Full Press Release Details
Jaguar Health Reports Phase 3 OnTarget Trial
Cancer Supportive Care Drug Crofelemer
Initial results of unprecedented trial including
10 different tumor types indicate that OnTarget did not meet its primary endpoint across all tumor types.
Trial did reveal clinically relevant signals for crofelemer in prespecified subgroups of patients with breast and respiratory cancer,
including lung cancer.
to host investor webcast Tuesday, July 23rd at 8:30 AM Eastern to provide updates on
company's cancer supportive care portfolio, including participation from Jaguar scientific team, patient advocates, and
leading oncology experts on cancer therapy-related diarrhea (CTD) and oral mucositis; Click here
to register for webcast.
SAN FRANCISCO, CA / ACCESSWIRE /
July 23, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced the results
from its initial analysis of the pivotal Phase 3 OnTarget trial of crofelemer for prophylaxis
of diarrhea in adult cancer patients with solid tumors receiving targeted therapy with or without standard chemotherapy. Crofelemer is
an FDA-approved prescription drug for the symptomatic relief of diarrhea in adult HIV/AIDS patients receiving antiretroviral therapy.
The initial results from the OnTarget study show that the multicenter, double-blind, placebo-controlled pivotal clinical trial did not
meet its primary endpoint for the prespecified analysis of all tumor types in the trial.
"While the results of the OnTarget study did not achieve significance
for all tumor types receiving various targeted therapies, I am pleased that the subgroup analyses show that crofelemer provides clinically
meaningful improvement in the prespecified subgroups of breast and respiratory tumor patients. Clinical meaningfulness of these results
is based on the information provided by solid tumor patients from a survey that informed us about the appropriate clinical study design
and clinical endpoints, that are important to the patients in this prophylactic trial. We will continue to evaluate important OnTarget
findings, with further analyses," said Pablo Okhuysen, MD, Professor of Medicine, University of Texas MD Anderson Cancer Center,
Houston, Texas, who is the Principal Investigator of the OnTarget clinical trial. "It is important to note that the prespecified
secondary outcomes for this study were based on outcomes that were considered to be meaningful by patients experiencing diarrhea due to
KEY TAKE-A-WAYS FROM ONTARGET TRIAL
The unprecedented OnTarget trial included patients with 10 different
tumor types and 24 different targeted agents, with and without multiple standard cytotoxic chemotherapies. It consisted of two 12-week
stages: a 12-week double-blind treatment phase followed by a 12-week double-blind extension phase. The prespecified primary endpoint for
the trial was defined as reducing the average number of weekly loose and/or watery stools for all tumor types receiving various targeted
therapies over the initial 12-week period of this prophylactic study. Analysis of data for the initial 12-week stage revealed clinically
relevant signals for crofelemer over placebo in the prespecified subgroups of breast and respiratory cancer patients, who comprised over
75% of the patients in OnTarget, and it appears that this benefit improved over the initial 12-week stage. The data for the study's
12-week extension phase has not yet been analyzed. The company will complete the analysis of full data for the first and second 12-week
periods and will disclose the results in future presentations and publications.
"We believe the OnTarget trial, designed boldly to address a
broad array of cancer patients undergoing therapy known to be associated with diarrhea, did not meet the primary endpoint given the heterogenous
nature of the patients enrolled in the trial. Nevertheless, we are pleased that our preliminary analysis of the study data shows a clinically
meaningful benefit in response to crofelemer in patients with breast and respiratory cancers, including lung cancer," said Lisa
Conte, Founder, President, and Chief Executive Officer of Jaguar. "Breast and lung cancer are two of the top three most common cancer
types, and treatment options for breast and lung cancer include the long-term use of targeted therapies that cause high incidences of
diarrhea. We will continue to review data from prespecified and non-prespecified OnTarget subgroups and then engage in discussions with
the U.S. Food and Drug Administration (FDA) to seek the most efficient pathway to bring crofelemer to these patients and address the important
and debilitating side effect of cancer therapy-related diarrhea with the paradigm shifting mechanism of crofelemer. Patient dignity and
the ability of patients to adhere with comfort to their cancer therapy is first and foremost in our ongoing development efforts."
Crofelemer was well tolerated in OnTarget, and the adverse event profile
was similar to placebo. Most adverse events were related to the cancer therapy and/or the disease itself. The OnTarget findings are based
on 287 patients representing all solid tumor types and 24 targeted agents, with or without cytotoxic chemotherapy. Included within the
287 enrolled patients were 37 respiratory cancer patients and 180 breast cancer patients or greater than 75%. The patients were enrolled
from 49 sites and included investigators from oncology clinics in the United States, Argentina, Georgia, Serbia, and Taiwan.
"Our deepest gratitude goes to the patients and investigators
who participated in this study around the world. We are proud to have completed the first prophylactic, randomized, double-blind study
including patient reported outcomes for prevention of cancer therapy-related diarrhea. The study prioritized standard of cancer care for
study participants, with Jaguar's endorsement," Conte said. "As Jaguar continues the journey to bring crofelemer to
people living with a cancer diagnosis, we remain fully committed to expanding our commercial footprint beyond HIV-related supportive care.
In Q4 2024, we will launch the FDA-approved oral mucositis prescription product Gelclair for the U.S. market. Oral mucositis is a
dose-limiting side effect of cancer treatment, with more than one-third of patients discontinuing treatment because of the condition.1
Additionally, crofelemer is in multiple clinical investigations globally for the orphan indications of short bowel syndrome and microvillus
inclusion disease - an ultrarare congenital diarrheal disorder - with proof-of-concept data targeted for end of 2024 and throughout
Instructions for Webcast
When: Tuesday, July 23,
2024 at 8:30 AM Eastern Time
Participant Registration &
Access Link: Click Here
Replay Instructions for Webcast
Replay of the webcast
on the investor relations section of Jaguar's website: (click here)
About the Phase 3 OnTarget Clinical Trial
The multicenter double-blind, placebo-controlled OnTarget study is
a first-of-its-kind prophylactic clinical trial with a primary endpoint based on patient-reported outcomes that address the highly neglected
and unmet burden of cancer therapy-related diarrhea. The study evaluated the efficacy of crofelemer, a botanical drug that modulates intestinal
chloride ion channels, for its ability to prevent or substantially reduce cancer therapy-related diarrhea over the 12-week treatment period,
compared to placebo. The trial involved 10 different tumor types and 24 different targeted agents, with and without multiple standard
cytotoxic chemotherapies. Patients then had the opportunity to continue in a blinded 12-week extension of their phase 1 therapy. A majority
of the patients chose to continue.
Crofelemer is the only oral prescription drug approved under FDA botanical
guidance. It is plant-based, extracted and purified from the red bark sap of the Croton lechleri tree in the Amazon rainforest.
Jaguar family company Napo Pharmaceuticals has established a sustainable harvesting program, under fair trade practices, for crofelemer
to ensure a high degree of quality, ecological integrity, and support for Indigenous communities.
About the Jaguar Health Family of Companies
Jaguar Health, Inc. (Jaguar) is
a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants
from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes
symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals
(Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected
gastrointestinal symptoms across multiple complicated disease states. Napo's crofelemer is FDA-approved under the brand name Mytesi
for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics
is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically
for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar
and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel
prescription medicines derived from plants for mental health indications.
For more information about:
Jaguar Health, visit https://jaguar.health
Napo Pharmaceuticals, visit www.napopharma.com
Napo Therapeutics, visit napotherapeutics.com
Magdalena Biosciences, visit magdalenabiosciences.com
Visit the Make Cancer Less Shitty
patient advocacy program at makecancerlessshitty.com and on X, Facebook & Instagram
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking