Jaguar Animal Health, Inc., an animal health company focused on developing and commercialising first-in-class gastrointestinal products for companion and production animals, foals, and high value horses, announced that it has obtained protocol concurrence from the Center for Veterinary Medicine (CVM) of the US Food and Drug Administration (FDA) to amend the protocol for the company’s ongoing clinical field study for Canalevia and utilize a 125-mg tablet of a formulation manufactured according to processes and quality standards currently approved by the FDA.

Canalevia is Jaguar’s lead prescription drug product candidate, intended for the treatment of diarrhea in dogs. Jaguar’s pivotal field study (CANA-003) is being conducted in support of the company’s filing of a new animal drug application (NADA) for Canalevia for the treatment of acute diarrhea in dogs. This prospective, blinded, randomized, placebo-controlled study was initiated in December of last year and is being conducted on an inpatient basis at animal shelters and animal rescues across the US. The study will enroll at least 150 dogs exhibiting watery diarrhea, and is expected to be completed in the second half of 2016.

Jaguar has submitted to the FDA all required major technical sections towards conditional approval of Canalevia for dogs suffering from chemotherapy-induced diarrhea, or “CID,” a minor use in a major species (MUMS). MUMS is an FDA drug designation, similar to the orphan drug designation in humans, which is typically limited to the use of a drug to treat disease that occurs infrequently or in a small number of animals. FDA encourages sponsors to seek MUMS designation and conditional approval of qualifying drugs to address unmet medical needs in the veterinary industry. Canalevia will be the same commercial formulation for both the CID and acute diarrhea indications.

“Utilizing a 125-mg tablet simplifies the product presentation to just one tablet strength—allowing users to safely administer one or two tablets depending on dog weight, reduces product development costs for registration batches and stability studies, and leverages the Chemistry Manufacturing and Controls filing, used in both the conditional approval of Canalevia and in the broader NADA acute diarrhea programme,” commented Philippe Brianceau, DVM, Jaguar’s chief veterinary officer.

Lisa Conte, Jaguar’s president and CEO, added, “Obtaining protocol concurrence by CVM is a key milestone that aligns the development of the 125-mg crofelemer tablet for both the treatment of CID and the treatment of acute diarrhea in dogs with the same dosage form for the human FDA-approved formulation of crofelemer.”

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 canine diarrhea. According to the American Veterinary Medical Association, there were approximately 70 million dogs in the United States in 2012. Jaguar estimates that US veterinarians see approximately six million annual cases of acute and chronic 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 significant problem for families with dogs.

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.