SAN FRANCISCO--(BUSINESS WIRE)--Jan. 28, 2016--
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, and high-value horses, announced positive topline results today
from its proof-of-concept study to evaluate the safety and effectiveness
of its investigational new animal drug currently referred to as SB-300.
SB-300 is a pharmaceutical formulation of a standardized botanical
extract from the Croton lechleri tree, which is sustainably
harvested, for the treatment of gastrointestinal ulcers in horses.
In this prospective, blinded, randomized, negative controlled study,
Standardbred or Thoroughbred racehorses were randomized to one of three
groups (10 horses per group) and treated for 28 days: horses in the
placebo group received water-filled syringes every 6 hours; those in the
TRT5 group received 5 grams of SB-300 divided into 2 doses per day; and
those in the TRT40 group received 40 grams of SB-300 divided into 4
doses per day. Strict enrollment criteria required patients to have both
squamous (non-glandular) and glandular gastric ulcerations. All horses
were examined by gastroscopy (stomach endoscope) by blinded equine
investigators on Day 0 (prior to treatment; baseline), and on Day 14
(mid-study), Day 28 (last day of treatment) and Day 35 (7 days after
last treatment). Treatment-related adverse events were not observed.
With respect to glandular ulcerations, a statistically significantly
greater number of horses in both the TRT40 (89%) and the TRT5 (78%)
group had an improvement or a resolution of glandular ulcerations,
compared with the placebo (25%) group as soon as Day 14. By Day 35, all
of the SB-300 treated horses had experienced improvement or resolution,
whereas 25% of horses in the placebo group still had not improved or
resolved during the study.
With respect to squamous ulcerations, a non-statistically significant
dose-dependent effect was observed with 40% and 33% of horses achieving
an improvement or a resolution by Day 14 in the TRT40 and TRT5 groups,
respectively, compared with 11% of placebo horses. By Day 35,
numerically more horses in the TRT40 (60%) and TRT5 (55%) groups had
achieved an improvement or a resolution compared with 33% of placebo
horses.
Jaguar will be releasing additional findings from this study after
further analysis of the data.
As Jaguar stated on November 5th of last year in a press
release announcing the initiation of this study, stall confinement,
stress, intermittent feeding, intense exercise and administration of
non-steroidal anti-inflammatories are factors that may lead to gastric
ulcers in horses1 and, frequently, in performance equine
athletes. Horses with gastric ulcers may perform poorly, which makes
this condition an economic as well as health problem within the horse
industry2.
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.3
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.
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 diarrhea in dogs. 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™ 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, and formulations of Canalevia™ for
cats, horses and dogs.
For more information, please visit www.jaguaranimalhealth.com.
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking
statements.” These include statements regarding Jaguar’s plans to
develop an FDA-approved, first-in-class complete ulcer and gut treatment
for horses, the Company’s plan to release additional findings from its
recently completed proof-of-concept study, 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.
1Habershon-Butcher, J.L., Hallowell, G.D., Bowen, I.M.,
Sykes, B., 2012. Prevalence and risk factors for ulceration of the
gastric glandular mucosa in thoroughbred race horses in training in the
U.K and Australia. J. Vet. Intern. Med. 26, 731.
2Vatistas, N.J., Synder, J.R., Carlson, G., Johnson, B.,
Arthur, R.M., Thurmond, M., Zhou, H. and Lloyd, K.L.K. (1999) Cross-sectional
study of gastric ulcers of the squamous mucosa in thoroughbred racehorses.
Equine Vet. J. 31.
3Pellegrini FL (2005). Results of a large-scale
necroscopic study of equine colonic ulcers. J Equine Vet Sci; 25
(3): pp. 113-117.
Jaguar-JAGX
View source version on businesswire.com: http://www.businesswire.com/news/home/20160128005812/en/
Source: Jaguar Animal Health, Inc.
KCSA Strategic Communications
Garth Russell, 212-896-1250
grussell@kcsa.com
or
Allison
Soss, 212-896-1267
asoss@kcsa.com
