Jaguar Animal Health, Inc. (NASDAQ: JAGX) ("Jaguar" or the "Company"), 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 additional topline results today from its study conducted in conjunction with researchers from Cornell University College of Veterinary Medicine ("Cornell") to evaluate the efficacy of the prophylactic use of a second-generation, powder formulation of Neonorm Calf, administered in liquid, on naturally occurring diarrhea and dehydration in preweaned dairy calves.
Neonorm Calf, one of Jaguar's lead non-prescription products, has been formulated and clinically tested to help proactively retain fluid in dairy calves and reduce the severity of diarrhea-aiding the animals in avoiding debilitating, dangerous levels of dehydration associated with scours. The powder form of the product allows for ease of administration for entire herd management.
This double-blind, randomized study involved 40 newborn Holstein bull calves and compared the prophylactic use of Neonorm against a placebo. Treatment administration was performed twice daily for 14 days starting on the first feeding after colostrum administration. The calves were kept for an additional 10 days after the final treatment administration for clinical observation and sample collection. Calves were housed in individual pens and feeding was restricted to saleable whole milk. Data regarding fecal dry matter were used to measure water loss due to secretory diarrhea.
The study results show that calves under prophylactic administration of Neonorm had significantly lower water content in fecal samples at multiple measurement points, lower incidence of diarrhea, and had fewer fluid therapy interventions.
Fecal scoring, which was conducted daily during the study period, indicated a significantly lower incidence of diarrhea among Neonorm-treated calves on most treatment days than among calves in the placebo group. The study also assessed the incidence of diarrhea from days 1 to 25 of life. Calves in the Neonorm-treated group experienced a highly significant reduction in the incidence of diarrhea during this period compared to those in the placebo group.
Dehydration was assessed twice daily for all calves in the study. Results showed that severe dehydration requiring the administration of intravenous ("IV") fluid therapy was reduced by approximately 50% in the Neonorm-treated calves. Moreover, overall rescue therapy, requiring either oral or IV fluid administration, for both severe and moderate dehydration, was significantly reduced in the Neonorm-treated animals.
The study results complement the results of a prior study, also conducted by Jaguar in association with Cornell, that evaluated the effect of Neonorm on diarrhea severity and consistency in newborn Holstein bull calves experiencing diarrhea induced by enterotoxigenic Escherichia coli (E. coli). The results of this earlier study were published in the official journal of the American Dairy Science Association, Journal of Dairy Science, in 2015, and the Cornell team hopes to publish the full results of the recently-completed study as well.
"The results appear to support the potential prophylactic benefits of an easy-to-administer powder formulation of Neonorm on reducing the incidence and severity of diarrhea and associated fluid loss, herd-wide, in calves," commented Dr. Andre Gustavo Teixeira of Cornell, the principal investigator of the recently completed study.
Lisa Conte, Jaguar's president and CEO, stated, "We are quite pleased by the additional findings from this study. The positive prophylactic effect of the powder formulation of Neonorm in calves supports and underscores the prophylaxis data generated by the recently completed piglet studies of the powder formulation of Neonorm conducted in China by Chinese investigators. As the most common disease in newborn pigs*, diarrhea has a significant impact on the global swine market as well as food security."
As Jaguar announced this past July, the Company has entered into negotiations for a potential exclusive distribution relationship for Neonorm for dairy cattle and pigs in the Chinese marketplace with the China-based business entity that was involved in conducting the piglet studies.
Neonorm is a standardized botanical extract derived from the Croton lechleri tree, which is sustainably harvested. Neonorm Calf and Neonorm Foal are the Company's lead non-prescription products. Jaguar intends to develop species-specific formulations of Neonorm in six additional target species.
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. SB-300 is Jaguar's prescription drug product candidate for the treatment of gastrointestinal ulcers in horses. Canalevia and SB-300 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 SB-300 in horses, and Canalevia for cats and dogs.
For more information, please visit www.jaguaranimalhealth.com.