Jaguar Animal Health Initiates Proof-of-Concept Study to Evaluate the Safety and Effectiveness of an Investigational New Animal Drug Candidate for the Treatment of Gastrointestinal Ulcers in Horses
Stall confinement, stress, intermittent feeding, intense exercise and administration of non-steroidal anti-inflammatories are factors that may lead to gastric ulcers in horses1 and, frequently, in performance equine athletes. Horses with gastric ulcers may perform poorly, which makes this condition a sizable economic as well as health problem within the horse industry2.
The Amazonian herbal medicine Sangre de Grado, which, like SB-300, is derived from the Croton lechleri tree, has been used in traditional medicine in humans for thousands of years for ulcers and gastric distress and has been shown to be an effective anti-ulcerogenic agent in rats3, 4. SB-300 acts locally in the gastrointestinal tract with minimal systemic absorption, a key factor for the safety of the product. Additionally, SB-300 has no effect on gut motility and there have been no significant drug-drug interactions identified to date.
Jaguar’s prospective, masked, randomized, negative controlled study will enroll horses with gastric ulcers. Participating animals will be dosed for 28 consecutive days and will undergo gastroscopy every 14 days, during which gastric ulcer scores and gastric pH will be recorded. Study results are expected to be available by the end of the year.
According to a third-party 2005 study, 54% of performance horses have
both colonic and gastric ulcers and 97% of performance horses have
either a gastric (87%) or a colonic (63%) ulcer.5 Data from
Jaguar announced this past September that it recently initiated a
proof-of-concept study in
Additionally, Jaguar is planning trials to develop an equine-specific formulation of crofelemer for the treatment of diarrhea associated with acute colitis, a devastating and dehydrating condition that can lead to patient death in less than 24 hours. Crofelemer is an active pharmaceutical ingredient isolated and purified from the Croton lechleri tree. The Company intends to seek MUMS (minor use in a major species) designation for the product.
“Jaguar is developing a full suite of products to support and improve
gastrointestinal health in foals and adult horses,” stated
The Neonorm™ extract is also the core ingredient in Neonorm™ Calf, the Company’s lead non-drug product, and in Neonorm™ Foal. Jaguar currently owns enough of this extract to formulate a combination of approximately one million doses of Neonorm™ Calf or Neonorm™ Foal.
For more information, please visit www.jaguaranimalhealth.com.
Certain statements in this press release constitute “forward-looking
statements.” These include statements regarding the availability, before
year-end, of results from Jaguar’s proof-of-concept study to evaluate
the safety and effectiveness of SB-300 for the treatment of
gastrointestinal ulcers in horses, the availability, in the next few
weeks, of results from Jaguar’s proof-of-concept study in
1Habershon-Butcher, J.L., Hallowell, G.D., Bowen, I.M.,
Sykes, B., 2012. Prevalence and risk factors for ulceration of the
gastric glandular mucosa in thoroughbred race horses in training in the
2Vatistas, N.J., Synder, J.R.,
3Cordeiro KW, Pinto LA, Nazari Formagio AS et al. Antiulcerogenic effect of Croton Urucurana Baillon bark. Journal of ethnopharmacology 143 (2012) 331-337.
4Miller MJ, MacNaughton WK, Zhang XJ et al. Treatment of gastric ulcers and diarrhea with the Amazonian herbal medicine sangre de grado. Am J Physiol Gastrointest Liver physiol 279 (2000) 192-200.
5Pellegrini FL (2005). Results of a large-scale necroscopic study of equine colonic ulcers. J Equine Vet Sci; 25 (3): pp. 113-117.
KCSA Strategic Communications
Garth Russell, 212-896-1250