Poster Presentation Describing the Significant Results of Crofelemer for Cancer Therapy-Related Diarrhea (CTD) in Breast Cancer Patients to Take Place December 11, 2024 at San Antonio Breast Cancer Symposium (SABCS)
Rhea-AI Summary
Jaguar Health (NASDAQ:JAGX) announced that data from their Phase 3 OnTarget trial's breast cancer subgroup analysis will be presented at the San Antonio Breast Cancer Symposium (SABCS) on December 11, 2024. The presentation will highlight significant results of crofelemer for Cancer Therapy-Related Diarrhea (CTD) in breast cancer patients, who formed the majority of trial participants.
While the initial OnTarget study did not meet its primary endpoint across all tumor types, the breast cancer subgroup showed promising outcomes. The company plans to submit these findings to the FDA to discuss potential pathways for making crofelemer available to breast cancer patients. A full study report will be submitted to a peer-reviewed journal.
A second poster presentation focusing on the trial's placebo arm data will also be featured at SABCS, which expects over 10,000 attendees.
Positive
- Significant positive results achieved in breast cancer patient subgroup analysis
- Plans to pursue FDA pathway for crofelemer in breast cancer patients
- Study findings to be submitted to peer-reviewed journal
Negative
- OnTarget study failed to meet primary endpoint across all tumor types
News Market Reaction
On the day this news was published, JAGX gained 5.65%, reflecting a notable positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Adult patients with breast cancer are a prespecified subgroup of the recently conducted OnTarget trial evaluating crofelemer for prophylaxis of CTD
SAN FRANCISCO, CA / ACCESSWIRE / December 9, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that the data from the recently conducted analysis of the prespecified subgroup of adult patients with breast cancer from the Phase 3 OnTarget trial, which indicate that crofelemer achieved significant results in this subgroup, will be the subject of a poster presentation on December 11, 2024 during the 12:30 - 2:00 p.m. CST Poster Session 1 at the San Antonio Breast Cancer Symposium (SABCS), which takes place December 10-13, 2024 in San Antonio, Texas. 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 look forward to this presentation at SABCS. A full study report on the breast cancer subgroup analysis is expected to be submitted to a peer-reviewed journal," said Lisa Conte, Jaguar's president and CEO. "The content of the presentation will serve as the basis 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."
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 indicates that crofelemer achieved significant results in this subgroup.
A second poster presentation related to the OnTarget trial, based on data from the placebo arm of the study, will also take place during Poster Session 1 at SABCS on December 11, 2024.
In addition to participating in both poster presentations with its Scientific Advisory Board 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 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 on Bluesky, X, Facebook & Instagram
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that two poster presentations related to the OnTarget trial will take place at SABCS 2024, Jaguar's expectation that a full study report for the OnTarget results in breast cancer patients will be submitted to a peer-reviewed journal, Jaguar's expectation that the content of the presentation on the OnTarget results in breast cancer patients will serve as the basis of a 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.
Source: Jaguar Health, Inc.
Contact:
Jaguar-JAGX
SOURCE: Jaguar Health, Inc.
View the original press release on accesswire.com
FAQ
What were the results of JAGX's OnTarget trial for crofelemer in breast cancer patients?
When will JAGX present the crofelemer breast cancer trial results?
What are JAGX's next steps for crofelemer after the breast cancer trial results?
