Jaguar Animal Health Initiates Proof-of-Concept Study to Evaluate Safety, Tolerability & Efficacy of Neonorm in Foals
Neonorm™ Foal Plus consists of a standardized botanical extract (Neonorm™) in combination with a third-party probiotic. Probiotics are live organisms that are widely used in the treatment of diarrhea in humans1, small animals2 and equines. Benefits of their use have been demonstrated in third-party human trials, and a third-party trial of probiotics in foals demonstrated increased weight gain in the treated animals3.
The objective of Jaguar’s randomized, multi-site, blind-controlled foal
study is to determine the safety, tolerability, and efficacy of Neonorm™
Foal Plus when administered orally in a paste formulation. Approximately
60 foals will be enrolled in the six-day study, each randomly assigned
to one of three different treatment groups. Fecal scoring will be
conducted every six hours during the treatment period, and twice daily
during the observation period. Exploratory outcome evaluations will also
include the use of abdominal ultrasound before and after treatment, and
between treatment groups. The initiation of the study is taking place in
“Although probiotics are commonly used in foals, there are currently no
anti-secretory products commercially available for the foal market. We
believe the combination of probiotics with the novel, anti-secretory
mechanism of action of Neonorm™ will produce a new and highly
efficacious standard of care for the management of gut health, stool
formation and the normalization of hydration in foals,” explained
Published studies estimate that there were 9.2 million horses in the
U.S. in 2005. Data from the
Neonorm™ Calf, the Company’s lead non-prescription product, contains the same standardized botanical extract as Neonorm™ Foal Plus and has been clinically demonstrated to address the normalization of stool formation and ion and water flow in the intestinal lumen of preweaned dairy calves. The Neonorm™ standardized botanical extract is derived from the Croton lechleri tree, which is sustainably harvested. Jaguar currently owns enough of this extract to formulate a combination of approximately one million treatments of Neonorm™ Calf or Neonorm™ Foal Plus.
For more information, please visit www.jaguaranimalhealth.com.
Certain statements in this press release constitute “forward-looking statements.” These include statements regarding the Company’s belief that the combination of probiotics with Neonorm™ will produce a new and highly efficacious standard of care for the management of gut health, stool formation and the normalization of hydration in foals, and the expected commercial launch of Neonorm™ Foal Plus this December. 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.
2 Marks, SL. Probiotics, prebiotics and synbiotics. What are they and when should they be implemented? Proceedings of the 34th World Small animal Veterinary congress 2009. IVIS
3 Schoster A, Weese JS, Guardabassi L. Probiotic use in horses – What is the evidence for their clinical efficacy? J Vet Int Med Vol 28 (6) 1640-1652, 2014.