Results Reported at 9th International AIDS Society (IAS)
Conference on HIV Science in Paris, France
Over 7 Million Patients with HIV Worldwide May Benefit from the
Reduction in Diarrhea Achieved with Long-Term Mytesi Therapy
SAN FRANCISCO--(BUSINESS WIRE)--Jul. 24, 2017--
Napo Pharmaceuticals, Inc., a human health company developing and
commercializing novel gastrointestinal prescription products from plants
used traditionally in rainforest areas, and Jaguar Animal Health, Inc.
(NASDAQ: JAGX) (Jaguar), announced today the results of a supplemental
analysis of the long-term trial of crofelemer (Mytesi®) in
patients with chronic HIV-related diarrhea. The analysis revealed a mean
decrease of over 70 percent in diarrhea episodes versus baseline and
over 50 percent of patients with complete resolution of their diarrhea.
The results were reported at the 9th International AIDS Society (IAS)
Conference on HIV Science on Wednesday, July 26, 2017 in Paris, France.
Mytesi (crofelemer) is the only drug that has been specifically studied
in and FDA-approved for use in managing diarrhea in people living with
HIV. The safety and efficacy of crofelemer in reducing HIV-related
diarrhea were assessed in the ADVENT trial. While the primary efficacy
and safety results have previously been reported, this supplemental
analysis was conducted to provide a more complete understanding of the
long-term efficacy of crofelemer in patients with chronic HIV-related
“Mytesi achieves much greater reductions in HIV-related diarrhea than
was apparent in the ADVENT primary responder analysis,” commented Dr.
Rodger D. MacArthur, Medical College of Georgia, Augusta, GA. “Most
patients saw meaningful reductions in diarrhea, with more than 75
percent experiencing at least a 50 percent reduction and more than half
of patients experiencing complete resolution of diarrhea at week 24. I
think it is important to note that results were consistent regardless of
use of a protease inhibitor or the cause of the diarrhea.”
Prior to study entry, patients enrolled in the ADVENT trial had an
average of 20 watery stools per week (approximately three per day). Key
results of this analysis showed:
An average reduction of 73 percent in diarrhea episodes by week 24 of
More than 75 percent of patients had a clinically meaningful reduction
in diarrhea, as measured by at least a 50 percent decrease in the
number of episodes;
More than 50 percent of patients had a complete resolution of their
diarrhea by week 24 of crofelemer treatment;
There was no significant difference between patients who were taking a
protease inhibitor and those who were not or based upon the cause of
“With an estimated 20 percent of the more than 36 million people
currently living with HIV suffering from diarrhea, there are more than
seven million patients worldwide who may benefit from the reduction in
diarrhea that can be achieved with Mytesi therapy,” said Lisa Conte,
Jaguar’s president and CEO and Napo’s interim CEO.
The poster for this data presentation is available at: http://mytesi.com/clinical-results.html
Launched by Napo Pharmaceuticals in October 2016, Mytesi is the only
antidiarrheal studied in and U.S. FDA-approved for the symptomatic
relief of noninfectious diarrhea in adults living with HIV/AIDS on
antiretroviral therapy (ART). Mytesi is a prescription treatment for
diarrhea that works differently, by acting locally in the GI tract to
normalize the flow of water. Mytesi does not have any clinically
relevant drug-drug interactions and has side effects that are similar to
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.
Crofelemer, the active ingredient in Mytesi®, is a botanical
(plant-based) drug extracted and purified from the red bark sap of the
medicinal Croton lechleri tree in the Amazon rainforest. Napo has
established a sustainable harvesting program for crofelemer to ensure a
high degree of quality and ecological integrity.
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
For more information about Jaguar, please visit www.jaguaranimalhealth.com.
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170724005611/en/
Source: Jaguar Animal Health, Inc.
KCSA Strategic Communications
Kate Tumino, 212-896-1252