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, and Napo
Pharmaceuticals, Inc. (Napo), which focuses on the development and
commercialization of proprietary gastrointestinal pharmaceuticals
for the global marketplace from sustainably derived plants used
traditionally in rainforest areas, today announced that an
Argentina-based study titled “Safety and efficacy of a combined
paste formulation of Neonorm™ Foal, a botanical extract of the
latex of Croton lechleri, and probiotics for the treatment of
watery diarrhea in nursing foals” has been accepted for publication
by Analecta Veterinaria, a bi-annual, peer-reviewed publication of
the Faculty of Veterinary Sciences of the National University of La
Plata in Argentina.
Neonorm™ Foal, one of Jaguar’s lead non-prescription products,
is a non-drug anti-diarrheal for newborn horses in
orally-administered paste form. Dr. Siobhan McAuliffe, MVB, DACVIM,
served as the primary investigator of the randomized, multi-site,
blind-controlled study, which took place in 2015 in Argentina
during the southern hemisphere’s foaling season.
The study objective was to evaluate the safety, tolerability,
and efficacy of Neonorm™ Foal for treatment of foals suffering from
secretory or watery diarrhea. Sixty foals participated in the
study, which consisted of a 72-hour treatment period followed by an
observation period. The treated animals received Neonorm™ Foal in
combination with a third-party probiotic.
Each participating foal was placed into one of three groups: a
group that received treatment twice a day (the BID group), a group
that received treatment four times a day (the QID group), and a
placebo-treated group. Physicals, ultrasounds and the collection of
blood samples took place at intervals throughout the study. Fecal
scoring was conducted in conjunction with the dosing times during
the treatment period and followed by twice daily thereafter until
the end of the observation period.
The percentage of responders from 0-72 hours was greater in the
IVP BID group (68%) than in the placebo group (35%) with a p value
of 0.03. The percentage of responders from 0-96 hours was also
found to be greater in IVP BID group (79%) when compared to the
placebo group (47%) with a p value of 0.03. From 0-120 hours, the
percentage of responders in the IVP QID group was 84% versus 53% in
the placebo group, which was found to be significant with a p value
of 0.04.
For the subset of foals with a baseline fecal score of 4
(indicating severe watery diarrhea with no particulate matter
visible or no diarrhea seen but watery staining of the tail,
perineum or walls evident), the percentage of responders from 0-96
hours was found to be significantly different (p = 0.02) between
the IVP BID (85%) and placebo (39%) groups. For the interval from
0-120 hours, the IVP QID group (94%) was found to be significantly
different (p = 0.02) from the placebo group (46%).
“We’re thrilled that this study has been accepted for
publication by Analecta Veterinaria. Jaguar’s Neonorm™ and
crofelemer products, which are both derived from the sustainably
harvested Croton lechleri tree, act at the same last step in a
physiological pathway generally present in mammals. Clinical
research investigating this unique Mechanism of Action have
provided efficacy results with significance in people, calves and
dogs in addition to horses. The Neonorm™ Foal study results support
our belief that the first-in-class anti-secretory properties of
Neonorm™ will redefine the standard of care for management of
diarrhea, gut health, and the normalization of hydration in foals
and underscores our ongoing commitment to total equine gut health,”
stated Lisa Conte, Jaguar's president and CEO and Napo’s interim
CEO.
Dr. McAuliffe commented, “Word spread very quickly in Argentina
as to how well Neonorm™ Foal was working. This meant we had very
rapid enrollment in the study during breeding season, with owners
and farm managers desperate to participate.”
Diarrhea is one of the most common clinical complaints in foals,
especially within the first 30 days of life, and to Jaguar’s
knowledge there are currently no commercially available products
with anti-secretory properties for foals. The crippling effects of
dehydration that often occur as a result of secretory diarrhea in
foals can manifest quickly, precipitate adverse health effects and
result in death.
Proposed Merger
As announced March 31, 2017, Napo and Jaguar Animal Health, Inc.
have entered a definitive merger agreement. The proposed merger of
Jaguar and Napo remains subject to customary conditions to closing.
Upon the consummation of the merger, Jaguar’s name will be changed
to Jaguar Health, Inc., and Napo will operate as a wholly-owned
subsidiary of Jaguar, focused on human health. Jaguar and Napo are
holding their respective stockholder meetings to approve the merger
on July 27, 2017.
About Napo Pharmaceuticals, Inc.
San Francisco-based Napo Pharmaceuticals, Inc. focuses on the
development and commercialization of proprietary gastrointestinal
pharmaceuticals for the global marketplace from sustainably derived
plants used traditionally in rainforest areas.
For more information, please visit www.napopharma.com.
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.
For more information about Jaguar, please visit
www.jaguaranimalhealth.com.
Forward-Looking Statements
Certain statements in this press release constitute
“forward-looking statements.” These include statements regarding
the proposed merger between Jaguar and Napo, Jaguar’s intention to
develop species-specific formulations of Neonorm™ in additional
target species, and the Company’s plan to develop 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.
Jaguar-JAGX
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170718005750/en/
KCSA Strategic CommunicationsGarth Russell,
212-896-1250grussell@kcsa.com
Jaguar Health (NASDAQ:JAGX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Jaguar Health (NASDAQ:JAGX)
Historical Stock Chart
From Apr 2023 to Apr 2024