Jaguar Enters Exclusive Evaluation Period With Multinational Animal Health Pharmaceutical Firm Regarding Equilevia, Jaguar’s Drug Product Candidate for Equine Gastric Ulcer Syndrome

Jaguar Animal Health, Inc. (NASDAQ: JAGX) (Jaguar), an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals, foals, and high value horses, announced today that it has entered an exclusive, 60-day evaluation period, commencing April 3, 2017, with a leading multinational animal health pharmaceutical firm regarding Equilevia (formerly referred to as SB-300), Jaguar’s drug product candidate for Equine Gastric Ulcer Syndrome (EGUS). Equilevia is a pharmaceutical formulation of a standardized botanical extract.

Jaguar completed a dose determination study of the target commercial paste formulation of Equilevia in the fourth quarter of last year. The equine veterinarians who performed the study were blinded to the treatment assignment, and Jaguar was also blinded to the data at that time. A full analysis of the study data with scoring of squamous and glandular ulcers has undergone independent, blinded review by Dr. Frank Andrews, DVM, MS, Dipl. ACVIM, Professor and Director of the Equine Health Studies Program at Louisiana State University College of Veterinary Medicine, an equine internist specializing in gastric ulcer disease. All data from the dose determination study will remain confidential during the 60-day evaluation period.

The third-party review Dr. Andrews conducted of the study data involved viewing gastroscopy videos for all participating horses and evaluating each horse against three separate EGUS grading scales: the McAllister scoring system (which assesses the number and severity of ulcers), the EGUS Council scoring system (which is relevant only for squamous ulcers), and a new visual analog scoring system, relevant for both squamous and glandular ulcers, developed by Dr. Andrews.

“This study showed consistency in the evaluation of gastric ulcers by the newly developed visual analog scoring system compared to the published McAllister and EGUS Council grading scales,” stated Dr. Andrews. “The visual analog scoring system could be an important tool in providing greater precision in gastric ulcers of differing tissue type, such as glandular lesions.”

As Jaguar announced in January 2016, topline results from the Company’s 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. The proof-of-concept study evaluated a dose of 10 grams of Equilevia given orally four times daily (total daily dose of 40 g) and five grams of Equilevia given twice daily (total daily dose of 10 g). The horses studied were in training but were not actively racing.

As Jaguar announced in February 2016, further analysis of the results of the proof-of-concept study indicates that Equileviadid not alter gastric pH during the 28-day trial or for seven 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 2016, standard drug testing in race horses that received Equilevia did not detect any substances commonly disallowed by horse racing authorities.

In November 2016 Jaguar issued a summary of racing data for horses taking part in the Company’s Equilevia dose determination study. Racing results in horses treated with Equilevia are of interest because ulcers are a particular problem in equine athletes. In races during the study treatment period, horses on treatment with Equilevia had higher average winnings, higher average total dollar winnings, and a higher likelihood of finishing a race in the top 3 or in the top 5, compared with the period in which they raced prior to the study.

Data from the American Horse Council states that there are currently 9.2 million horses in the U.S., a population that includes 844,531 race horses, more than 2.7 million show horses, and more than 3.9 million recreational horses. Data from the Food and Agriculture Organization of the United Nations indicate that there were approximately 5.7 million horses in Europe in 2013 and nearly 60 million horses in 2013 worldwide. 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.1

“The partnering strategy of both Jaguar and Napo is focused on bringing novel gastrointestinal medicines from the two company’s extremely broad pipelines to market in a productive and efficient manner, and entering a possible collaboration with a leading animal health company focused on equine athletes would be an important component of this strategy,” commented Lisa Conte, Jaguar’s president and CEO and Napo’s interim CEO.

About Jaguar Animal Health, Inc.

Jaguar Animal Health, Inc. is an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals, foals, and high value horses. Canalevia is Jaguar’s lead prescription drug product candidate, intended for the treatment of various forms of diarrhea in dogs. Equilevia (formerly referred to as SB-300) is Jaguar’s prescription drug product candidate for the treatment of gastrointestinal ulcers in horses. Canalevia and Equilevia contain ingredients isolated and purified from the Croton lechleri tree, which is sustainably harvested. Neonorm Calf and Neonorm Foal are the Company’s lead non-prescription products. Neonorm is a standardized botanical extract derived from the Croton lechleri tree. Canalevia and Neonorm are distinct products that act at the same last step in a physiological pathway generally present in mammals. Jaguar has nine active investigational new animal drug applications, or INADs, filed with the FDA and intends to develop species-specific formulations of Neonorm in six additional target species, formulations of Equilevia in horses, and Canalevia for cats and dogs.

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