Jaguar Animal Health says data confirm conclusion crofelemer superior to placebo
Jaguar Animal Health announced final topline results for the multicenter proof-of-concept study the company conducted in 2015 to evaluate the safety and efficacy of crofelemer, the active pharmaceutical ingredient in Jaguar's Canalevia prescription drug product candidate, for treatment of secretory, or watery, diarrhea in dogs. On February 19, 2015, Jaguar announced the results of an interim analysis of data from Stage 1 of the study. The interim analysis was based on 39 dogs with secretory diarrhea that took part in the study up to February 12, 2015. The statistically significant results for the 39-dog group showed crofelemer treatment to be superior to placebo in a resolution analysis of diarrhea, measured as a percentage of crofelemer-treated dogs that achieved formed stools during the evaluation period versus placebo-treated animals, with a p-value of 0.007. From February 12, 2015 to February 19, 2015, an additional 22 dogs with secretory diarrhea were enrolled in Stage 1 of the study. The results for the combined group of 61 Stage 1 dogs were also statistically significant, showing crofelemer treatment to be superior to placebo in the resolution of diarrhea, measured as a percentage of crofelemer-treated dogs that achieved formed stools during the evaluation period versus placebo-treated animals, with a p-value of 0.0237. Jaguar is in the midst of a final pivotal field study to evaluate the safety and efficacy of Canalevia for treatment of acute diarrhea in dogs. An estimated 200 dogs will be enrolled in the Canalevia pivotal study, which is expected to complete enrollment around the end of 2016. Jaguar expects to file the new animal drug application for Canalevia in 2017 for the indication of acute diarrhea in dogs and to conduct the commercial launch of the product, if it is approved. Jaguar has also established an investigational new animal drug file for Canalevia for chemotherapy-induced diarrhea in dogs, for which it has received MUMS designation.