Jaguar Animal Health Issues Racing Data Summary for Horses Participating in the Company’s Recently Completed Dose Determination Study for its Drug Product Candidate for Equine Gastric Ulcer Syndrome
A Full Analysis of the Study Data with Scoring of Squamous and Glandular Ulcers is Expected to be Available in January
Equilevia™ is a pharmaceutical formulation of a standardized botanical extract. The randomized, blinded, controlled, multisite dose determination study enrolled 121 racehorses two years of age or older. All enrolled horses were diagnosed with glandular and squamous gastric ulcers. The primary objective of the study was to select the minimally effective dose of Equilevia™ for the treatment of equine gastric ulcers in a future pivotal field study.
Horses on treatment with Equilevia™ had higher average winnings as a percent of purse in races during the study treatment period compared with the period in which they raced prior to the study. Horses on placebo or on the positive control (Merial’s GASTROGARD® product) had a reduction in their average winnings as a percent of purse during the study treatment period compared with the period in which they raced prior to the study.
Additionally, horses on treatment with Equilevia™ had higher average total dollar winnings in races during the study period compared with the period in which they raced prior to the study. However, horses on placebo had a reduction in total earnings in races during the study period compared with the period in which they raced prior to the study, whereas horses on GASTROGARD® had essentially no change in their earnings in races compared with the period in which they raced prior to the study.
When analyzing data according to whether or not a horse finished a race in the top 3 or in the top 5, there was also an improvement seen for horses treated with Equilevia™ during the study treatment period compared with the period in which they raced prior to the study. Horses treated with placebo, however, had a reduction in frequency of finishing in the top 3 or in the top 5 in the study period compared with the period in which they raced prior to the study.
No statistically significant comparisons were generated for the aforementioned exploratory analyses.
“Racing results in horses treated with Equilevia™ during our
dose determination study are of interest because ulcers are a particular
problem in equine athletes,” stated
During the dose determination study, endoscopies were obtained at
baseline, prior to the start of treatment, on day 15 and finally on day
29 of treatment. The equine veterinarians performing the endoscopies
were blinded to the treatment assignment, and the Company is also
blinded to these data at this time. A full analysis of the dose
determination study data with scoring of squamous and glandular ulcers
is awaiting an independent, blinded review by an equine veterinarian
experienced in gastric ulcer disease, and is expected to be available
this coming January. Review will include comparisons of more than one
scoring system in order to identify the best means of assessing clinical
improvement of both squamous and glandular lesions for a proposed
primary endpoint. Jaguar’s intention is to identify a scoring system
that most appropriately demonstrates clinical change in both squamous
and glandular ulcers, and the Company plans to seek concurrence from the
“We believe independent analysis of the endoscopy data from this study
is highly important—both to ensure consistency of grading and to
determine the most clinically relevant endpoint scoring system for our
planned field trial,” commented Dr.
As Jaguar announced this past January, topline results from its proof-of-concept study to evaluate the safety and effectiveness of Equilevia™ indicate that 78 to 89% of horses treated with Equilevia™ (depending on dose) had resolution or improvement of glandular ulcers as soon as 14 days during treatment. As Jaguar announced this past February, further analysis of the results of the proof-of-concept study indicates that Equilevia™ did not alter gastric pH during the 28-day trial, or for 7 days after therapy. A treatment for EGUS that does not alter gastric pH is important because maintaining low gastric pH may be helpful for digestion, for gut immunity and first line defense against pathogens, for the absorption of vitamins and minerals, and for potentially additional downstream effects. As Jaguar announced in May of this year, standard drug testing in race horses that received Equilevia™ did not detect any substances commonly disallowed by horse racing authorities.
Data from the
For more information, please visit www.jaguaranimalhealth.com.
Certain statements in this press release constitute “forward-looking statements” within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934. These include statements regarding Jaguar’s expectation that a full analysis of the dose determination study data with scoring of squamous and glandular ulcers will be available this coming January, the Company’s plans to seek concurrence from CVM regarding an endpoint scoring system for Jaguar’s planned Equilevia™ pivotal field study, Jaguar’s plan to develop formulations of Equilevia™ in horses and species-specific formulations of Neonorm™ in additional target species, and Jaguar’s plan to develop formulations of Canalevia™ for cats and dogs. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
1Pellegrini FL. Results of a large-scale necroscopic study of equine colonic ulcers. J Equine Vet Sci. 2005;25(3):113-117.
GASTROGARD® is a registered trademark of Merial.
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