Jaguar Animal Health (JAGX) Reports Final Topline Data from Crofelemer Proof-of-Concept Study; Sees Filing Canalevia NADA in 2017

October 18, 2016 9:03 AM EDT
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Jaguar Animal Health, Inc. (Nasdaq: JAGX) announced final topline results today 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.

Crofelemer is isolated and purified from Croton lechleri, a tree that is sustainably harvested and contains anti-secretory properties. Crofelemer has demonstrated efficacy in numerous human clinical trials of acute watery diarrhea induced by various infectious pathogens. A human-specific formulation of crofelemer was approved by the U.S. Food and Drug Administration in 2012 for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy, often a chronic problem, and was launched commercially by Napo Pharmaceuticals, Inc. last week under the tradename Mytesi™.

The crofelemer proof-of-concept study was comprised of two stages. Stage 1 was a randomized, double-blind, placebo-controlled stage to assess the efficacy of crofelemer administered orally in alleviating clinical signs associated with secretory diarrhea in dogs, and to assess the safety of the product candidate. Stage 2 of the study was an open-label continuation of the safety assessment of crofelemer for the same indication and was not placebo-controlled. During Stage 1, 61 dogs were evaluated, and 53 dogs were evaluated during Stage 2.

During Stage 1, dogs exhibiting a fecal score of 4 (watery, liquid stool) or 5 (severe watery diarrhea) on a scale of 1 to 6 were randomized to receive either an enteric-coated crofelemer formulation, or a matching enteric-coated placebo formulation, administered twice a day for 72 hours, in addition to receiving standard of care therapy. Stool consistency and frequency were assessed at multiple time periods daily during the in-life portion of the study, which consisted of a 72-hour treatment period, followed by an observation period.

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 (91.0%) that achieved formed stools (a fecal score of 1 or 2) during the evaluation period versus placebo-treated animals (50.0%), 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 (93.1%) that achieved formed stools (a fecal score of 1 or 2) during the evaluation period versus placebo-treated animals (68.8%), 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.

“We’re very pleased that the results for the additional 22 dogs enrolled in Stage 1 of the proof-of-concept study support the conclusion that crofelemer has the potential to serve as an effective new tool in the treatment of canine secretory diarrhea, and that these data are consistent with the power calculations for our ongoing field study to support approval of Canalevia™ for acute diarrhea,” stated Lisa Conte, Jaguar’s president and CEO. “We estimate that U.S. veterinarians see approximately six million annual cases of acute and chronic watery diarrhea in dogs. Devastating dehydration can occur rapidly for the animal, and the lack of control in urban settings where owners don’t have easy access to outdoor facilities is a real problem for dog-owning families.”

As the Company announced on April 13, 2016, it has obtained protocol concurrence from the Center for Veterinary Medicine (“CVM”) of the U.S. Food and Drug Administration for the Canalevia™ pivotal field study. Protocol concurrence for the pivotal study was achieved following a discussion with CVM of the clinical relevance of the results of the interim analysis Jaguar conducted on the initial 39 dogs enrolled in Stage 1 of the crofelemer proof-of-concept study.

“Following discussions with CVM regarding the clinical relevance of the proof-of-concept study and discussions about our clinical trial rigor in the ongoing field trial, which involves collecting data during the 72-hour treatment period with a 24-hour observation period, Jaguar and CVM agreed that the pivotal study protocol for Canalevia™ would define a responder as a dog that does not exhibit watery stool for a 16-hour window during the 72-hour study period or during the following 24-hour observation period,” explained Dr. Michael Guy, a Jaguar vice president and clinical veterinarian.

Jaguar expects to file the new animal drug application (“NADA”) 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 (INAD) file for Canalevia™ for chemotherapy-induced diarrhea (“CID”) in dogs, for which it has received MUMS designation.

Diarrhea is one of the most common reasons for veterinary office visits for dogs and is the second most common reason for visits to the veterinary emergency room, yet there are currently no FDA-approved anti-secretory agents to treat acute diarrhea in dogs. According to the American Veterinary Medical Association, there were approximately 70 million dogs in the United States in 2012.

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