SAN FRANCISCO, CA (January 14, 2019) Kindred Biosciences, Inc. (NASDAQ: KIN), a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets, today announced positive topline results from its pilot field effectiveness study of epoCat (KIND-510a), a long-acting feline recombinant erythropoietin that is being developed for the management of anemia in cats.
In the study, which enrolled 23 cats with anemia, epoCat rapidly increased mean hematocrit (a measure of red blood cell count), with statistically significant improvement seen as early as Week 1 (p<0.0001). The effect was sustained, with continued statistically significant improvement at Weeks 2, 3, 4, 5, and 6 (p<0.0001 at each visit). Compared to baseline, the mean peak improvement in hematocrit was 55.4%.
In addition, 95.5% of the 22 evaluable patients achieved treatment success over the 6-week treatment period, defined prospectively as either a 30% increase in hematocrit value over baseline or the hematocrit value reaching normal range. Furthermore, cats treated with epoCat demonstrated statistically significant improvements over baseline (p<0.01 to p<0.05) across all three health-related quality of life (QoL) domains, Vitality, Comfort, and Emotional Wellbeing, as measured by a validated QoL instrument. Based on a preliminary review of the safety data, the drug appears to be well tolerated.
The Company plans to commence a pivotal study this year and is currently in discussions with the Food and Drug Administration (FDA) regarding study design. The FDA has agreed to accept hematocrit as the primary endpoint for the pivotal study.
epoCat is a recombinant feline erythropoietin that has been engineered by KindredBio to have a prolonged half-life. Erythropoietin is an endogenous protein that regulates and stimulates production of red blood cells.
Anemia is a common condition that is estimated to afflict millions of older cats. It is often associated with chronic kidney disease, because kidneys produce erythropoietin and chronic kidney disease leads to decreased levels of endogenous erythropoietin. Chronic kidney disease affects approximately half of older cats, making it a leading cause of feline mortality. Human erythropoietins, which are multi-billion dollar products in the human market, are immunogenic in cats.
“Feline anemia is an important unmet medical need. Currently, there are no approved treatment options for this disease and we are impressed with these results,” stated Richard Chin, CEO of KindredBio. “We look forward to helping patients, and we believe epoCat has the potential to be a major commercial success. This is our third consecutive positive efficacy study in our biologics pipeline, following positive efficacy results in the IL31 antibody study in canine atopic dermatitis and in the TNF antibody study in septic foals. This reinforces our position as a market leader in the veterinary biologics space.”
In addition, KindredBio announced that Mirataz® (mirtazapine transdermal ointment) is now available for order at Banfield Pet Hospital. Furthermore, the Company has established a partnership with the American Animal Hospital Association to provide ongoing education efforts to its more than 43,000 members.
“The inclusion of Mirataz in the two largest U.S. corporately owned veterinary groups of pet hospitals within six months of launch is a testament to our commercial team,” said Denise Bevers, President and COO of KindredBio. “We are pleased to have achieved our 2018 goal of having Mirataz in one third of veterinary clinics, and to have delivered strong revenue growth quarter-over-quarter. We are likewise encouraged by healthy reorder trends by both clinics and distributors, and positive customer feedback to date. We look forward to presenting a comprehensive financial overview and more detail on these positive study results in our year-end call.”
KindredBio will hold its fourth quarter 2018 financial call on Wednesday, March 6, 2019. Details for the conference call and webcast will be forthcoming.
About Kindred Biosciences
Kindred Biosciences is a commercial-stage biopharmaceutical company 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 compounds and targets that have already demonstrated safety and efficacy in humans and to develop therapeutics based on these validated compounds and targets for dogs, cats and horses. The Company has a deep pipeline of novel drugs and biologics in development across many therapeutic classes. KindredBio’s first approved drug is Mirataz® (mirtazapine transdermal ointment) for the management of weight loss in cats.
Important Safety Information
Mirataz® (mirtazapine transdermal ointment) is for topical use in cats only under veterinary supervision. Do not use in cats with a known hypersensitivity to mirtazapine or any of the excipients or in cats treated with monoamine oxidase inhibitors (MAOIs). Not for human use. Keep out of reach of children. Wear gloves to apply and wash hands after. Avoid contact with treated cat for 2 hours following application. The most common adverse reactions include application site reactions, behavioral abnormalities (vocalization and hyperactivity) and vomiting. Please see the full Prescribing Information.
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