Kindred Biosciences Announces Positive Results from Pivotal Study on the Efficacy of Parvovirus Monoclonal Antibody in Preventing Death in Parvovirus Infected Dogs | national news

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SAN FRANCISCO, June 2, 2021 / PRNewswire / – Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of companion animals, today announced the positive results of a pivotal study on the Efficacy of KIND-030 in Parvovirus Infected Dogs. 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 in partnership 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. Parvovirus challenge resulted in a 57% death rate in control dogs compared to a 0% death rate in dogs treated with KIND-030. The dogs received no supportive care or other treatment.

“Parvovirus is a devastating disease right now with no treatment available,” KindredBio CEO said, Richard chin, MD “With 100% effectiveness, we believe KIND-030 has the potential to revolutionize the care of these dogs. Instead of a long and expensive hospital stay which is often ineffective and can leave the dog with permanent disabilities, infected dogs can now be treated with a single injection without the need for additional supportive care or hospitalization.

“We are delighted to partner with KindredBio on this revolutionary treatment that can dramatically 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 animal owners around the world, Elanco looks forward to leveraging our capabilities and our team of qualified experts to advance and commercialize this new treatment for pets. company globally. “

With this positive study, KIND-030 has now demonstrated its effectiveness in the two indications pursued: prophylactic treatment to prevent clinical signs of infection by canine parvovirus and treatment of established parvovirus infection. The results of 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 the end of 2021.

CPV is the most important and contagious viral cause of enteritis in dogs, especially puppies, with death rates as high as 91% if left untreated. There is currently no Food and Drug Administration or USDA approved treatment for CPV, nor any other treatment available. 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 commonly seen in puppies under 6 months of age, but can occur in unvaccinated dogs of any age. Clinical signs often include depression, lack of food, vomiting, and profuse diarrhea often tinged with blood.1 Banfield estimates that there are approximately 250,000 cases of parvo in the United States each year, excluding emergency hospitals, shelters, specialty hospitals, or undiagnosed cases.2

KIND-030 binds to critical parts of the virus, preventing the virus from entering cells.

At April 28, 2021 KindredBio has announced the acceptance of data from the Parvovirus Antibody Prophylaxis study and approval of the efficacy indication by the USDA Center for Veterinary Biologics. Pivotal efficacy data for the prophylactic indication demonstrated that 0% of dogs treated with KIND-030 developed parvovirus infection while 100% of placebo control dogs developed disease, and also showed a 100% survival rate in KIND-030.

Regulatory approval and review schedule are subject to the typical risks inherent in such a process. The results of the pivotal efficacy study for the therapeutic claim shown in this press release have not been reviewed by the USDA Center for Veterinary Biologics.

About Kindred Biosciences

Kindred Biosciences is a biopharmaceutical company that develops innovative biologics focused on saving and improving the lives of pets. Its mission is to bring the same types of safe and effective medicines to pets as members of the human family. The Company’s strategy is to identify targets which have already demonstrated their safety and efficacy in humans and to develop therapies based on these targets validated for dogs and cats. KindredBio has an extensive pipeline of new biologics in development across many therapeutic classes, as well as advanced 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 United States Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to historical facts should be considered as forward-looking statements, including , but not limited to statements regarding our expectations regarding the testing, regulatory approval, manufacture, distribution and marketing of our current and future product candidates, and statements regarding our revenues, expenses, margins, profits and use of expected cash flow.

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 differ materially from future results expressed or implied by the statements. prospective. These risks include, but are not limited to, the following: our limited operating history and our expectation of losses for the foreseeable future; the lack of significant revenue from our products and product candidates for the foreseeable future; the likelihood that our revenues will vary from quarter to quarter; our potential inability to obtain any necessary additional financing; our substantial dependence on the success of our flagship products and product candidates which may not be successfully commercialized even if they are approved for commercialization; 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 on third party manufacturers for supplies related to our products and product candidates and the potential inability of such manufacturers to deliver a sufficient quantity 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 results of testing of our product candidates; our potential inability to attract and retain senior management and key scientific personnel; uncertainty as to our ability to enter into satisfactory agreements with third party licensees of our biologics and uncertainty as to the amount of revenue we will receive from such agreements; our significant operating costs as a public company; potential cyber attacks on our IT systems or the IT systems of our third-party vendors, which could disrupt our operations; our potential inability to repay secured debt we have incurred with third party lenders, and the restrictions on our business activities that are contained in our loan agreement with these lenders; the risk that our strategic realignment and restructuring plans for 2020 result in unanticipated costs or revenue losses; the uncertainty as to the amount of royalties we will receive from the sale of Mirataz® to Dechra Pharmaceuticals PLC; the risk that the income from our provision of services or products under a contract will be less than what we expect if the other party to the contract exercises its right to terminate the contract before the completion of the contract or if that party is unable or unwilling to meet their payment obligations under the contract; our potential inability to obtain and maintain patent and other intellectual property protection for our products and product candidates; potential claims of 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 the price of our shares; and the significant control over our business by our major shareholders and management.

For a more detailed description of these and other risks we face, please see the risk factors described in our filings with the United States Securities and Exchange Commission (SEC), including risk factors discussed under “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. Due to the risks described above and in our documents filed with the SEC, actual results may differ materially from those indicated by the forward-looking statements contained in this press release. The forward-looking statements contained in this press release speak only as of the date of this press release, and we assume no obligation to update or revise such statements, except as required by law.

Contacts

For investor inquiries:

Katja Bührer

Katja.buhrer@kindredbio.com

(917) 969-3438

1 American Kennel Club Canine Health Foundation. Canine Parvovirus Information for Dog Owners. June 2018. Available at: 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 the Pet Health report compiled from the medical data of 2.3 million dogs treated at the 2013 Banfield Pet Hospitals.

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SOURCE Kindred Biosciences, Inc.



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