Significant Positive Results with Jaguar Health's Crofelemer for Cancer Therapy-Related Diarrhea (CTD) in Breast Cancer Patients Presented at San Antonio Breast Cancer Symposium (SABCS)
Jaguar Health (NASDAQ:JAGX) announced significant positive results from its Phase 3 OnTarget trial evaluating crofelemer for cancer therapy-related diarrhea (CTD) in breast cancer patients. The trial included 183 breast cancer patients out of 287 total participants. 47.1% of patients receiving crofelemer were responders through 12 weeks, compared to 33.7% in the placebo group, showing statistically significant improvement in diarrhea control.
The study revealed that among breast cancer patients on abemaciclib, over 43% required dose reduction or termination due to diarrhea, while all patients on pertuzumab-based therapies needed dose adjustments. Napo Pharmaceuticals plans to submit these results to the FDA to discuss pathways for making crofelemer available to breast cancer patients.
Jaguar Health (NASDAQ:JAGX) ha annunciato risultati positivi significativi dal suo studio di Fase 3 OnTarget, che valuta il crofelemero per la diarrea correlata alla terapie oncologiche (CTD) nei pazienti affetti da cancro al seno. Lo studio ha incluso 183 pazienti con cancro al seno su un totale di 287 partecipanti. Il 47,1% dei pazienti trattati con crofelemero ha mostrato una risposta nel corso di 12 settimane, rispetto al 33,7% nel gruppo di controllo, dimostrando un miglioramento statisticamente significativo nel controllo della diarrea.
La ricerca ha rivelato che tra i pazienti con cancro al seno in trattamento con abemaciclib, oltre il 43% ha dovuto ridurre la dose o interrompere il trattamento a causa della diarrea, mentre tutti i pazienti in terapia con pertuzumab hanno necessitato di adeguamenti della dose. Napo Pharmaceuticals prevede di presentare questi risultati alla FDA per discutere le modalità di resa disponibile del crofelemero per i pazienti affetti da cancro al seno.
Jaguar Health (NASDAQ:JAGX) anunció resultados positivos significativos de su ensayo de Fase 3 OnTarget que evalúa el crofelemero para la diarrea relacionada con la terapia en pacientes con cáncer de mama. El ensayo incluyó a 183 pacientes con cáncer de mama de un total de 287 participantes. El 47.1% de los pacientes que recibieron crofelemero fueron respondedores a lo largo de 12 semanas, en comparación con el 33.7% en el grupo placebo, mostrando una mejora estadísticamente significativa en el control de la diarrea.
El estudio reveló que entre los pacientes con cáncer de mama que usaban abemaciclib, más del 43% requirió reducción de dosis o interrupción del tratamiento debido a la diarrea, mientras que todos los pacientes en tratamientos basados en pertuzumab necesitaron ajustes de dosis. Napo Pharmaceuticals planea presentar estos resultados a la FDA para discutir vías para hacer que el crofelemero esté disponible para pacientes con cáncer de mama.
재규어 헬스 (NASDAQ:JAGX)는 유방암 환자의 암 치료 관련 설사(CTD)를 평가하는 3상 혈관 대상 시험의 긍정적인 중요한 결과를 발표했습니다. 이 시험에는 287명의 전체 참가자 중 183명의 유방암 환자가 포함되었습니다. 크로페레머를 받은 환자의 47.1%가 12주 동안 반응을 보였습니다, 반면 위약 그룹에서는 33.7%가 반응을 보였으며, 설사 조절의 통계적으로 유의미한 개선을 나타냈습니다.
연구에 따르면, 아베마시클립을 복용한 유방암 환자 중 43% 이상이 설사로 인해 용량 감소 또는 치료 중단이 필요했으며, 모든 퍼투주맙 기반 치료를 받는 환자는 용량 조정이 필요했습니다. 나포 제약사는 이 결과를 FDA에 제출하여 유방암 환자를 위한 크로페레머의 사용 경로를 논의할 계획입니다.
Jaguar Health (NASDAQ:JAGX) a annoncé des résultats positifs significatifs de son essai de Phase 3 OnTarget évaluant le crofelemer pour la diarrhée associée aux thérapies anticancéreuses (CTD) chez les patientes atteintes d'un cancer du sein. L'essai a inclus 183 patientes atteintes d'un cancer du sein sur un total de 287 participants. 47,1 % des patientes recevant du crofelemer ont été des répondantes au bout de 12 semaines, contre 33,7 % dans le groupe placebo, montrant une amélioration statistiquement significative du contrôle de la diarrhée.
L'étude a révélé que parmi les patientes atteintes d'un cancer du sein sous abémaciclib, plus de 43 % ont nécessité une réduction ou l'arrêt du traitement en raison de la diarrhée, tandis que toutes les patientes sous thérapies basées sur le pertuzumab ont nécessité des ajustements de dose. Napo Pharmaceuticals prévoit de soumettre ces résultats à la FDA pour discuter des voies permettant de rendre le crofelemer disponible pour les patientes atteintes d'un cancer du sein.
Jaguar Health (NASDAQ:JAGX) gab bedeutende positive Ergebnisse aus seiner Phase-3-OnTarget-Studie bekannt, die Crofelemer zur Behandlung von krebsbedingtem Durchfall (CTD) bei Brustkrebspatienten bewertet. Die Studie umfasste 183 Brustkrebspatienten von insgesamt 287 Teilnehmern. 47,1 % der Patienten, die Crofelemer erhielten, waren über 12 Wochen hinweg ansprechbar, verglichen mit 33,7 % in der Placebogruppe, was eine statistisch signifikante Verbesserung der Durchfallkontrolle zeigt.
Die Studie ergab, dass unter Brustkrebspatienten, die Abemaciclib einnahmen, über 43 % eine Dosisreduktion oder Beendigung der Therapie aufgrund von Durchfall benötigten, während alle Patienten, die auf Pertuzumab-basierte Therapien angewiesen waren, Dosisanpassungen benötigten. Napo Pharmaceuticals plant, diese Ergebnisse der FDA vorzulegen, um Wege zur Verfügbarkeit von Crofelemer für Brustkrebspatienten zu diskutieren.
- Achieved statistically significant results in breast cancer patient subgroup
- 47.1% response rate in crofelemer group vs 33.7% in placebo group
- Plans to submit results to FDA for potential approval pathway
- 43% of abemaciclib patients required dose reduction or termination due to diarrhea
- 100% of pertuzumab-based therapy patients required dose adjustments
Insights
The phase 3 OnTarget trial results for crofelemer show compelling efficacy in managing cancer therapy-related diarrhea (CTD) in breast cancer patients. The 47.1% response rate in the crofelemer group versus 33.7% in placebo represents a statistically significant improvement. Most notably, the data from the placebo group revealed that 43% of patients on abemaciclib required dose adjustments due to diarrhea, while all patients on pertuzumab-based therapies needed dose modifications.
These findings are particularly significant as maintaining optimal dosing of cancer therapeutics is important for treatment success. The potential for crofelemer to enable patients to maintain their prescribed cancer treatment regimens could translate to improved therapeutic outcomes. The large sample size of 183 breast cancer patients from a total of 287 participants provides robust statistical power to support these conclusions.
This development represents a significant market opportunity for Jaguar Health. The breast cancer therapeutics market is substantial and the high incidence of treatment-related diarrhea presents a clear unmet medical need. With plans to submit these results to the FDA, crofelemer could potentially secure an additional indication, expanding its market reach. The fact that 100% of pertuzumab-based therapy patients required dose adjustments due to diarrhea underscores the magnitude of this opportunity.
For a company with a market cap of
Adult patients with breast cancer are a prespecified subgroup of the recently conducted phase 3 OnTarget trial evaluating crofelemer for prophylaxis of CTD
The majority of patients in the OnTarget placebo group on abemaciclib and pertuzumab-based therapies required dose reduction or elimination
SAN FRANCISCO, CA / ACCESSWIRE / December 12, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") family company Napo Pharmaceuticals ("Napo") today provided an overview of the data from the poster presentation conducted yesterday, December 11, 2024, at the San Antonio Breast Cancer Symposium (SABCS) 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 statistically significant results in this subgroup. 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.
"In this responder analysis of patients with breast cancer on targeted therapies, crofelemer CTD prophylaxis resulted in a greater proportion of monthly responders of diarrhea improvement compared to placebo," said Lisa Conte, Jaguar's president and CEO. "Overall, crofelemer was significantly more effective than placebo in providing sustained response in breast cancer patients, potentially helping them stay on their cancer therapies. This research underscores the potential of crofelemer for prophylaxis of CTD."
"Diarrhea is a common side effect of targeted therapies and can lead to dose changes, treatment delays, or stopping treatment altogether, all of which can impact patient outcomes," said Pablo C. Okhuysen, MD, FACP, FIDSA, the National Principal Investigator of the OnTarget trial. "The OnTarget study specifically analyzed breast cancer patients receiving crofelemer or a placebo for 12 weeks. Patients reported their diarrhea symptoms, and those with fewer than nine loose stools per week were considered ‘responders.' Breast cancer patients receiving crofelemer had significantly better control of diarrhea than those on placebo. Nearly half (
As announced, the content of the poster presentation will serve as the basis of the briefing package Napo plans 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 Jaguar believes data from additional analyses may result in future submissions to peer-reviewed forums.
A second poster related to the OnTarget trial, looking at the frequency and severity of diarrhea in breast cancer patients on abemaciclib and pertuzumab-based therapies, using data from the placebo group of OnTarget, was also the subject of a poster presentation on December 11, 2024 at SABCS. In the OnTarget study, 135 patients with various cancers received a placebo, and
"Of the total of 183 breast cancer patients in the OnTarget trial, most received abemaciclib or pertuzumab. Among those participating patients treated with abemaciclib, more than
Pablo C. Okhuysen, MD, FACP, FIDSA, the lead author of both posters, is Professor, Department of Infectious Diseases, Infection Control and Employee Health at The University of Texas MD Anderson Cancer Center in Houston. Other key authors of both posters 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.
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 hosted 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 anticipated 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 the potential of crofelemer for prophylaxis of CTD, Jaguar's expectations that the content of the poster about the results in breast cancer patients from the OnTarget study will serve as the basis of a briefing package Napo 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 Jaguar's expectation that more attention to managing diarrhea could improve quality of life and treatment success in breast cancer patients on targeted therapies. 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:
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SOURCE: Jaguar Health, Inc.
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FAQ
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