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

A second late-breaking abstract related to the OnTarget trial, based on data from the placebo arm of the study, has also been accepted for a poster presentation at SABCS

SAN FRANCISCO, CA / ACCESSWIRE / November 4, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") family company Napo Pharmaceuticals ("Napo") today announced that the late-breaking abstract about the recently completed analysis of the prespecified subgroup of adult patients with breast cancer from the Phase 3 OnTarget trial, which indicates that crofelemer achieved significant results in this subgroup, has been accepted for a poster presentation on December 11, 2024 at the San Antonio Breast Cancer Symposium (SABCS). Patients with breast cancer accounted for the majority of participants in this unprecedented prophylactic clinical trial recently conducted by Napo for diarrhea in adult patients with solid tumors receiving targeted therapy with or without standard chemotherapy.

"We are thrilled that this important abstract has been accepted for presentation at SABCS. A full study report on the breast cancer subgroup analysis will be presented at the meeting and is expected to be submitted to a peer-reviewed journal," said Lisa Conte, Jaguar's president and CEO. "The content of the abstract will serve as the cornerstone of the briefing package we plan to submit to the U.S. Food and Drug Administration to request a meeting to discuss possible pathways to make crofelemer available as efficiently as possible to breast cancer patients. Additional analyses of OnTarget prespecified subgroups are ongoing, and we believe data from additional analyses may result in future submissions to peer-reviewed forums."

The lead author of the abstract, and the National Principal Investigator of the OnTarget trial, is Pablo C. Okhuysen, MD, FACP, FIDSA, Professor, Department of Infectious Diseases, Infection Control and Employee Health at MD Anderson Cancer Center at the University of Texas in Houston. Other key authors of the abstract include Pravin Chaturvedi, PhD, Chair of Napo's Scientific Advisory Board (SAB) and Jaguar's Chief Scientific Officer; Napo SAB member Lee Schwartzberg, M.D., FACP, Chief of Medical Oncology at Renown Health in Reno, Nevada; Napo SAB member Eric Roeland, MD, FAAHPM, FASCO, Associate Professor of Medicine, Division of Hematology/Medical Oncology, School of Medicine, Oregon Health & Science University; Napo SAB member Stacey Tinianov, MPH, a Board Certified Patient Advocate; Napo SAB member Dr. Kelly Shanahan, a former clinician and a metastatic breast cancer patient who is now a full-time independent patient advocate; as well as two key advisors to Napo: Enoch Bortey and James Bolognese.

"It is an exciting time to be a part of the company's SAB," said Dr. Shanahan. "As a cancer patient, having options to manage the side effects of life saving drugs is very important. I believe studying crofelemer for the prophylaxis of CTD is very exciting. We cancer patients don't want to take a medication to deal with a side effect that in turn causes a different side effect."

A second late-breaking abstract related to the OnTarget trial, based on data from the placebo arm of the study, has also been accepted for a poster presentation on December 11, 2024 at SABCS.

In addition to participating in both poster presentations with its SAB members at SABCS, and in alignment with Jaguar's core focus on patient comfort, dignity, and cancer supportive care in general, Napo will be hosting a gathering for patient advocates during SABCS as part of the company's ongoing patient engagement program.

Since 1977, SABCS has been the leading scientific conference for scientists, physicians, clinical investigators, breast care providers, and advocates seeking an exchange of new information in experimental biology, etiology, prevention, diagnosis, and therapy of premalignant breast disease and breast cancer. Based on attendance levels from 2023 SABCS, the symposium organizers anticipate more than 10,000 attendees for this year's event.

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

Napo Pharmaceuticals, visit

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 presented at SABCS 2024 and submitted to a peer-reviewed journal, Jaguar's expectation that the content of the abstract will serve as the cornerstone of the briefing package the company will submit to the U.S. Food and Drug Administration to request a meeting to discuss possible pathways to make crofelemer available as efficiently as possible to breast cancer patients, Jaguar's expectation that data from additional analyses of OnTarget prespecified subgroups may result in future submissions to peer-reviewed forums, and the expectation that Napo will host a gathering for patient advocates during SABCS as part of the company's ongoing patient engagement program. 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.