Jaguar Health Meeting with FDA Regarding Results of Phase 3 OnTarget Study
Jaguar Health (NASDAQ:JAGX) has secured a Type C Meeting with the FDA in Q2 2025 to discuss the Phase 3 OnTarget trial results for Mytesi (crofelemer) in breast cancer patients. The trial focused on preventing diarrhea in adults with solid tumors receiving targeted therapy with or without standard chemotherapy.
While the overall trial did not meet its primary endpoint across all tumor types, the breast cancer subgroup, comprising 183 of 287 participants, showed statistically significant responder analysis results. The study demonstrated that crofelemer prophylaxis resulted in a greater proportion of monthly responders for diarrhea improvement compared to placebo in breast cancer patients.
A late-breaker abstract with additional significant results has been submitted to the Multinational Association of Supportive Care in Cancer (MASCC) for their June 2025 Annual Meeting. The American Cancer Society projects 316,950 new breast cancer cases in US women in 2025.
Jaguar Health (NASDAQ:JAGX) ha ottenuto un incontro di Tipo C con la FDA nel secondo trimestre del 2025 per discutere i risultati della fase 3 dello studio OnTarget per Mytesi (crofelemer) in pazienti con cancro al seno. Lo studio si è concentrato sulla prevenzione della diarrea negli adulti con tumori solidi sottoposti a terapia mirata con o senza chemioterapia standard.
Sebbene lo studio complessivo non abbia raggiunto il suo obiettivo primario per tutti i tipi di tumori, il sottogruppo di pazienti con cancro al seno, composto da 183 dei 287 partecipanti, ha mostrato risultati di analisi dei rispondenti statisticamente significativi. Lo studio ha dimostrato che la profilassi con crofelemer ha portato a una maggiore proporzione di rispondenti mensili per il miglioramento della diarrea rispetto al placebo nei pazienti con cancro al seno.
Un abstract di late-breaker con ulteriori risultati significativi è stato presentato all'Associazione Multinazionale per le Cure di Supporto nel Cancro (MASCC) per la loro Riunione Annuale di Giugno 2025. La Società Americana del Cancro prevede 316.950 nuovi casi di cancro al seno tra le donne statunitensi nel 2025.
Jaguar Health (NASDAQ:JAGX) ha asegurado una reunión de Tipo C con la FDA en el segundo trimestre de 2025 para discutir los resultados del ensayo de fase 3 OnTarget para Mytesi (crofelemer) en pacientes con cáncer de mama. El ensayo se centró en prevenir la diarrea en adultos con tumores sólidos que reciben terapia dirigida con o sin quimioterapia estándar.
Aunque el ensayo general no cumplió con su objetivo primario en todos los tipos de tumores, el subgrupo de cáncer de mama, que comprende 183 de los 287 participantes, mostró resultados de análisis de respondedores estadísticamente significativos. El estudio demostró que la profilaxis con crofelemer resultó en una mayor proporción de respondedores mensuales para la mejora de la diarrea en comparación con el placebo en pacientes con cáncer de mama.
Se ha presentado un resumen de late-breaker con resultados adicionales significativos a la Asociación Multinacional de Cuidados de Soporte en Cáncer (MASCC) para su Reunión Anual de junio de 2025. La Sociedad Americana del Cáncer proyecta 316,950 nuevos casos de cáncer de mama en mujeres estadounidenses en 2025.
재규어 헬스 (NASDAQ:JAGX)는 2025년 2분기에 FDA와의 타입 C 회의를 확보하여 마이테시 (크로펠레머)의 유방암 환자에 대한 3상 온타겟 시험 결과를 논의할 예정입니다. 이 시험은 표적 치료를 받는 고형 종양 성인의 설사 예방에 중점을 두었습니다.
전체 시험은 모든 종양 유형에서 주요 목표를 달성하지 못했지만, 유방암 하위 그룹인 287명의 참가자 중 183명이 통계적으로 유의미한 반응자 분석 결과를 보여주었습니다. 이 연구는 크로펠레머 예방이 유방암 환자에서 설사 개선을 위한 월간 반응자의 비율을 위약보다 높였음을 입증했습니다.
추가적인 중요한 결과를 포함한 Late-breaker 초록이 2025년 6월 연례 회의를 위해 다국적 암 지원 치료 협회(MASCC)에 제출되었습니다. 미국 암 학회는 2025년에 미국 여성에서 316,950개의 새로운 유방암 사례가 발생할 것으로 예상하고 있습니다.
Jaguar Health (NASDAQ:JAGX) a obtenu une réunion de type C avec la FDA au deuxième trimestre 2025 pour discuter des résultats de l'essai de phase 3 OnTarget pour Mytesi (crofelemer) chez les patientes atteintes de cancer du sein. L'essai s'est concentré sur la prévention de la diarrhée chez les adultes atteints de tumeurs solides recevant une thérapie ciblée avec ou sans chimiothérapie standard.
Bien que l'essai global n'ait pas atteint son objectif principal pour tous les types de tumeurs, le sous-groupe de cancer du sein, comprenant 183 des 287 participants, a montré des résultats d'analyse des répondants statistiquement significatifs. L'étude a démontré que la prophylaxie par crofelemer a entraîné une plus grande proportion de répondants mensuels pour l'amélioration de la diarrhée par rapport au placebo chez les patientes atteintes de cancer du sein.
Un résumé late-breaker avec des résultats supplémentaires significatifs a été soumis à l'Association Multinationale de Soins de Support en Cancérologie (MASCC) pour leur réunion annuelle de juin 2025. La Société Américaine du Cancer prévoit 316 950 nouveaux cas de cancer du sein chez les femmes américaines en 2025.
Jaguar Health (NASDAQ:JAGX) hat im zweiten Quartal 2025 ein Typ-C-Meeting mit der FDA gesichert, um die Ergebnisse der Phase-3-OnTarget-Studie für Mytesi (Crofelemer) bei Brustkrebspatienten zu diskutieren. Die Studie konzentrierte sich darauf, Durchfall bei Erwachsenen mit soliden Tumoren zu verhindern, die eine zielgerichtete Therapie mit oder ohne Standardchemotherapie erhalten.
Obwohl die gesamte Studie ihr primäres Ziel bei allen Tumorarten nicht erreicht hat, zeigte die Brustkrebs-Untergruppe, die aus 183 der 287 Teilnehmer bestand, statistisch signifikante Ergebnisse der Antwortanalyse. Die Studie zeigte, dass die Prophylaxe mit Crofelemer zu einem höheren Anteil an monatlichen Respondenten zur Verbesserung des Durchfalls im Vergleich zu Placebo bei Brustkrebspatienten führte.
Ein Late-Breaker-Abstract mit weiteren signifikanten Ergebnissen wurde der Multinationalen Vereinigung für Unterstützende Pflege bei Krebs (MASCC) für ihre Jahrestagung im Juni 2025 eingereicht. Die American Cancer Society prognostiziert 316.950 neue Brustkrebsfälle bei US-Frauen im Jahr 2025.
- Significant positive results in breast cancer subgroup analysis
- FDA Type C Meeting secured for Q2 2025
- Large potential market with 316,950 projected new breast cancer cases in 2025
- Demonstrated superior efficacy vs placebo in breast cancer patients
- Overall trial failed to meet primary endpoint across all tumor types
Insights
The FDA granting Jaguar Health a Type C meeting to discuss breast cancer subgroup results from their Phase 3 OnTarget trial represents a mixed regulatory development. While the overall trial failed to meet its primary endpoint across all tumor types, the company is pursuing a potential regulatory pathway based on statistically significant results in the breast cancer subgroup (183 of 287 participants).
This strategy of pursuing a subgroup analysis after a failed primary endpoint is challenging from a regulatory perspective. The FDA typically views such approaches with skepticism, as they raise concerns about data mining. However, the fact that this was a prespecified subgroup strengthens Jaguar's position considerably compared to post-hoc analyses.
Type C meetings are used to discuss development programs, providing sponsors with FDA feedback without the formal nature of Type B meetings. The granting of this meeting suggests the FDA sees enough merit in the data to warrant discussion, but doesn't guarantee a pathway to approval.
The breast cancer market represents a substantial opportunity with 316,950 new cases expected in 2025 and approximately 4 million women with a history of invasive breast cancer. The potential regulatory pathway would likely be narrow - targeting specifically breast cancer patients on targeted therapies experiencing cancer therapy-related diarrhea (CTD).
Investors should understand that even with positive subgroup results, the company faces regulatory hurdles. The FDA may require additional studies, potentially with breast cancer patients as the primary population, before considering approval.
The OnTarget trial results reveal important nuances that deserve careful interpretation. This was a prophylactic trial - testing crofelemer's ability to prevent diarrhea in cancer patients receiving targeted therapies, rather than treating already-established symptoms. This prevention approach is particularly valuable for maintaining dose intensity of cancer treatments.
The breast cancer subgroup data shows crofelemer produced a greater proportion of monthly responders compared to placebo and was significantly more effective in providing sustained response. These endpoints focus on durability of effect - crucial for patients on ongoing cancer therapies where treatment interruptions can impact outcomes.
From a clinical perspective, cancer therapy-related diarrhea (CTD) represents a significant unmet need. Diarrhea from targeted therapies can lead to dose reductions, delays, or treatment discontinuation, potentially compromising cancer outcomes. Current management options are and often ineffective.
The breast cancer focus makes clinical sense given the prevalence of targeted therapies in this population (CDK4/6 inhibitors, PI3K inhibitors, HER2-targeted therapies) that frequently cause diarrhea. Crofelemer's plant-based nature and novel mechanism addressing chloride ion channel-mediated fluid secretion provides a differentiated approach compared to conventional antidiarrheals.
While subgroup analyses must be interpreted cautiously, the fact this was prespecified strengthens the findings' validity. The additional significant results being presented at MASCC could provide further support for efficacy in this population.
The statistically significant responder analysis results for Mytesi® (crofelemer) in the 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 recently submitted to the Multinational Association of Supportive Care in Cancer (MASCC) shows additional significant results for breast cancer subgroup
The American Cancer Society expects 316,950 new cases of breast cancer diagnosed in women in the US in 2025, and it's estimated that there were 4 million US women with a history of invasive breast cancer in 2022
SAN FRANCISCO, CA / ACCESS Newswire / March 27, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") family company Napo Pharmaceuticals ("Napo") today announced that 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
Napo recently submitted a late-breaker abstract to MASCC on additional significant results in adult breast cancer patients from the OnTarget study for consideration for presentation 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.
"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 CTD 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).
"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 Lisa Conte, Jaguar's president and CEO. "In this responder analysis of patients with breast cancer on targeted therapies, crofelemer prophylaxis resulted in a greater proportion of monthly responders of diarrhea improvement compared to placebo. Overall, crofelemer was significantly more effective than placebo in providing sustained response in breast cancer patients."
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.
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. 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:
hello@jaguar.health
Jaguar-JAGX
SOURCE: Jaguar Health, Inc.
View the original press release on ACCESS Newswire
FAQ
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