequently ineffective and can leave the
dog with permanent disabilities, the infected dogs can now be
treated with a single injection without need for additional
supportive care or hospitalization."
"We are excited to partner with KindredBio on this revolutionary
treatment that can significantly improve the health and well-being
of dogs," said Jeff Simmons,
president and CEO of Elanco Animal Health. "With our significant
global reach and access to veterinarians and pet owners around the
world, Elanco looks forward to leveraging our capabilities and
skilled team of experts to advance and commercialize this novel
treatment for pets globally."
With this positive study, KIND-030 has now demonstrated efficacy
in both indications being pursued: prophylactic therapy to prevent
clinical signs of canine parvovirus infection, and treatment of
established parvovirus infection. Results from the pivotal efficacy
study for the therapeutic claim are expected to be submitted to the
United States Department of Agriculture (USDA) in June, with
possible approval by year-end 2021.
CPV is the most significant and contagious viral cause of
enteritis in dogs, especially puppies, with mortality rates 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. Veterinary intervention is limited to
supportive care, which can cost owners up to thousands of dollars
per puppy, with an average cost of $1,200.
Canine parvovirus is most often seen in puppies less than 6
months of age, but can occur in unvaccinated dogs of any age.
Clinical signs often include depression, not eating, vomiting, and
profuse diarrhea which is often blood tinged.1 Banfield
estimates that there are approximately 250,000 parvo cases in the
U.S. each year, excluding emergency hospitals, shelters, specialty
hospitals, or undiagnosed cases.2
KIND-030 binds to critical portions of the virus, preventing the
virus from entering into cells.
On April 28, 2021 KindredBio
announced acceptance of the parvovirus antibody prophylaxis
study data and approval of the efficacy indication by the USDA
Center for Veterinary Biologics. The pivotal efficacy data for the
prophylactic indication 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.
Regulatory approval and review timeline are subject to the
typical risks inherent in such a process. The results of the
pivotal efficacy study for the therapeutic claim stated in this
press release have not been reviewed by the USDA Center for
Veterinary Biologics.
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.
Contacts
For investor inquiries:
Katja Buhrer
Katja.buhrer@kindredbio.com
(917) 969-3438
1 American Kennel Club Canine Health Foundation.
Canine Parvovirus Information for Dog Owners. June 2018. Available from:
http://www.akcchf.org/canine-health/top-health-concerns/current-topics-in-infectious-disease/AKC-CHF-Canine-Parvovirus-Fact-Sheet.pdf
[Access Date: Sept. 14, 2020].
2 2014 Banfield
State of Pet Health report compiled from the
medical data of 2.3 million dogs treated at Banfield Pet Hospitals
2013.
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SOURCE Kindred Biosciences, Inc.