Jaguar Health Announces Significant Results in Breast Cancer Patients Accepted for Presentation at Multinational Association of Supportive Care in Cancer (MASCC) Annual Meeting
Jaguar Health (NASDAQ:JAGX) announced significant results from their Phase 3 OnTarget study focusing on Mytesi (crofelemer) for cancer therapy-related diarrhea. The study's prespecified subgroup analysis of breast cancer patients showed statistically significant results, despite the trial not meeting its primary endpoint across all tumor types.
The company has secured a Type C Meeting with the FDA in Q2 2025 to discuss potential approval pathways for crofelemer in breast cancer patients. The trial included 183 breast cancer patients out of 287 total participants. The results will be presented at the MASCC Annual Meeting in Seattle (June 26-28, 2025).
Additionally, a second late-breaker abstract on oral mucositis in cancer patients has been accepted for presentation at the same MASCC meeting, highlighting the company's broader focus on cancer supportive care.
Jaguar Health (NASDAQ:JAGX) ha annunciato risultati significativi dal loro studio di Fase 3 OnTarget, focalizzato su Mytesi (crofelemer) per la diarrea correlata alla terapia oncologica. L'analisi predefinita del sottogruppo di pazienti con carcinoma mammario ha mostrato risultati statisticamente significativi, nonostante lo studio non abbia raggiunto l'endpoint primario considerando tutti i tipi di tumore.
L'azienda ha ottenuto un incontro di Tipo C con la FDA nel secondo trimestre 2025 per discutere le possibili vie di approvazione del crofelemer nei pazienti con carcinoma mammario. Lo studio ha incluso 183 pazienti con carcinoma mammario su un totale di 287 partecipanti. I risultati saranno presentati al MASCC Annual Meeting a Seattle (dal 26 al 28 giugno 2025).
Inoltre, un secondo abstract late-breaker sull'uso del farmaco per la mucosite orale nei pazienti oncologici è stato accettato per la presentazione allo stesso meeting MASCC, evidenziando l'interesse dell'azienda per le cure di supporto oncologiche.
Jaguar Health (NASDAQ:JAGX) anunció resultados significativos de su estudio de Fase 3 OnTarget, centrado en Mytesi (crofelemer) para la diarrea relacionada con la terapia contra el cáncer. El análisis predefinido del subgrupo de pacientes con cáncer de mama mostró resultados estadísticamente significativos, a pesar de que el ensayo no alcanzó el objetivo principal en todos los tipos de tumor.
La compañía ha asegurado una Reunión Tipo C con la FDA en el segundo trimestre de 2025 para discutir posibles vías de aprobación del crofelemer en pacientes con cáncer de mama. El ensayo incluyó a 183 pacientes con cáncer de mama de un total de 287 participantes. Los resultados se presentarán en la Reunión Anual de MASCC en Seattle (del 26 al 28 de junio de 2025).
Además, un segundo resumen late-breaker sobre mucositis oral en pacientes con cáncer ha sido aceptado para su presentación en la misma reunión MASCC, destacando el enfoque más amplio de la compañía en el cuidado de soporte oncológico.
Jaguar Health (NASDAQ:JAGX)는 암 치료 관련 설사에 대한 Mytesi (크로펠머)의 3상 OnTarget 연구에서 중요한 결과를 발표했습니다. 유방암 환자에 대한 사전 지정된 하위 그룹 분석에서 통계적으로 유의미한 결과가 나타났으나, 전체 종양 유형을 대상으로 한 시험의 주요 평가 변수는 달성하지 못했습니다.
회사는 2025년 2분기에 크로펠머의 유방암 환자 승인 경로 논의를 위해 FDA와의 유형 C 미팅을 확보했습니다. 이 임상시험에는 총 287명 중 183명의 유방암 환자가 포함되었습니다. 결과는 2025년 6월 26일부터 28일까지 시애틀에서 열리는 MASCC 연례회의에서 발표될 예정입니다.
또한, 암 환자의 구강 점막염에 관한 두 번째 레이트 브레이커 초록도 같은 MASCC 회의에서 발표가 승인되어, 회사가 암 환자 지원 치료에 더 넓게 집중하고 있음을 보여줍니다.
Jaguar Health (NASDAQ:JAGX) a annoncé des résultats significatifs issus de son étude de Phase 3 OnTarget, portant sur Mytesi (crofelemer) pour la diarrhée liée aux traitements anticancéreux. L'analyse prédéfinie du sous-groupe des patientes atteintes de cancer du sein a montré des résultats statistiquement significatifs, bien que l'étude n'ait pas atteint son critère principal sur l'ensemble des types de tumeurs.
L'entreprise a obtenu une réunion de type C avec la FDA au deuxième trimestre 2025 afin de discuter des voies potentielles d'approbation du crofelemer chez les patientes atteintes de cancer du sein. L'essai comprenait 183 patientes atteintes de cancer du sein sur un total de 287 participants. Les résultats seront présentés lors de la réunion annuelle MASCC à Seattle (du 26 au 28 juin 2025).
De plus, un second résumé late-breaker concernant la mucite buccale chez les patients cancéreux a été accepté pour présentation lors de la même réunion MASCC, soulignant l'engagement plus large de la société dans les soins de support en oncologie.
Jaguar Health (NASDAQ:JAGX) gab bedeutende Ergebnisse ihrer Phase-3-Studie OnTarget bekannt, die sich auf Mytesi (Crofelemer) bei therapiebedingtem Durchfall bei Krebspatienten konzentriert. Die vordefinierte Subgruppenanalyse von Brustkrebspatienten zeigte statistisch signifikante Ergebnisse, obwohl die Studie den primären Endpunkt für alle Tumorarten nicht erreichte.
Das Unternehmen hat für das zweite Quartal 2025 ein Type-C-Meeting mit der FDA vereinbart, um mögliche Zulassungswege für Crofelemer bei Brustkrebspatienten zu besprechen. Die Studie umfasste 183 Brustkrebspatienten von insgesamt 287 Teilnehmern. Die Ergebnisse werden auf dem MASCC-Jahrestreffen in Seattle (26.–28. Juni 2025) präsentiert.
Darüber hinaus wurde ein zweites Late-Breaker-Abstract zur oralen Mukositis bei Krebspatienten für die Präsentation auf derselben MASCC-Konferenz angenommen, was den breiteren Fokus des Unternehmens auf die supportive Krebstherapie unterstreicht.
- Statistically significant results in breast cancer patient subgroup
- FDA Type C Meeting secured for Q2 2025 to discuss approval pathway
- Large target market potential with 316,950 new breast cancer cases expected in 2025
- Phase 3 OnTarget study did not meet primary endpoint for all tumor types
- Product still requires FDA approval with uncertain timeline
- to breast cancer subgroup rather than broader cancer patient population
Insights
The acceptance of Jaguar Health's late-breaker abstract showcasing additional significant responder data for crofelemer (Mytesi) in breast cancer patients represents an important tactical pivot following the OnTarget study's overall mixed results. While the trial failed to meet its primary endpoint across all tumor types, the company is strategically leveraging the significant results in the breast cancer subgroup (183 of 287 participants) to pursue a more focused approval pathway.
The upcoming FDA Type C meeting in Q2 2025 is particularly significant as it provides Jaguar an opportunity to discuss expedited approval pathways specifically for prophylaxis of diarrhea in breast cancer patients receiving targeted therapies. This represents a substantial market opportunity given the 316,950 new breast cancer cases expected in 2025 and approximately 4 million women with a history of invasive breast cancer in the US.
Cancer therapy-related diarrhea (CTD) represents a critical unmet need in oncology supportive care, often leading to treatment modifications that can compromise therapeutic outcomes. The continuous responder data being presented at MASCC likely demonstrates sustained efficacy over the 3-month treatment period in this specific patient population, which would be clinically meaningful for maintaining treatment intensity and quality of life.
The additional acceptance of Jaguar's second late-breaker abstract on oral mucositis suggests the company is building a broader oncology supportive care pipeline beyond CTD, potentially expanding their addressable market in cancer supportive care.
Jaguar Health's strategic focus on the breast cancer subset from their OnTarget trial demonstrates smart pipeline management following mixed overall results. The statistically significant results in breast cancer patients provides a clearer regulatory pathway compared to pursuing approval across all solid tumors, potentially accelerating time-to-market for this specific indication.
The granted FDA Type C meeting represents a crucial de-risking event, as it allows the company to gain regulatory clarity before committing significant resources to additional trials or submissions. This targeted approach acknowledges market realities – the breast cancer segment alone represents a substantial commercial opportunity with over 316,000 new diagnoses annually plus millions living with the disease.
From a positioning perspective, crofelemer offers unique advantages as a plant-based, non-absorbable prescription medicine for CTD. This profile potentially addresses both efficacy needs and safety concerns for patients already managing complex treatment regimens. The company's patient advocacy focus through its "Make Cancer Less Shitty" program further strengthens their market positioning by directly addressing patient priorities in supportive care.
Napo's simultaneous work on oral mucositis indicates forward-looking pipeline development beyond their lead CTD program. This creates potential for multiple revenue streams within the oncology supportive care market, which remains underserved despite representing a critical component of cancer treatment success. The scientific validation through MASCC abstract acceptances enhances credibility with both clinical and patient communities.
The statistically significant responder analysis results for Mytesi® (crofelemer) in the Phase 3 OnTarget study's prespecified subgroup of patients with breast cancer were the subject of a December 2024 poster presentation at the San Antonio Breast Cancer Symposium
Late-breaker abstract accepted by MASCC shows additional significant results for breast cancer subgroup
Jaguar planning to meet with FDA in Q2 2025 to discuss possible pathways for crofelemer approval for prophylaxis of diarrhea in patients with breast cancer
A second late-breaker abstract, related to the results of a screening survey of cancer patients about oral mucositis and a follow-up focus group, has also been accepted for presentation at MASCC's 2025 Annual Meeting
SAN FRANCISCO, CA / ACCESS Newswire / April 15, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") family company Napo Pharmaceuticals ("Napo") today announced that the late-breaker abstract Napo submitted to MASCC on additional significant results in adult breast cancer patients from the OnTarget study has been accepted for presentation as an oral rapid e-poster at MASCC's June 26-28, 2025 Annual Meeting in Seattle, Washington. The authors include Pravin Chaturvedi, PhD, who is Jaguar's Chief Scientific Officer and Chair of Napo's Scientific Advisory Board, as well as leading oncologists and cancer patient advocates.
The abstract is titled OnTarget: Crofelemer or Placebo for the Prophylaxis of Diarrhea in Adults with Solid Tumors Initiating Targeted Therapy ± Chemotherapy (Tt/C)
"We're very pleased about the acceptance by MASCC of this new abstract, which describes the proportion of breast cancer patients who were continuous responders for the entire 3-month period of the OnTarget trial compared to breast cancer patients in the placebo arm of the study," said Lisa Conte, Jaguar's president and CEO.
"As a cancer patient, having options to manage the side effects of life saving drugs is very important. I believe the published results of crofelemer for the prophylaxis of cancer therapy-related are very exciting and compelling," said Dr. Kelly Shanahan, a former clinician and a metastatic breast cancer patient who serves on Napo's Scientific Advisory Board (SAB).
As announced, the U.S. Food and Drug Administration (FDA) has granted Napo a Type C Meeting in the second quarter of 2025 to discuss the responder analysis in the prespecified subgroup of patients with breast cancer for crofelemer in Napo's Phase 3 OnTarget trial. Patients with breast cancer accounted for 183 of the 287 participants in this unprecedented prophylactic clinical trial recently conducted by Napo for diarrhea in adults with solid tumors receiving targeted therapy with or without standard chemotherapy. The American Cancer Society expects 316,950 new cases of breast cancer diagnosed in women in the US in 2025,1 and it's estimated that there were 4 million US women with a history of invasive breast cancer in 2022.2
"Diarrhea is a common side effect of targeted cancer therapies and can lead to dose changes, treatment delays, or cessation of treatment altogether, all of which can impact patient outcomes. We are very happy to have been granted a meeting with the FDA to review the positive OnTarget results in breast cancer patients and our goal is to discuss the most efficient pathways to make crofelemer - our novel, oral plant-based prescription medicine - available to this patient population for cancer therapy-related diarrhea (CTD)," said Conte.
Members of Napo's SAB are expected to join Jaguar representatives at the FDA meeting in the second quarter of 2025.
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 endpoint 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.
Napo today also announced that a second late-breaker abstract, related to the results of a recent Napo-sponsored screening survey of cancer patients about oral mucositis and a follow-up focus group, has also been accepted for presentation at MASCC's 2025 Annual Meeting. The abstract is titled Beyond the Pain: Patient Insights on Oral Mucositis in Cancer Treatment.
"Oral mucositis is a common, painful, and life-altering side effect of cancer treatment, frequently disrupting eating, speaking, sleeping, and social interactions. Capturing real-world patient experiences and insights can help to identify patient priorities and co-create solutions to support prevention and management of oral mucositis and enhance quality of life," said Stacey Tinianov, 11-year cancer survivor and founder of Advocates for Collaborative Education who serves on Napo's SAB. "I am delighted and honored that the results of the screening survey and focus group will be presented at MASCC's Annual Meeting this June."
Ms. Tinianov coordinated the screening survey and focus group in conjunction with cancer patients who serve as Ambassadors for Napo's ongoing Make Cancer Less Shitty (MCLS) patient advocacy program. The goal of the MCLS program is to drive awareness of cancer supportive care gaps and needs, bring together patients, advocates, researchers, and clinicians, and, most importantly, to amplify the voice of patients about the importance of supportive care.
"Oral mucositis has impacted my daily life constantly since 2016. Without proper supportive care, I have raw mouth sores and ulcerations from my gums and lips all the way down my throat. When severe, it impacts what I am able to eat, how I'm able to eat, and sometimes my ability to talk. The pain and irritation from oral mucositis affects my sleep and my self-confidence," said JJ Singleton, a metastatic colon cancer survivor and an Ambassador for Napo's MCLS patient advocacy program.
MASCC is an international, interdisciplinary organization dedicated to the practice, education and research of supportive care in cancer. The organization's mission is to continually improve the supportive care of people with cancer - from diagnosis through to survival or end-of-life care.
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. Napo's crofelemer is FDA-approved under the brand name Mytesi® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral 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. 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 Napo will meet with the FDA in the second quarter of 2025 to discuss the results of the OnTarget study in breast cancer patients and potential pathways to bring crofelemer to this patient population as efficiently as possible for treatment of CTD, and the expectation that two Napo abstracts will be presented at MASCC's 2025 Annual 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 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.
1 Cancer Facts & Figures 2025, American Cancer Society
2 Miller KD, Siegel RL, Lin CC, et al. Cancer treatment and survivorship statistics, 2022. CA Cancer J Clin. 2022:1-23
Contact:
Jaguar-JAGX
SOURCE: Jaguar Health, Inc.
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FAQ
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