Fuzapladib in a randomized controlled multicenter masked study in dogs with presumptive acute onset pancreatitis.

BACKGROUND: Currently, no specific treatment is available for acute onset pancreatitis (AP), and management relies on symptomatic and supportive standard of care (SOC). Fuzapladib is a novel leukocyte function-associated antigen type-1 (LFA-1) activation inhibitor, blocking activation and subsequent adhesion and migration of neutrophils, potentially decreasing the risk of pancreatitis progression and systemic inflammation. OBJECTIVE: Evaluate the safety and clinical response of dogs with AP after 3 days of administration of fuzapladib. ANIMALS: Sixty-one client-owned dogs with presumptive AP. METHODS: Randomized, masked, and placebo controlled multicenter study. Sixty-one dogs with AP were included for safety assessment, whereas 35 evaluable cases (fuzapladib, n = 16; placebo, n = 19) were included for clinical evaluation. Clinical improvement was assessed based on the change in the modified clinical activity index (MCAI) score on Day 3 compared to Day 0. Secondary variables included canine acute pancreatitis clinical severity index (CAPCSI) scores and serum concentrations of canine pancreatic lipase immunoreactivity, cytokines, and C-reactive protein. RESULTS: Fuzapladib was well tolerated by all treated dogs. Mean change in MCAI scores was significantly higher in the fuzapladib-treated (-7.75) than the placebo group (-5.68; P = .02, 95% confidence interval [CI] for the difference, -4.33, -0.35), suggesting clinical improvement in fuzapladib-treated dogs. No significant difference was found in any of the secondary variables between groups. CONCLUSIONS AND CLINICAL RELEVANCE: Administration of fuzapladib to dogs was safe, and a favorable response was detected in 2 clinical activity scores. Effects of fuzapladib on survival and duration of hospitalization were not studied.

Comparative study to evaluate the voluntary acceptance of two liquid oral formulations of ciclosporin in dogs.

BACKGROUND: The purpose of this study was to determine and compare the voluntary acceptance of two oral liquid formulations of ciclosporin, investigational Atopica® oral solution (Elanco Animal Health) and Cyclavance® Oral Solution (Virbac), when given orally via syringe or offered freely after mixing with food to dogs.Twenty-five adult mixed breed dogs were selected for this two-phase study. In Phase 1, 12 (Group I) and 13 (Group II) dogs received Atopica® oral solution and Cyclavance® Oral Solution, respectively, daily for 7 days via an oral syringe. After a 3-day washout period, the dosing was switched for a further 7 days. For Phase 2, dosing was by acceptance from freely offered test article mixed in a small amount of food, approximately 6 h after the routine morning feeding. During the first part of this phase, normal daily ration of food offered in the morning was continuously left in the cage. Group I was offered Atopica® oral solution and Group II was offered Cyclavance® Oral Solution mixed with ~ 25 g of food for 3 days. After another 2-day washout period, the test articles were switched for another 3 days but the animals received food for only 1 h in the morning. Five hours after the food was removed, the test articles with food were offered in the same manner as in the first part of Phase 2. Animals were also monitored for adverse events (AEs). RESULTS: During Phase I, voluntary acceptance rates of 100 and 98.9% were noted for Atopica® oral solution and Cyclavance® Oral Solution, respectively. The corresponding immediate prehension rates during Phase 2 (Period 1) were 61.1 and 56.4%, respectively. During Phase 2 (Period 2), the immediate prehension rates were 69.2, 69.4 and 92.0% for Atopica® oral solution, Cyclavance® Oral Solution and the positive control (DYNE®; High Calorie Liquid Dietary Supplement), respectively. Two adverse events of diarrhea and vomiting, with a probable relationship to the test articles, were reported. CONCLUSION: There was no significant difference in acceptance of the two oral ciclosporin solutions, the investigational Atopica® oral solution (Elanco) and Cyclavance® (Virbac) for dogs.