Jaguar Animal Health Announces Final Topline Results for Proof-of-Concept Study for Secretory Diarrhea in Dogs
Statistically Significant Final Results Confirm Interim Conclusion That Crofelemer Treatment is Superior to Placebo
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
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.
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
As the Company announced on
“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.
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
Canalevia™ is Jaguar’s lead prescription drug product candidate for the treatment of various forms of diarrhea in dogs. Canalevia™ is a canine-specific formulation of crofelemer, an active pharmaceutical ingredient isolated and purified from Croton lechleri, a tree that is sustainably harvested and contains anti-secretory properties. The product is an oral, enteric-coated, twice daily formulation of crofelemer that acts locally in the gastrointestinal tract. It acts at the last physiological step, conserved across mammalian species, in the manifestation of acute diarrhea.
Mytesi™ (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi™ is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi™. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%).
More information and complete Prescribing Information are available at Mytesi.com.
For more information, please visit www.jaguaranimalhealth.com.
Certain statements in this press release constitute “forward-looking statements” within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934. These include statements regarding the expected completion of enrollment around the end of 2016 for Jaguar’s pivotal study for Canalevia™, the estimate that 200 dogs will be enrolled in the Canalevia™ pivotal study, the Company’s plans to file the new animal drug application (“NADA”) for Canalevia™ for the indication of acute diarrhea in dogs in 2017, Jaguar’s plan to conduct the commercial launch of Canalevia™ for the indication of acute diarrhea in dogs, if the product is approved, Jaguar’s plan to develop formulations of Equilevia™ in horses and species-specific formulations of Neonorm™ in additional target species, and Jaguar’s plan to develop formulations of Canalevia™ for cats and dogs. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
KCSA Strategic Communications
Garth Russell, 212-896-1250