Jaguar Health Reports Statistically Significant Improvement in Breast Cancer Patients in its Phase 3 OnTarget Trial for its Cancer Supportive Care Drug Crofelemer

Rhea-AI Summary

Jaguar Health (NASDAQ:JAGX) has reported statistically significant improvement in breast cancer patients in its Phase 3 OnTarget trial for crofelemer, a cancer supportive care drug. The trial evaluated crofelemer for prophylaxis of cancer therapy-related diarrhea. Breast cancer patients accounted for nearly 180 of the 287 participants in this prophylactic clinical trial.

While the initial top line results did not meet the primary estimand for all tumor types, the subgroup analysis in adult breast cancer patients showed clinically meaningful improvement. This suggests crofelemer's potential to help breast cancer patients better adhere to their cancer therapies. The results have been submitted to a relevant oncology conference, and a full study report is expected to be submitted to a peer-reviewed journal.

Additionally, crofelemer has shown benefit in patients with diarrhea-predominant irritable bowel syndrome (IBS-D), with results to be presented at the upcoming American College of Gastroenterology Annual Scientific Meeting.

Positive

• Statistically significant improvement in breast cancer patients subgroup
• Potential to improve adherence to cancer therapies for breast cancer patients
• Results submitted to oncology conference and peer-reviewed journal
• Demonstrated benefit in IBS-D patients

Negative

• Initial top line results did not meet primary estimand for all tumor types
• success to breast cancer subgroup, not across all solid tumors

Insights

Medical Research Analyst

The statistically significant improvement in breast cancer patients in Jaguar Health's Phase 3 OnTarget trial for crofelemer is a notable development. This subgroup analysis involved nearly 180 out of 287 participants, representing a substantial portion of the study population. The positive outcome in breast cancer patients is particularly significant given that the overall trial did not meet its primary endpoint across all tumor types.

Key points to consider:

• The responder analysis in breast cancer patients mirrors the approach used in the ADVENT trial, which led to FDA approval for crofelemer in HIV/AIDS-related diarrhea.
• Submission of results to an oncology conference and planned publication in a peer-reviewed journal indicate confidence in the data's validity and importance.
• The potential for crofelemer to improve therapy adherence in breast cancer patients could have significant clinical implications.
• Additional subgroup analyses are ongoing, which may reveal further positive outcomes in specific patient populations.

While this news is promising for Jaguar Health's cancer supportive care program, investors should note that further regulatory steps and potential label expansions would be necessary before this translates into new market opportunities. The company's strategy of exploring crofelemer's efficacy across various indications (including IBS-D) demonstrates a broad approach to maximizing the drug's potential.

Adult patients with breast cancer are a prespecified subgroup of the recently conducted OnTarget trial evaluating crofelemer for prophylaxis of cancer therapy-related diarrhea

OnTarget results in breast cancer patients have been submitted to a relevant oncology conference

SAN FRANCISCO, CA / ACCESSWIRE / October 1, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that the recently completed analysis of the prespecified subgroup of adult patients with breast cancer from the company's Phase 3 OnTarget trial indicate that crofelemer achieved statistical significance in this subgroup. Patients with breast cancer accounted for nearly 180 of the 287 participants in this unprecedented prophylactic clinical trial recently conducted by Jaguar family company Napo Pharmaceuticals for diarrhea in adult patients with solid tumors receiving targeted therapy with or without standard chemotherapy.

"The breast cancer results from OnTarget are a responder analysis, as was the primary endpoint in the phase 3 ADVENT trial that led to FDA approval of crofelemer for its currently commercialized indication for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy," said Lisa Conte, Jaguar's president and CEO. "This data in breast cancer patients has been submitted to a relevant oncology conference by the study's primary investigators, and a full study report for the breast cancer results is expected to be submitted to a peer-reviewed journal. Additional analyses of OnTarget prespecified subgroups are ongoing, and we believe data from additional analyses may result in future submissions to peer-reviewed forums."

As previously announced, the initial top line results from the OnTarget study showed that the multicenter, double-blind, placebo-controlled pivotal clinical trial did not meet its primary estimand for the prespecified analysis of all tumor types. The subgroup analysis in adult breast cancer patients demonstrates that crofelemer provides clinically meaningful improvement in this patient population, and suggests that crofelemer has the potential to help breast cancer patients to better adhere to their cancer therapies.

"Crofelemer has also demonstrated clinically meaningful benefit in patients with diarrhea-predominant irritable bowel syndrome (IBS-D), specifically functional and chronic idiopathic diarrhea. Those results will be presented at the American College of Gastroenterology Annual Scientific Meeting, which takes place October 25-30, 2024 in Philadelphia. Crofelemer's unique physiological mechanism of action allows clinically meaningful benefit to patients experiencing diarrhea and other gastrointestinal symptoms from various etiologies," said Conte.

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. 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 statements." These include statements regarding Jaguar's expectation that a full study report for the OnTarget breast cancer results will be submitted to a peer-reviewed journal, Jaguar's expectation that data from additional analyses of OnTarget prespecified subgroups may result in future submissions to peer-reviewed forums, Jaguar's expectation that crofelemer may have the potential to help breast cancer patients to better adhere to their cancer therapies, and the expectation that crofelemer results in patients with functional and chronic idiopathic diarrhea will be presented at the 2024 American College of Gastroenterology Annual Scientific Meeting. 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.

View the original press release on accesswire.com

FAQ

What were the results of Jaguar Health's Phase 3 OnTarget trial for crofelemer in breast cancer patients?

The Phase 3 OnTarget trial showed statistically significant improvement in breast cancer patients using crofelemer for prophylaxis of cancer therapy-related diarrhea. This subgroup analysis demonstrated clinically meaningful improvement in breast cancer patients, suggesting crofelemer's potential to help these patients better adhere to their cancer therapies.

How many breast cancer patients were included in Jaguar Health's OnTarget trial for JAGX?

The OnTarget trial included nearly 180 breast cancer patients out of a total of 287 participants with solid tumors receiving targeted therapy with or without standard chemotherapy.

What is the next step for Jaguar Health (JAGX) regarding the OnTarget trial results?

Jaguar Health has submitted the breast cancer results from the OnTarget trial to a relevant oncology conference. Additionally, a full study report for the breast cancer results is expected to be submitted to a peer-reviewed journal. The company is also conducting ongoing analyses of other prespecified subgroups from the trial.

Did Jaguar Health's OnTarget trial for JAGX meet its primary endpoint for all tumor types?

No, the initial top line results from the OnTarget study showed that the trial did not meet its primary estimand for the prespecified analysis of all tumor types. However, the subgroup analysis in adult breast cancer patients demonstrated clinically meaningful improvement.