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USDA approves the claim that the product is effective for the passive immunization of healthy dogs 13 weeks of age or older against canine parvovirus (CPV) disease
Results demonstrated 100% efficacy against the deadly disease, highlighting the potential to address a critical unmet medical need
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
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The canine parvovirus monoclonal antibody is not yet licensed by the United States Department of Agriculture Center for Veterinary Biologics.
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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.