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The study was a randomized, blinded, placebo-controlled, pilot field study that enrolled 62 client-owned dogs with atopic dermatitis to assess the effectiveness of KIND-016. A single dose of KIND-016 or placebo was administered on day 0, and the severity of pruritus (Pruritic Visual Analog Scale [PVAS score]) and atopic dermatitis severity (Canine Atopic Dermatitis Extent and Severity Index-4 [CADESI-4 score]) were assessed at day 0 and weeks 1, 2, 3, 4, 6, and 8. Additionally, PVAS scores were assessed at 4 hours and days 1, 2 and 3 post-administration of KIND-016 or placebo. Treatment success for individual dogs at each visit was defined as a 50% or higher reduction from baseline in either the PVAS or CADESI-4 scores. The primary efficacy endpoint was proportion of treatment successes at week 4 in the per-protocol population. The primary effectiveness analysis was the 95% confidence interval (CI) for the treatment effect.
At week 4, 60.7% of the KIND-016 group met treatment success criteria, vs. 33.3% of the placebo group (p=0.0420, 95% CI -0.0033, 0.6539). The reduction in itching, as measured by the PVAS score, peaked rapidly, showing significant efficacy as early as 24 hours with a trend as early as 4 hours. The CADESI response was also very rapid, with treatment success rate reaching 70% as early as week 1 in the KIND-016 group. While the study was not powered to demonstrate efficacy beyond week 4, the majority of dogs who were treatment successes at week 4 maintained response through week 8.
"We are delighted by the positive results of this study. Atopic dermatitis, allergic dermatitis, and other pruritic diseases constitute an enormous market, now at
KindredBio will hold a call to discuss and answer questions on the results of the pilot field effectiveness study at
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1Hillier, A. and
1Website, 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
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