SAN FRANCISCO–(BUSINESS WIRE)–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, announced today the results of a recently completed field study
conducted in Wisconsin. The Company believes the results further support
the beneficial effects of Neonorm™ Calf, Jaguar’s lead
non-prescription product, in reducing water loss associated with
diarrhea and supporting weight gain in preweaned dairy calves.
The objectives of the double blind, randomized, placebo-controlled field
study, which involved 200 preweaned dairy calves, were to evaluate the
efficacy of Neonorm™ Calf on the normalization of stool
formation in the animals and evaluate the effect of treatment on
pre-wean weight gain in a real-life dairy farm setting. All
participating calves received an enteric-coated bolus or a placebo,
twice a day for three days. The fecal consistency of participating
calves was scored on a daily basis using the Calf Health Scoring
criteria for fecal consistency from the University of Wisconsin.
On average, during the three-day treatment period, each calf with a
watery stool that received Neonorm™ Calf treatment gained
approximately 2.2 kilograms more than placebo-treated pre-weaned calves
with the same fecal score, while the pre-wean weight gain for all
participating treated calves was 0.45 kilograms more than for the full
group of placebo-treated animals. Pre-wean weight influences lifetime
productivity for dairy cattle, as preweaning nutrition has a significant
effect on mammary gland development, the timing of puberty, and the age
at which dairy cows first produce milk.
Following day one of treatment, 27.3% of treated calves achieved
normalized stool formation, versus 19.4% of placebo-treated calves.
Following day two of treatment, 63.6% of treated calves achieved
normalized stool formation, versus 60.2% of placebo-treated calves, and,
following day three of treatment, 85.9% of treated calves achieved
normalized stool formation, versus 83.7% of placebo-treated calves. Each
of the results achieved borderline statistical significance.
“We believe this study indicates the beneficial effect of Neonorm™
Calf, in real-world conditions involving animals that were
simultaneously being provided with an array of probiotics, antibiotics,
and other medicines by their handlers as part of their normal standard
of care. Given this ‘uncontrolled’ aspect of the study, we are pleased
to see the additive benefit of the new mechanistic approach of Neonorm™
Calf, which increases the percentage of responding calves with each day
of treatment and continues to display an associated beneficial effect
that supports weight gain,” stated Lisa Conte, Jaguar’s president and
CEO. “We believe this study further demonstrates the potential for
Neonorm™ Calf to be a novel, first-in-class product that
provides health and economic benefits to the dairy industry beyond the
current standards of care.”
As the Company announced last month, a field study conducted by
researchers from Cornell University College of Veterinary Medicine
(“Cornell”) to evaluate the effect of Neonorm™ Calf in
preweaned dairy calves was recently published in the official journal of
the American Dairy Science Association, Journal of Dairy Science.
The Cornell study also displayed a beneficial effect of Neonorm™
Calf in supporting weight gain in calves. These findings served as the
catalyst for the Company to investigate the potential prebiotic
mechanism of Neonorm™ Calf. This research is currently
ongoing at Cornell.
Neonorm™ Calf contains the same standardized botanical
extract as Neonorm™ Foal Plus, an equine product that Jaguar
expects to launch this December. 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.
About Neonorm™ Calf
Neonorm™ Calf is an enteric-coated tablet designed to be
orally administered to preweaned dairy calves twice daily for three
days. It has been formulated and clinically tested to specifically
address the normalization of stool formation and ion and water flow in
the intestinal lumen of newborn dairy calves. The product acts locally
in the gut and is minimally absorbed systemically. It does not alter
gastrointestinal motility, and, to date, has shown no significant
effects on normally functioning intestinal ion channels and electrolyte
or fluid transport, nor shown any side effects different from placebo.
As a result, stool formation is normalized in a short period of time,
weight loss is mitigated, and supportive care costs and rehydration
therapies such as oral rehydration solution, or ORS, are reduced. Neonorm™
Calf has not been evaluated by the FDA for use in animals.
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. Canalevia™ is Jaguar’s
lead prescription drug product candidate for the treatment of various
forms of watery diarrhea in dogs. Neonorm™ Calf is the
Company’s lead non-prescription product. Canalevia™ is a
canine-specific formulation of crofelemer, an active pharmaceutical
ingredient isolated and purified from the Croton lechleri tree,
which is sustainably harvested. 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
filed nine Investigational New Animal Drug applications, or INADs, with
the U.S. FDA and intends to develop species-specific formulations of
Neonorm™ in six additional target species, and formulations
of Canalevia™ for cats, horses and dogs.
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 results of the field study in Wisconsin further support the
beneficial effects of Neonorm™ Calf in reducing water loss
associated with diarrhea and supporting weight gain in preweaned dairy
calves, the potential for Neonorm™ Calf to be a novel,
first-in-class product that provides health and economic benefits to the
dairy industry, Jaguar’s expected commercial launch of Neonorm™
Foal Plus this December, and the Company’s intention to develop
species-specific formulations of Neonorm™ in six additional
target species, and formulations of Canalevia™ for cats,
horses 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.
KCSA Strategic Communications
Garth Russell, 212-896-1250