Kindred Biosciences Initiates Pivotal Efficacy Study of Tirnovetmab (Interleukin-31) Monoclonal Antibody for Canine Atopic Dermatitis

Rhea-AI Summary

Kindred Biosciences, Inc. (NASDAQ: KIN) announced the initiation of a pivotal efficacy study for tirnovetmab, a monoclonal antibody targeting interleukin (IL)-31 to treat atopic dermatitis in dogs. Affects 10-15% of dogs globally, with a market size nearing $900 million. CEO Richard Chin emphasized a strong demand for new biologics, citing over 70% of veterinarians seeking alternatives. The study marks a significant milestone for KindredBio and aligns with their strategy to develop innovative therapies for pets.

Positive

• Initiation of pivotal study for tirnovetmab, potentially a blockbuster product.
• The atopic dermatitis treatment market is estimated at $900 million and growing.
• Over 70% of veterinarians indicate a need for new biological treatment options.

Negative

• None.

SAN FRANCISCO, Dec. 22, 2020 /PRNewswire/ -- Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced that it has initiated the pivotal efficacy study for tirnovetmab (KIND-016), a fully caninized, high-affinity monoclonal antibody targeting interleukin (IL)-31 for the treatment of atopic dermatitis in dogs.

Atopic dermatitis is the most common reason owners take their dog to the veterinarian, and is estimated to affect 10 - 15% of dogs worldwide¹. The current market size is close to $900 million annually and growing. 

"Commencement of the tirnovetmab pivotal study marks an important milestone for KindredBio," said Chief Executive Officer, Richard Chin, M.D. "The market for canine atopic dermatitis, allergic dermatitis, and other pruritic diseases already rivals that of many successful human drugs, and continues to experience strong growth. Our market research has found that more than 70% of veterinarians, and a higher percentage of dermatologists, desire a new biological treatment option for pruritic dogs². We believe tirnovetmab is a very promising product candidate with the potential to be a blockbuster, and we continue to pursue a portfolio of additional monoclonal antibodies to fully address this market opportunity."

Other programs in development for atopic dermatitis include KIND-032, a fully caninized monoclonal antibody targeting IL-4R. A second pilot study to further assess dosing commenced in the third quarter of 2020.

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 of 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 or to develop a satisfactory sales organization for our equine small molecule products; 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; 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 results stated in this press release have not been reviewed by the Food and Drug Administration or the United States Department of Agriculture Center for Veterinary Biologics, as applicable.

Contacts

For investor inquiries: 
Katja Buhrer
Katja.buhrer@kindredbio.com 
(917) 969-3438

¹ Hillier, A. and C.E. Griffin, The ACVD task force on canine atopic dermatitis (I): incidence and prevalence. Vet Immunol Immunopathol, 2001. 81(3-4): p. 147-51.
¹ Website, N.P.I. Top 10 Medical Conditions of 2016. Available from: https://www.prnewswire.com/news-releases/most-common-medical-conditions-for-dogs-and-cats-300418097.html 
² Source: 2019 Canine Atopic Dermatitis Veterinarian Research, February, 2019 (n=173 U.S. small animal veterinarians and dermatology specialists).  Data on file at Kindred Biosciences

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SOURCE Kindred Biosciences, Inc.

FAQ

What is tirnovetmab and its significance for Kindred Biosciences?

Tirnovetmab is a monoclonal antibody targeting IL-31, marking a pivotal study for treating atopic dermatitis in dogs and potentially a blockbuster product for Kindred Biosciences.

What market size does the atopic dermatitis treatment hold?

The market for canine atopic dermatitis treatments is approximately $900 million annually and is experiencing growth.

What percentage of veterinarians seek new treatments for canine dermatological issues?

Over 70% of veterinarians desire new biological treatment options for pruritic dogs, indicating strong demand.

When was the pivotal efficacy study for tirnovetmab initiated?

The pivotal efficacy study for tirnovetmab was announced on December 22, 2020.

What company announced the pivotal study for tirnovetmab?

The pivotal study for tirnovetmab was announced by Kindred Biosciences, Inc. (NASDAQ: KIN).