Jaguar Animal Health Reports Topline Findings for its 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
In this prospective, blinded, randomized, negative controlled study, Standardbred or Thoroughbred racehorses were randomized to one of three groups (10 horses per group) and treated for 28 days: horses in the placebo group received water-filled syringes every 6 hours; those in the TRT5 group received 5 grams of SB-300 divided into 2 doses per day; and those in the TRT40 group received 40 grams of SB-300 divided into 4 doses per day. Strict enrollment criteria required patients to have both squamous (non-glandular) and glandular gastric ulcerations. All horses were examined by gastroscopy (stomach endoscope) by blinded equine investigators on Day 0 (prior to treatment; baseline), and on Day 14 (mid-study), Day 28 (last day of treatment) and Day 35 (7 days after last treatment). Treatment-related adverse events were not observed.
With respect to glandular ulcerations, a statistically significantly greater number of horses in both the TRT40 (89%) and the TRT5 (78%) group had an improvement or a resolution of glandular ulcerations, compared with the placebo (25%) group as soon as Day 14. By Day 35, all of the SB-300 treated horses had experienced improvement or resolution, whereas 25% of horses in the placebo group still had not improved or resolved during the study.
With respect to squamous ulcerations, a non-statistically significant dose-dependent effect was observed with 40% and 33% of horses achieving an improvement or a resolution by Day 14 in the TRT40 and TRT5 groups, respectively, compared with 11% of placebo horses. By Day 35, numerically more horses in the TRT40 (60%) and TRT5 (55%) groups had achieved an improvement or a resolution compared with 33% of placebo horses.
Jaguar will be releasing additional findings from this study after further analysis of the data.
As Jaguar stated on
According to a third-party 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.3
Data from the
For more information, please visit www.jaguaranimalhealth.com.
Certain statements in this press release constitute “forward-looking
statements.” These include statements regarding Jaguar’s plans to
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.,
3Pellegrini FL (2005). Results of a large-scale necroscopic study of equine colonic ulcers. J Equine Vet Sci; 25 (3): pp. 113-117.