A new product targeting Equine Gastric Ulcer Syndrome in horses is a step closer to being available commercially with the start of a dose determination study.
Jaguar Animal Health is determining the commercial dose of its new product, SB-300, a pharmaceutical formulation of a standardized botanical extract.
The 30-day randomized, blinded, controlled, multisite dose determination study is being performed on about 100 racehorses aged two and older.
All enrolled horses have been diagnosed with glandular and squamous gastric ulcers via gastroscopy before treatment, and will be evaluated after 14 and 28 days during treatment.
Enrolled horses will be randomized to one of four groups each containing about 25 animals. The “a” group will receive 5 grams of SB-300 every 12 hours; those in the “b” group will receive 2.5 grams of SB-300 every 12 hours; and those in the placebo group will receive a placebo every 12 hours. Horses in the fourth group will receive the FDA-approved recommended dosage of omeprazole once a day. The percentage of horses in each group with a reduction in the number and severity (improvement or complete resolution) of gastric ulcerations will be compared to determine the proposed dosage for SB-300.
Jaguar announced earlier this year that its proof-of-concept study to evaluate the safety and effectiveness of SB-300 indicated that 78 to 89% of horses treated with the product had resolution or improvement of glandular ulcers as soon as 14 days during treatment.
A further analysis of the results indicated that SB-300 did not alter gastric pH during the 28-day trial, or for 7 days after therapy. This is important because maintaining low gastric pH is essential for digestion, for gut immunity and first line defense against pathogens, for the absorption of vitamins and minerals, and for potentially additional downstream effects.
Standard drug testing in racehorses that received SB-300 did not detect any substances commonly disallowed by horse racing authorities.
According to a 2005 study, as many as 55% of performance horses have both colonic and gastric ulcers, and 97% of performance horses have either a gastric (87%) or a colonic (63%) ulcer.*
* Pellegrini FL. Results of a large-scale necroscopic study of equine colonic ulcers. J Equine Vet Sci. 2005;25(3):113-117.