Jaguar Health Reports Statistically Significant Improvement in Breast Cancer Patients in its Phase 3 OnTarget Trial for its Cancer Supportive Care Drug Crofelemer
Jaguar Health (NASDAQ:JAGX) has reported statistically significant improvement in breast cancer patients in its Phase 3 OnTarget trial for crofelemer, a cancer supportive care drug. The trial evaluated crofelemer for prophylaxis of cancer therapy-related diarrhea. Breast cancer patients accounted for nearly 180 of the 287 participants in this prophylactic clinical trial.
While the initial top line results did not meet the primary estimand for all tumor types, the subgroup analysis in adult breast cancer patients showed clinically meaningful improvement. This suggests crofelemer's potential to help breast cancer patients better adhere to their cancer therapies. The results have been submitted to a relevant oncology conference, and a full study report is expected to be submitted to a peer-reviewed journal.
Additionally, crofelemer has shown benefit in patients with diarrhea-predominant irritable bowel syndrome (IBS-D), with results to be presented at the upcoming American College of Gastroenterology Annual Scientific Meeting.
Jaguar Health (NASDAQ:JAGX) ha riportato un significativo miglioramento statistico nei pazienti con cancro al seno nel suo trial di fase 3 OnTarget per il crofelemer, un farmaco di supporto per il cancro. Il trial ha valutato il crofelemer per la profilassi della diarrea legata alla terapia oncologica. I pazienti con cancro al seno costituivano quasi 180 dei 287 partecipanti a questo trial clinico profilattico.
Sebbene i risultati iniziali non abbiano soddisfatto l'estimand primario per tutti i tipi di tumore, l'analisi dei sottogruppi in pazienti adulti con cancro al seno ha mostrato un miglioramento clinicamente significativo. Questo suggerisce il potenziale del crofelemer di aiutare i pazienti con cancro al seno a seguire meglio le loro terapie oncologiche. I risultati sono stati presentati a una conferenza oncologica pertinente e un rapporto completo dello studio è previsto essere inviato a una rivista con revisione paritaria.
Inoltre, il crofelemer ha mostrato benefici nei pazienti con sindrome dell'intestino irritabile predominante per la diarrea (IBS-D), con risultati che saranno presentati al prossimo Congresso Annuale della Accademia Americana di Gastroenterologia.
Jaguar Health (NASDAQ:JAGX) ha informado de una mejora estadísticamente significativa en pacientes con cáncer de mama en su ensayo de fase 3 OnTarget para el crofelemer, un medicamento de apoyo para el cáncer. El ensayo evaluó el crofelemer para la profilaxis de la diarrea relacionada con la terapia oncológica. Los pacientes con cáncer de mama representaron casi 180 de los 287 participantes en este ensayo clínico profiláctico.
Aunque los resultados iniciales no cumplieron con la estimación primaria para todos los tipos de tumores, el análisis de subgrupos en pacientes adultos con cáncer de mama mostró una mejora clínicamente significativa. Esto sugiere el potencial del crofelemer para ayudar a los pacientes con cáncer de mama a adherirse mejor a sus terapias oncológicas. Los resultados se han presentado a una conferencia de oncología relevante, y se espera que se envíe un informe completo del estudio a una revista revisada por pares.
Además, el crofelemer ha mostrado beneficios en pacientes con síndrome del intestino irritable predominante en diarrea (IBS-D), con resultados que se presentarán en el próximo Congreso Científico Anual del Colegio Americano de Gastroenterología.
재규어 헬스(Jaguar Health, NASDAQ:JAGX)는 통계적으로 유의미한 개선을 유방암 환자에서 나타냈다고 보고했습니다. 이는 유방암을 위한 돌봄 약물인 크로페레머(crofelemer)의 3상 OnTarget 임상 시험 결과입니다. 이 시험은 암 치료와 관련된 설사의 예방을 위해 크로페레머를 평가했습니다. 유방암 환자는 이 예방 임상 시험에서 287명의 참가자 중 거의 180명을 차지했습니다.
초기 주요 결과는 모든 종양 유형에 대해 주요 추정치를 충족하지 못했지만, 성인 유방암 환자에 대한 하위 그룹 분석에서 임상적으로 의미 있는 개선이 나타났습니다. 이는 크로페레머가 유방암 환자들이 암 치료를 더 잘 따르도록 도와줄 가능성을 시사합니다. 이 결과는 관련 종양학 학회에 제출되었으며, 전체 연구 보고서는 동료 심사 저널에 제출될 것으로 예상됩니다.
또한, 크로페레머는 설사가 주요 증상인 과민성 대장 증후군(IBS-D) 환자에게도 이점을 보여주었으며, 그 결과는 예정된 미국 위장병 학회 연례 과학 회의에서 발표될 것입니다.
Jaguar Health (NASDAQ:JAGX) a signalé une amélioration statistiquement significative chez les patientes atteintes de cancer du sein dans son essai clinique de phase 3 OnTarget pour le crofelemer, un médicament de soins de soutien au cancer. L'essai a évalué le crofelemer pour la prophylaxie de la diarrhée liée à la thérapie contre le cancer. Les patientes atteintes de cancer du sein représentaient presque 180 des 287 participants à cet essai clinique prophylactique.
Bien que les résultats initiaux n'aient pas satisfait l'estimation primaire pour tous les types de tumeurs, l'analyse de sous-groupes chez les patientes adultes atteintes de cancer du sein a montré une amélioration cliniquement significative. Cela suggère le potentiel du crofelemer à aider les patientes atteintes de cancer du sein à mieux respecter leurs traitements oncologiques. Les résultats ont été soumis à une conférence oncologique pertinente, et un rapport complet de l'étude devrait être soumis à une revue par des pairs.
De plus, le crofelemer a montré des bénéfices chez les patients souffrant du syndrome de l'intestin irritable à prédominance diarrhéique (IBS-D), avec des résultats qui seront présentés lors de la prochaine réunion scientifique annuelle du Collège américain de gastro-entérologie.
Jaguar Health (NASDAQ:JAGX) hat eine statistisch signifikante Verbesserung bei Brustkrebspatienten in seiner Phase-3-OnTarget-Studie zu Crofelemer, einem unterstützenden Krebsmedikament, berichtet. Die Studie bewertete Crofelemer zur Prophylaxe von therapiebedingter Diarrhoe. Brustkrebspatienten machten fast 180 von 287 Teilnehmern an dieser prophylaktischen klinischen Studie aus.
Obwohl die ersten Gesamtergebnisse nicht die primäre Schätzung für alle Tumorarten erfüllten, zeigte die Subgruppenanalyse bei erwachsenen Brustkrebspatienten eine klinisch bedeutsame Verbesserung. Dies deutet auf das Potenzial von Crofelemer hin, Brustkrebspatienten zu helfen, ihre Krebstherapien besser einzuhalten. Die Ergebnisse wurden auf einer relevanten Onkologie-Konferenz präsentiert, und ein vollständiger Studienbericht wird voraussichtlich an eine Fachzeitschrift mit Peer-Review eingereicht werden.
Darüber hinaus hat Crofelemer auch Vorteile bei Patienten mit diarrhea-dominierendem Reizdarmsyndrom (IBS-D) gezeigt, und die Ergebnisse werden auf dem bevorstehenden Jahrestreffen des American College of Gastroenterology präsentiert.
- Statistically significant improvement in breast cancer patients subgroup
- Potential to improve adherence to cancer therapies for breast cancer patients
- Results submitted to oncology conference and peer-reviewed journal
- Demonstrated benefit in IBS-D patients
- Initial top line results did not meet primary estimand for all tumor types
- success to breast cancer subgroup, not across all solid tumors
Insights
The statistically significant improvement in breast cancer patients in Jaguar Health's Phase 3 OnTarget trial for crofelemer is a notable development. This subgroup analysis involved nearly 180 out of 287 participants, representing a substantial portion of the study population. The positive outcome in breast cancer patients is particularly significant given that the overall trial did not meet its primary endpoint across all tumor types.
Key points to consider:
- The responder analysis in breast cancer patients mirrors the approach used in the ADVENT trial, which led to FDA approval for crofelemer in HIV/AIDS-related diarrhea.
- Submission of results to an oncology conference and planned publication in a peer-reviewed journal indicate confidence in the data's validity and importance.
- The potential for crofelemer to improve therapy adherence in breast cancer patients could have significant clinical implications.
- Additional subgroup analyses are ongoing, which may reveal further positive outcomes in specific patient populations.
While this news is promising for Jaguar Health's cancer supportive care program, investors should note that further regulatory steps and potential label expansions would be necessary before this translates into new market opportunities. The company's strategy of exploring crofelemer's efficacy across various indications (including IBS-D) demonstrates a broad approach to maximizing the drug's potential.
Adult patients with breast cancer are a prespecified subgroup of the recently conducted OnTarget trial evaluating crofelemer for prophylaxis of cancer therapy-related diarrhea
OnTarget results in breast cancer patients have been submitted to a relevant oncology conference
SAN FRANCISCO, CA / ACCESSWIRE / October 1, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that the recently completed analysis of the prespecified subgroup of adult patients with breast cancer from the company's Phase 3 OnTarget trial indicate that crofelemer achieved statistical significance in this subgroup. Patients with breast cancer accounted for nearly 180 of the 287 participants in this unprecedented prophylactic clinical trial recently conducted by Jaguar family company Napo Pharmaceuticals for diarrhea in adult patients with solid tumors receiving targeted therapy with or without standard chemotherapy.
"The breast cancer results from OnTarget are a responder analysis, as was the primary endpoint in the phase 3 ADVENT trial that led to FDA approval of crofelemer for its currently commercialized indication for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy," said Lisa Conte, Jaguar's president and CEO. "This data in breast cancer patients has been submitted to a relevant oncology conference by the study's primary investigators, and a full study report for the breast cancer results is expected to be submitted to a peer-reviewed journal. 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 demonstrates that crofelemer provides clinically meaningful improvement in this patient population, and suggests that crofelemer has the potential to help breast cancer patients to better adhere to their cancer therapies.
"Crofelemer has also demonstrated clinically meaningful benefit in patients with diarrhea-predominant irritable bowel syndrome (IBS-D), specifically functional and chronic idiopathic diarrhea. Those results will be presented at the American College of Gastroenterology Annual Scientific Meeting, which takes place October 25-30, 2024 in Philadelphia. Crofelemer's unique physiological mechanism of action allows clinically meaningful benefit to patients experiencing diarrhea and other gastrointestinal symptoms from various etiologies," said Conte.
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 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 submitted to a peer-reviewed journal, Jaguar's expectation that data from additional analyses of OnTarget prespecified subgroups may result in future submissions to peer-reviewed forums, Jaguar's expectation that crofelemer may have the potential to help breast cancer patients to better adhere to their cancer therapies, and the expectation that crofelemer results in patients with functional and chronic idiopathic diarrhea will be presented at the 2024 American College of Gastroenterology Annual Scientific 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 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.
View the original press release on accesswire.com
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