A tree extract which is a candidate for treating diarrhea associated with acute colitis in horses produced no adverse effects during a pilot safety study.
The positive results for crofelemer, an active pharmaceutical ingredient isolated and purified from the Croton lechleri tree, has been announced by San Francisco-based Jaguar Animal Health.
The firm, which develops and commercializes gastrointestinal products for animals, had initiated the research earlier this month in conjunction with Louisiana State University.
The study involved three healthy horses treated with three consecutive, three-day cycles of escalating dose levels (up to about eight times the proposed dosage in horses) of an oral crofelemer paste.
Clinical observations, vital signs, biochemical changes (a complete blood count, serum chemistry and urinalysis) and adverse events were evaluated for dose-limiting toxicity after each dose level.
Dose-limiting toxicities were not observed at any of the three dose levels.
“The results of this pilot study in horses are consistent with our findings on the safety of crofelemer in several other species, and permit us to proceed confidently with our development program in horses,” said Jaguar’s president and chief executive, Lisa Conte.
“Part of that development program concerns the use of crofelemer for the treatment of diarrhea associated with acute colitis.”
Colitis is inflammation of the large bowel. It can affect adult horses as well as foals.
Acute colitis can cause sudden, massive fluid loss and severe electrolyte imbalances that can result in death.
Acute colitis often occurs when Salmonella and Clostridium difficile – bacteria that are normally present in the gut – are activated by stress, or when the rickettsia Neorickettsia risticii is ingested, causing Potomac Horse Fever, which has been studied as a secretory type of diarrhea by third parties.
Stress (from the likes of shipping, changes in daily routines, illness, hospitalization, surgery, racing), recent diet changes, recent antimicrobial administration, and non-steroidal anti-inflammatory drug therapy can also put horses at risk for acute colitis.
Jaguar currently has nine active investigational new animal drug applications filed with the US Food and Drug Administrations.