Statistically Significant Final Results
Confirm Interim Conclusion That Crofelemer Treatment is Superior to
Placebo
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, announced final
topline results today for the multicenter proof-of-concept study
the Company conducted in 2015 to evaluate the safety and efficacy
of crofelemer, the active pharmaceutical ingredient in Jaguar’s
Canalevia™ prescription drug product candidate, for treatment of
secretory, or watery, diarrhea in dogs.
Crofelemer is isolated and purified from Croton lechleri, a tree
that is sustainably harvested and contains anti-secretory
properties. Crofelemer has demonstrated efficacy in numerous human
clinical trials of acute watery diarrhea induced by various
infectious pathogens. A human-specific formulation of crofelemer
was approved by the U.S. Food and Drug Administration in 2012 for
the symptomatic relief of noninfectious diarrhea in adults with
HIV/AIDS on antiretroviral therapy, often a chronic problem, and
was launched commercially by Napo Pharmaceuticals, Inc. last week
under the tradename Mytesi™.
The crofelemer proof-of-concept study was comprised of two
stages. Stage 1 was a randomized, double-blind, placebo-controlled
stage to assess the efficacy of crofelemer administered orally in
alleviating clinical signs associated with secretory diarrhea in
dogs, and to assess the safety of the product candidate. Stage 2 of
the study was an open-label continuation of the safety assessment
of crofelemer for the same indication and was not
placebo-controlled. During Stage 1, 61 dogs were evaluated, and 53
dogs were evaluated during Stage 2.
During Stage 1, dogs exhibiting a fecal score of 4 (watery,
liquid stool) or 5 (severe watery diarrhea) on a scale of 1 to 6
were randomized to receive either an enteric-coated crofelemer
formulation, or a matching enteric-coated placebo formulation,
administered twice a day for 72 hours, in addition to receiving
standard of care therapy. Stool consistency and frequency were
assessed at multiple time periods daily during the in-life portion
of the study, which consisted of a 72-hour treatment period,
followed by an observation period.
On February 19, 2015, Jaguar announced the results of an interim
analysis of data from Stage 1 of the study. The interim analysis
was based on 39 dogs with secretory diarrhea that took part in the
study up to February 12, 2015. The statistically significant
results for the 39-dog group showed crofelemer treatment to be
superior to placebo in a resolution analysis of diarrhea, measured
as a percentage of crofelemer-treated dogs (91.0%) that achieved
formed stools (a fecal score of 1 or 2) during the evaluation
period versus placebo-treated animals (50.0%), with a p-value of
0.007.
From February 12, 2015 to February 19, 2015, an additional 22
dogs with secretory diarrhea were enrolled in Stage 1 of the study.
The results for the combined group of 61 Stage 1 dogs were also
statistically significant, showing crofelemer treatment to be
superior to placebo in the resolution of diarrhea, measured as a
percentage of crofelemer-treated dogs (93.1%) that achieved formed
stools (a fecal score of 1 or 2) during the evaluation period
versus placebo-treated animals (68.8%), with a p-value of
0.0237.
Jaguar is in the midst of a final pivotal field study to
evaluate the safety and efficacy of Canalevia™ for treatment of
acute diarrhea in dogs. An estimated 200 dogs will be enrolled in
the Canalevia™ pivotal study, which is expected to complete
enrollment around the end of 2016.
“We’re very pleased that the results for the additional 22 dogs
enrolled in Stage 1 of the proof-of-concept study support the
conclusion that crofelemer has the potential to serve as an
effective new tool in the treatment of canine secretory diarrhea,
and that these data are consistent with the power calculations for
our ongoing field study to support approval of Canalevia™ for acute
diarrhea,” stated Lisa Conte, Jaguar’s president and CEO. “We
estimate that U.S. veterinarians see approximately six million
annual cases of acute and chronic watery diarrhea in dogs.
Devastating dehydration can occur rapidly for the animal, and the
lack of control in urban settings where owners don’t have easy
access to outdoor facilities is a real problem for dog-owning
families.”
As the Company announced on April 13, 2016, it has obtained
protocol concurrence from the Center for Veterinary Medicine
(“CVM”) of the U.S. Food and Drug Administration for the Canalevia™
pivotal field study. Protocol concurrence for the pivotal study was
achieved following a discussion with CVM of the clinical relevance
of the results of the interim analysis Jaguar conducted on the
initial 39 dogs enrolled in Stage 1 of the crofelemer
proof-of-concept study.
“Following discussions with CVM regarding the clinical relevance
of the proof-of-concept study and discussions about our clinical
trial rigor in the ongoing field trial, which involves collecting
data during the 72-hour treatment period with a 24-hour observation
period, Jaguar and CVM agreed that the pivotal study protocol for
Canalevia™ would define a responder as a dog that does not exhibit
watery stool for a 16-hour window during the 72-hour study period
or during the following 24-hour observation period,” explained Dr.
Michael Guy, a Jaguar vice president and clinical veterinarian.
Jaguar expects to file the new animal drug application (“NADA”)
for Canalevia™ in 2017 for the indication of acute diarrhea in dogs
and to conduct the commercial launch of the product, if it is
approved. Jaguar has also established an investigational new animal
drug (INAD) file for Canalevia™ for chemotherapy-induced diarrhea
(“CID”) in dogs, for which it has received MUMS designation.
Diarrhea is one of the most common reasons for veterinary office
visits for dogs and is the second most common reason for visits to
the veterinary emergency room, yet there are currently no
FDA-approved anti-secretory agents to treat acute diarrhea in dogs.
According to the American Veterinary Medical Association, there
were approximately 70 million dogs in the United States in
2012.
About Canalevia™
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 Croton
lechleri, a tree that is sustainably harvested and contains
anti-secretory properties. The product is an oral, enteric-coated,
twice daily formulation of crofelemer that acts locally in the
gastrointestinal tract. It acts at the last physiological step,
conserved across mammalian species, in the manifestation of acute
diarrhea.
About Mytesi™
Mytesi™ (crofelemer) is an antidiarrheal indicated for the
symptomatic relief of noninfectious diarrhea in adult patients with
HIV/AIDS on antiretroviral therapy (ART). Mytesi™ is not indicated
for the treatment of infectious diarrhea. Rule out infectious
etiologies of diarrhea before starting Mytesi™. If infectious
etiologies are not considered, there is a risk that patients with
infectious etiologies will not receive the appropriate therapy and
their disease may worsen. In clinical studies, the most common
adverse reactions occurring at a rate greater than placebo were
upper respiratory tract infection (5.7%), bronchitis (3.9%), cough
(3.5%), flatulence (3.1%), and increased bilirubin (3.1%).
More information and complete Prescribing Information are
available at Mytesi.com.
About Napo Pharmaceuticals, Inc.
San Francisco-based Napo Pharmaceuticals, Inc., focuses on the
development and commercialization of proprietary pharmaceuticals
from rainforest resources for the global marketplace in
collaboration with local partners. Recently, Napo and Jaguar Animal
Health, Inc. (NASDAQ: JAGX), an animal health company focused on
developing and commercializing first-in-class gastrointestinal
products for companion and production animals, foals, and high
value horses, announced plans for a proposed merger of the two
companies.
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, please visit
www.jaguaranimalhealth.com.
Forward-Looking Statements
Certain statements in this press release constitute
“forward-looking statements” within the meaning of section 27A of
the Securities Act of 1933 and section 21E of the Securities
Exchange Act of 1934. These include statements regarding the
expected completion of enrollment around the end of 2016 for
Jaguar’s pivotal study for Canalevia™, the estimate that 200 dogs
will be enrolled in the Canalevia™ pivotal study, the Company’s
plans to file the new animal drug application (“NADA”) for
Canalevia™ for the indication of acute diarrhea in dogs in 2017,
Jaguar’s plan to conduct the commercial launch of Canalevia™ for
the indication of acute diarrhea in dogs, if the product is
approved, Jaguar’s plan to develop formulations of Equilevia™ in
horses and species-specific formulations of Neonorm™ in additional
target species, and Jaguar’s plan to develop formulations of
Canalevia™ for cats 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
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version on businesswire.com: http://www.businesswire.com/news/home/20161018005592/en/
KCSA Strategic CommunicationsGarth Russell,
212-896-1250grussell@kcsa.com
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