Advantages as an Alternative Approach to the Management of
Gastrointestinal Ulcers in Horses
SAN FRANCISCO--(BUSINESS WIRE)--Feb. 16, 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 horses, released additional findings today from its
recently completed 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 Equine Gastric Ulcer
Syndrome (EGUS).
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.
The press release Jaguar issued on January 28, 2016 announced positive
topline results from the study. Further analysis of the study results
indicates that SB-300 did not alter gastric pH during the 28-day trial,
or for 7 days after therapy. Gastric pH during therapy was observed to
be similar to baseline gastric pH at all measured study time points.
“Whereas other ulcer treatments (e.g. proton pump inhibitors like
omeprazole) rely on a mechanism of action that blocks gastric acid
secretion for the treatment and prevention of EGUS, our preliminary data
indicate that SB-300 may have advantages,” stated Lisa Conte, Jaguar’s
president and CEO. “Treatments for EGUS that do not alter gastric pH are
important because maintaining low gastric pH is essential for digestion,
for gut immunity and first line defense against pathogens, for the
absorption of vitamins and minerals, and for potentially other
downstream effects.”
As Jaguar announced on January 28th, 2016, the results of the Company’s
study indicate that 78 to 89% of horses treated with SB-300 (depending
on dose) had resolution or improvement of glandular ulcers as soon as 14
days during treatment. Published studies1,2 with omeprazole
have demonstrated that between 14 and 34% of horses diagnosed with EGUS
are observed with resolution or improvement of glandular ulcers when
used at the manufacturer’s recommended treatment duration of 28 days.
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.
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 Stall
confinement, stress, intermittent feeding, an overreliance on grain in
place of grazing, intense exercise, and administration of non-steroidal
anti-inflammatories are factors that may lead to gastric ulcers in
horses.4 “Ulcers are lesions that may be manifested both
clinically and subclinically, significantly compromising both health and
athletic performance in horses,” stated equine veterinarian members of
Jaguar’s clinical operations team.
SB-300 may offer horse owners an additional advantage over omeprazole in
the competition horse world, where the requirement exists for equine
athletes to compete free from the effect of any drugs. International
screening limits for horse racing state that omeprazole has a 72-hour
detection time. Detection time is defined as the first observed time
point at which urine and/or plasma samples collected from a horse are
negative for the presence of a specified drug. “Because SB-300 acts
locally in the gut and is minimally absorbed, it is unlikely that use of
this drug product candidate will present any issues related to detection
time,” explained Conte. “We intend to demonstrate that SB-300 is not
systemically absorbed in horses, thereby providing a treatment regimen
that can continue without mandatory withdrawal prior to competition.
Moreover, we also aim to demonstrate that SB-300 can be administered in
the presence of feed, another constraint of omeprazole administration.”
Following the late stage development toward anticipated FDA approval of
SB-300, Jaguar plans to focus initial promotional efforts on the segment
of the equine market that is most likely to seek treatment for EGUS:
owners and caregivers of high-value horses, equine athletes, and horses
that are insured. According to the American Veterinary Medical
Association, an estimated 9% of horse owners in the U.S. have insurance
for the animals. “It is clear that development of a natural alternative
treatment for EGUS that maintains stomach health without altering
stomach pH is desirable,” Conte said. “We plan to initiate further
studies to differentiate the benefits that we believe SB-300 will offer
to equine athletes challenged with glandular ulcers, and our goal is to
see SB-300 serve as an important tool in the standard of care.”
The U.S. patent for use of omeprazole to treat equine ulcers expired in
2015.
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, 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.
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 belief that SB-300 may offer horse owners an
additional advantage over omeprazole in the competition horse world,
Jaguar’s intention to demonstrate that SB-300 is not systemically
absorbed in horses and can be administered in the presence of feed,
Jaguar’s plans to focus initial promotional efforts on the segment of
the equine market that is most likely to seek treatment for EGUS, the
Company’s plan to initiate further studies to differentiate the benefits
it believes SB-300 will offer, Jaguar’s goal to see SB-300 serve as the
new standard of care, 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.
1Sykes BW, Sykes KM, Hallowell GD. A comparison of three
doses of omeprazole in the treatment of equine gastric ulcer syndrome: A
blinded, randomised, dose-response clinical trial. Equine Vet J.
2015;47(3):285-290.
2Sykes BW, Sykes KM, Hallowell GD. A comparison of two doses
of omeprazole in the treatment of equine gastric ulcer syndrome: a
blinded, randomised, clinical trial. Equine Vet J.
2014;46(4):416-421.
3Pellegrini FL. Results of a large-scale necroscopic study of
equine colonic ulcers. J Equine Vet Sci. 2005;25(3):113-117.
4Habershon-Butcher JL, Hallowell GD, Bowen IM, Sykes BW.
Prevalence and risk factors for ulceration of the gastric glandular
mucosa in thoroughbred race horses in training in the UK and Australia.
J Vet Intern Med. 2012;26:731.
Jaguar-JAGX
View source version on businesswire.com: http://www.businesswire.com/news/home/20160216005997/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
