Overview of Canalevia™ Dog Field Trial for Participating Animal Shelters

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Summary of the Trial Protocol:
Dogs with acute diarrhea are being enrolled in this randomized, blinded and placebo-controlled study. Under the supervision of a licensed veterinarian, the dogs undergo a complete physical exam, a fecal analysis, and blood and urine sampling. No invasive procedures other than blood and urine sampling are conducted on the dogs. Upon meeting eligibility requirements, dogs are dosed and fed twice daily and all feces produced is observed and scored per the Purina Fecal Score (PFS) Guide for 72 hours followed by fecal observation only for an additional 24 hours. Total time on study will be 4 days.

Primary Objective:
This clinical study will confirm the field safety and effectiveness of crofelemer (SP-303) for the treatment of acute diarrhea in dogs acquired through select veterinary clinics, humane societies, shelters and rescues within the contiguous 48 states.

Key Inclusion Criteria:
• Signed informed consent
• Dogs with current acute diarrhea of a 6 or 7 as scored by the Purina Fecal Score Guide
• Dogs >8 weeks, >5lbs

Key Exclusion Criteria:
• Dogs with chronic diarrhea
• Dogs with hemorrhagic diarrhea
• Dogs positive for parvo and/or parasites

Summary of the Drug Candidate:
Diarrhea can be a regular occurrence in dogs housed in shelters. One of the most common types of diarrhea is secretory diarrhea, although there are currently no animal health products available with anti-secretory properties. Crofelemer, the active pharmaceutical ingredient in Jaguar’s Canalevia™ drug product candidate, is sustainably harvested from the latex of an Amazon rainforest tree called Croton lechleri. A human-specific tablet formulation of crofelemer, Fulyzaq™, 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. Crofelemer is not absorbed systemically but acts locally within the gastrointestinal tract. Crofelemer shows promise in treating diarrhea without affecting intestinal motility in several animal species including dogs. The canine-specific formulation of crofelemer to be tested in this field trial is a tablet called Canalevia™.

Contact Information:
Please contact Dr. Michael Guy at [email protected] or 415-896-2582 if your organization is interested in participating as a study site.