Patient Enrollment Surpasses 90% in Jaguar Health's Pivotal Phase 3 OnTarget Trial of Crofelemer for Cancer Therapy-Related Diarrhea

Rhea-AI Summary

Jaguar Health (Nasdaq:JAGX) announced that enrollment in its pivotal Phase 3 OnTarget clinical trial of crofelemer has surpassed 90%, with completion expected by mid-Q2 2023. This trial aims to assess the effectiveness of crofelemer in preventing diarrhea in adult cancer patients undergoing targeted therapy. The company’s current cash position stands at approximately $15.3 million. The OnTarget trial, now expanded to include sites in Eastern Europe, Argentina, and Taiwan, is crucial in demonstrating that chronic diarrhea affects patient adherence to cancer therapies. The trial evaluates crofelemer’s unique mechanism of action, targeting chloride ion channels in the gastrointestinal tract.

Positive

• Patient enrollment in the OnTarget trial has surpassed 90%, indicating strong study progress.
• Cash position of approximately $15.3 million, supporting ongoing and future operations.
• Expansion of trial sites to international locations may enhance patient recruitment and trial results.

Negative

• None.

Enrollment expected to complete in mid-Q2 2023

As of March 24, 2023, as previously announced, the Company's cash position was approximately $15.3 million

SAN FRANCISCO, CA / ACCESSWIRE / April 11, 2023 / Jaguar Health, Inc. (Nasdaq:JAGX) ("Jaguar" or the "Company") today announced that patient enrollment has surpassed 90% in the Company's pivotal Phase 3 OnTarget clinical trial of crofelemer for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy with or without chemotherapy.

"Just the week before last - on March 27^th - we announced that patient enrollment in OnTarget had reached approximately 80%, and we are very happy to report that enrollment in OnTarget is now already above 90%," said Lisa Conte, Jaguar's president and CEO. "Our efforts over the past year to expand the OnTarget trial to new U.S. and international sites - with trial sites now active in Eastern Europe - in both Georgia and the Republic of Serbia - as well as in Argentina and Taiwan - have significantly accelerated patient enrollment, and we now expect target trial enrollment of 256 patients to complete by mid-second quarter of 2023."

The Company's expectation is that the placebo controlled OnTarget trial will provide evidence that diarrhea associated with targeted cancer therapies is chronic, not acute, and impacts the patient's ability to remain on their cancer therapy regimens at proven doses for better outcomes. The OnTarget trial is evaluating the effectiveness of crofelemer's novel mechanism of action - the modulation of two chloride ion channels in the gastrointestinal tract - to mitigate or substantially reduce chronic cancer therapy-related diarrhea.

About Cancer Therapy-Related Diarrhea

A significant proportion of patients undergoing cancer therapy experience diarrhea, and diarrhea has the potential to cause dehydration, potential infections, and non-adherence to treatment in this population. Novel "targeted cancer therapy" agents, such as epidermal growth factor receptor (EGFR) antibodies and tyrosine kinase inhibitors (TKIs), with or without cycle chemotherapy agents, may cause increased electrolyte and fluid content in the gut lumen, which results in passage of loose/watery stools (i.e., diarrhea). Diarrhea has been reported as one of the most common side effects of TKIs and may result in cancer therapy drug holidays or reductions from therapeutic dose, potentially impacting patient outcome. Diarrhea is also a common side effect of some approved CDK 4/6 inhibitors.

About Jaguar Health, Napo Pharmaceuticals, Napo Therapeutics & Jaguar Animal Health

Jaguar Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel, plant-based, sustainably derived prescription medicines for people and animals with GI distress, including chronic, debilitating diarrhea. Jaguar Health's wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human pharmaceuticals from plants harvested responsibly from rainforest areas. Our crofelemer drug product candidate is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy. Jaguar Health is the majority shareholder of Napo Therapeutics S.p.A. (f/k/a Napo EU S.p.A.), an Italian corporation established by Jaguar Health in Milan, Italy in 2021 that focuses on expanding crofelemer access in Europe. Jaguar Animal Health is a tradename of Jaguar Health.

For more information about Jaguar Health, please visit https://jaguar.health. For more information about Napo Pharmaceuticals, visit www.napopharma.com. For more information about Napo Therapeutics, visit napotherapeutics.com.

Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that enrollment in the OnTarget trial will complete in the middle of the second quarter of 2023, and the Company's expectation that the OnTarget trial will provide evidence that diarrhea associated with targeted cancer therapies is chronic, not acute, and impacts the patient's ability to remain on their cancer therapy regimens at proven doses for better outcomes. 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.

Contact:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

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https://www.accesswire.com/748348/Patient-Enrollment-Surpasses-90-in-Jaguar-Healths-Pivotal-Phase-3-OnTarget-Trial-of-Crofelemer-for-Cancer-Therapy-Related-Diarrhea

FAQ

What is the OnTarget trial by Jaguar Health?

The OnTarget trial is a pivotal Phase 3 clinical study evaluating crofelemer's effectiveness in preventing diarrhea in adult cancer patients receiving targeted therapy.

When is the OnTarget trial enrollment expected to complete?

Enrollment for the OnTarget trial is expected to complete by mid-Q2 2023.

What are the implications of chronic diarrhea for cancer patients?

Chronic diarrhea can lead to dehydration and treatment non-adherence, impacting cancer therapy outcomes.

What is Jaguar Health's current cash position?

As of March 24, 2023, Jaguar Health's cash position was approximately $15.3 million.

What does the OnTarget trial aim to prove regarding diarrhea in cancer therapy?

The trial aims to provide evidence that diarrhea associated with targeted cancer therapies is chronic and can hinder patient adherence to treatment regimens.