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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
"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,
As detailed in a
"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
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.
For more information, visit: www.kindredbio.com
This press release contains forward-looking statements within the meaning of the
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
The canine parvovirus monoclonal antibody is not yet licensed by the
For investor inquiries:
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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