Top Line Data for Jaguar Health’s Pivotal Phase 3 OnTarget Trial for Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Therapy Forthcoming

SAN FRANCISCO, CA / ACCESSWIRE / November 21, 2023 / Napo Pharmaceuticals (Napo), a Jaguar Health, Inc. (NASDAQ:JAGX) family company, today announced that the company has not yet been provided with results from the company's GCP (Good Clinical Practice) vendors supporting Napo's pivotal Phase 3 OnTarget trial. The trial is evaluating the company's plant-based prescription drug crofelemer for prophylaxis of diarrhea in adult cancer patients with solid tumors receiving targeted therapy, with or without standard chemotherapy. The top line results of the study are forthcoming.

"Napo and all key study-related personnel remain blinded to study results at this time. The OnTarget trial is our paramount near-term clinical milestone," said Lisa Conte, Jaguar's president and CEO. "We look forward to announcing and presenting the top line results when they are available."

The company's abstract outlining the design of the OnTarget trial and the neglected medical need has been accepted by the December 2023 San Antonio Breast Cancer Symposium. Diarrhea is a common side effect of targeted therapies and new treatments are needed.

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 chemotherapy-induced overactive bowel (CIOB), including specifically diarrhea/loose watery stools. 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 and symptoms of CIOB over the 12-week treatment period, compared to placebo.

About Crofelemer

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, and bowel incontinence. Jaguar family company Napo Pharmaceuticals focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo Pharmaceuticals' crofelemer drug candidate is the subject of the OnTarget study, a pivotal Phase 3 clinical trial for preventive treatment of chemotherapy-induced overactive bowel (CIOB) in adults with cancer and on targeted 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.

For more information about:

• Jaguar Health, please visit https://jaguar.health
• Napo Pharmaceuticals, visit napopharma.com

Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that the top line results of the OnTarget trial are forthcoming. 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 several 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.

CONTACT:

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SOURCE: Jaguar Health, Inc.