Jaguar Health Reports Phase 3 OnTarget Trial Results for its Cancer Supportive Care Drug Crofelemer
Jaguar Health (NASDAQ:JAGX) announced results from its Phase 3 OnTarget trial of crofelemer for prophylaxis of diarrhea in adult cancer patients with solid tumors receiving targeted therapy. The trial did not meet its primary endpoint across all tumor types. However, it revealed clinically relevant signals for crofelemer in prespecified subgroups of patients with breast and respiratory cancer, including lung cancer. These subgroups comprised over 75% of trial participants.
Key takeaways:
- Trial included 10 tumor types and 24 targeted agents
- Positive signals improved over the initial 12-week phase
- Crofelemer was well-tolerated with an adverse event profile similar to placebo
- Company plans to engage with FDA after full data review
Jaguar will host an investor webcast on July 23, 2024, to provide updates on its cancer supportive care portfolio.
Jaguar Health (NASDAQ:JAGX) ha annunciato i risultati del suo trial di Fase 3 OnTarget per la profilassi della diarrea in pazienti adulti con tumori solidi che ricevono terapie mirate. Lo studio non ha raggiunto il suo obiettivo primario per tutti i tipi di tumore. Tuttavia, ha rivelato segnali clinicamente rilevanti per il crofelemer in sottoinsiemi predefiniti di pazienti con cancro al seno e respiratorio, incluso il cancro ai polmoni. Questi sottoinsiemi rappresentavano oltre il 75% dei partecipanti allo studio.
Aspetti chiave:
- Lo studio ha incluso 10 tipi di tumore e 24 agenti mirati
- I segnali positivi sono migliorati durante la fase iniziale di 12 settimane
- Il crofelemer è stato ben tollerato con un profilo di eventi avversi simile al placebo
- L'azienda prevede di interagire con la FDA dopo una revisione completa dei dati
Jaguar ospiterà un webcast per investitori il 23 luglio 2024 per fornire aggiornamenti sul suo portafoglio di supporto per il cancro.
Jaguar Health (NASDAQ:JAGX) anunció los resultados de su ensayo de Fase 3 OnTarget para la profilaxis de la diarrea en pacientes adultos con tumores sólidos que recibieron terapia dirigida. El ensayo no cumplió con su objetivo primario en todos los tipos de tumor. Sin embargo, reveló
Aspectos clave:
- El ensayo incluyó 10 tipos de tumor y 24 agentes dirigidos
- Los signos positivos mejoraron durante la fase inicial de 12 semanas
- El crofelemer fue bien tolerado con un perfil de eventos adversos similar al placebo
- La empresa planea interactuar con la FDA después de una revisión completa de los datos
Jaguar organizará un seminario web para inversores el 23 de julio de 2024, para proporcionar actualizaciones sobre su cartera de apoyo al cáncer.
재규어 헬스(NASDAQ:JAGX)는 타겟 치료를 받는 고형 종양 성인 암 환자의 설사 예방을 위한 3상 온타겟 임상시험 결과를 발표했습니다. 이 시험은 모든 종양 유형에서 주요 목표를 달성하지 못했습니다. 그러나 유방암 및 호흡기암(폐암 포함)에 대한 사전 설정된 환자 하위 그룹에서 임상적으로 중요한 신호를 나타냈습니다. 이러한 하위 그룹은 시험 참가자의 75% 이상을 차지했습니다.
주요 내용:
- 시험에는 10종의 종양과 24종의 타겟 약물이 포함되었습니다.
- 긍정적인 신호는 초기 12주 동안 개선되었습니다.
- 크로펠레머는 위약과 유사한 부작용 프로파일로 잘 견뎌졌습니다.
- 회사는 전체 데이터 검토 후 FDA와 소통할 계획입니다.
재규어는 2024년 7월 23일 투자자 웹캐스트를 개최하여 암 지원 치료 포트폴리오에 대한 업데이트를 제공할 예정입니다.
Jaguar Health (NASDAQ:JAGX) a annoncé les résultats de son essai de Phase 3 OnTarget concernant le crofelemer pour la prophylaxie de la diarrhée chez les adultes atteints de cancers solides recevant une thérapie ciblée. L'essai n'a pas atteint son objectif principal pour tous les types de tumeurs. Cependant, il a révélé des signaux cliniquement pertinents pour le crofelemer dans des sous-groupes prédéfinis de patients atteints de cancer du sein et respiratoire, y compris le cancer des poumons. Ces sous-groupes représentaient plus de 75% des participants à l'essai.
Points clés :
- L'essai a inclus 10 types de tumeurs et 24 agents ciblés
- Les signaux positifs se sont améliorés au cours de la phase initiale de 12 semaines
- Le crofelemer a été bien toléré avec un profil d'événements indésirables similaire à celui du placebo
- L'entreprise prévoit de dialoguer avec la FDA après un examen complet des données
Jaguar organisera un webinaire pour les investisseurs le 23 juillet 2024 afin de fournir des mises à jour sur son portefeuille de soins de soutien en oncologie.
Jaguar Health (NASDAQ:JAGX) hat die Ergebnisse seiner Phase-3-OnTarget-Studie zu crofelemer zur Prophylaxe von Durchfall bei erwachsenen Krebspatienten mit soliden Tumoren, die eine gezielte Therapie erhalten, veröffentlicht. Die Studie erreichte nicht ihr primäres Ziel über alle Tumorarten hinweg. Allerdings wurden klinisch relevante Signale für Crofelemer in vordefinierten Subgruppen von Patienten mit Brust- und Atemwegskrebs, einschließlich Lungenkrebs, festgestellt. Diese Subgruppen umfassten über 75% der Studien-Teilnehmer.
Wichtige Erkenntnisse:
- Die Studie umfasste 10 Tumorarten und 24 gezielte Wirkstoffe
- Positive Signale verbesserten sich über die initiale 12-Wochen-Phase
- Crofelemer wurde gut vertragen mit einem Nebenwirkungsprofil, das dem von Placebo ähnlich ist
- Das Unternehmen plant eine Kontaktaufnahme mit der FDA nach vollständiger Datenprüfung
Jaguar wird am 23. Juli 2024 ein Webcast für Investoren veranstalten, um Updates zu seinem Portfolio zur Unterstützung von Krebspatienten bereitzustellen.
- Clinically relevant signals observed in breast and respiratory cancer subgroups, which comprised over 75% of trial participants
- Positive signals improved over the initial 12-week phase of the study
- Crofelemer was well-tolerated with an adverse event profile similar to placebo
- Company plans to engage with FDA for potential pathway forward
- Jaguar to launch FDA-approved oral mucositis product Gelclair® in Q4 2024
- Phase 3 OnTarget trial did not meet its primary endpoint across all tumor types
- Study results did not achieve significance for all tumor types receiving various targeted therapies
- Full data analysis for the 12-week extension phase not yet completed
Initial results of unprecedented trial including 10 different tumor types indicate that OnTarget did not meet its primary endpoint across all tumor types. Trial did reveal clinically relevant signals for crofelemer in prespecified subgroups of patients with breast and respiratory cancer, including lung cancer.
Jaguar to host investor webcast Tuesday, July 23rd at 8:30 AM Eastern to provide updates on company's cancer supportive care portfolio, including participation from Jaguar scientific team, patient advocates, and leading oncology experts on cancer therapy-related diarrhea (CTD) and oral mucositis; Click here to register for webcast.
SAN FRANCISCO, CA / ACCESSWIRE / July 23, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced the results from its initial analysis of the pivotal Phase 3 OnTarget trial of crofelemer for prophylaxis of diarrhea in adult cancer patients with solid tumors receiving targeted therapy with or without standard chemotherapy. Crofelemer is an FDA-approved prescription drug for the symptomatic relief of diarrhea in adult HIV/AIDS patients receiving antiretroviral therapy. The initial results from the OnTarget study show that the multicenter, double-blind, placebo-controlled pivotal clinical trial did not meet its primary endpoint for the prespecified analysis of all tumor types in the trial.
"While the results of the OnTarget study did not achieve significance for all tumor types receiving various targeted therapies, I am pleased that the subgroup analyses show that crofelemer provides clinically meaningful improvement in the prespecified subgroups of breast and respiratory tumor patients. Clinical meaningfulness of these results is based on the information provided by solid tumor patients from a survey that informed us about the appropriate clinical study design and clinical endpoints, that are important to the patients in this prophylactic trial. We will continue to evaluate important OnTarget findings, with further analyses," said Pablo Okhuysen, MD, Professor of Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas, who is the Principal Investigator of the OnTarget clinical trial. "It is important to note that the prespecified secondary outcomes for this study were based on outcomes that were considered to be meaningful by patients experiencing diarrhea due to targeted therapy."
KEY TAKE-A-WAYS FROM ONTARGET TRIAL
Unprecedented OnTarget trial included patients with 10 different tumor types and 24 different targeted agents, with and without multiple standard cytotoxic chemotherapies.
Study did not meet prespecified analysis of primary endpoint for all tumor types.
Analysis did reveal clinically relevant signals for patients in the prespecified subgroups of breast and respiratory cancers, including lung cancer, who received targeted therapies. These subgroups of patients comprised over
75% of the patients in the trial.Breast and lung cancers are two of the three most common cancers, with patients often remaining on targeted therapy over prolonged periods.
A growing and urgent unmet medical need exists for novel non-opioid chronic agents to treat CTD.
Results indicate positive signals improved over the initial 12-week phase of study; data for additional 12-week extension phase yet to be analyzed.
Company expects to engage with FDA after full review of data.
The unprecedented OnTarget trial included patients with 10 different tumor types and 24 different targeted agents, with and without multiple standard cytotoxic chemotherapies. It consisted of two 12-week stages: a 12-week double-blind treatment phase followed by a 12-week double-blind extension phase. The prespecified primary endpoint for the trial was defined as reducing the average number of weekly loose and/or watery stools for all tumor types receiving various targeted therapies over the initial 12-week period of this prophylactic study. Analysis of data for the initial 12-week stage revealed clinically relevant signals for crofelemer over placebo in the prespecified subgroups of breast and respiratory cancer patients, who comprised over
"We believe the OnTarget trial, designed boldly to address a broad array of cancer patients undergoing therapy known to be associated with diarrhea, did not meet the primary endpoint given the heterogenous nature of the patients enrolled in the trial. Nevertheless, we are pleased that our preliminary analysis of the study data shows a clinically meaningful benefit in response to crofelemer in patients with breast and respiratory cancers, including lung cancer," said Lisa Conte, Founder, President, and Chief Executive Officer of Jaguar. "Breast and lung cancer are two of the top three most common cancer types, and treatment options for breast and lung cancer include the long-term use of targeted therapies that cause high incidences of diarrhea. We will continue to review data from prespecified and non-prespecified OnTarget subgroups and then engage in discussions with the U.S. Food and Drug Administration (FDA) to seek the most efficient pathway to bring crofelemer to these patients and address the important and debilitating side effect of cancer therapy-related diarrhea with the paradigm shifting mechanism of crofelemer. Patient dignity and the ability of patients to adhere with comfort to their cancer therapy is first and foremost in our ongoing development efforts."
Crofelemer was well tolerated in OnTarget, and the adverse event profile was similar to placebo. Most adverse events were related to the cancer therapy and/or the disease itself. The OnTarget findings are based on 287 patients representing all solid tumor types and 24 targeted agents, with or without cytotoxic chemotherapy. Included within the 287 enrolled patients were 37 respiratory cancer patients and 180 breast cancer patients or greater than
"Our deepest gratitude goes to the patients and investigators who participated in this study around the world. We are proud to have completed the first prophylactic, randomized, double-blind study including patient reported outcomes for prevention of cancer therapy-related diarrhea. The study prioritized standard of cancer care for study participants, with Jaguar's endorsement," Conte said. "As Jaguar continues the journey to bring crofelemer to people living with a cancer diagnosis, we remain fully committed to expanding our commercial footprint beyond HIV-related supportive care. In Q4 2024, we will launch the FDA-approved oral mucositis prescription product Gelclair® for the U.S. market. Oral mucositis is a dose-limiting side effect of cancer treatment, with more than one-third of patients discontinuing treatment because of the condition.1 Additionally, crofelemer is in multiple clinical investigations globally for the orphan indications of short bowel syndrome and microvillus inclusion disease - an ultrarare congenital diarrheal disorder - with proof-of-concept data targeted for end of 2024 and throughout 2025."
Participation Instructions for Webcast
When: Tuesday, July 23, 2024 at 8:30 AM Eastern Time
Participant Registration & Access Link: Click Here
Replay Instructions for Webcast
Replay of the webcast on the investor relations section of Jaguar's website: (click here)
About the Phase 3 OnTarget Clinical Trial
The multicenter double-blind, placebo-controlled OnTarget study is a first-of-its-kind prophylactic clinical trial with a primary endpoint based on patient-reported outcomes that address the highly neglected and unmet burden of cancer therapy-related diarrhea. The study evaluated the efficacy of crofelemer, a botanical drug that modulates intestinal chloride ion channels, for its ability to prevent or substantially reduce cancer therapy-related diarrhea over the 12-week treatment period, compared to placebo. The trial involved 10 different tumor types and 24 different targeted agents, with and without multiple standard cytotoxic chemotherapies. Patients then had the opportunity to continue in a blinded 12-week extension of their phase 1 therapy. A majority of the patients chose to continue.
About Crofelemer
Crofelemer is the only oral prescription drug approved under FDA botanical guidance. It is plant-based, extracted and purified from the red bark sap of the Croton lechleri tree in the Amazon rainforest. Jaguar family company Napo Pharmaceuticals has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for Indigenous communities.
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 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 it will conduct an investor webcast on July 23, 2024, Jaguar's expectation that it will complete the analysis of full data for the first and second 12-week periods and disclose the results in future presentations and publications, Jaguar's expectation that it will engage in discussions with the FDA to seek the most efficient pathway to bring crofelemer to cancer patients and address the side effect of CTD, Jaguar's expectation that it will launch Gelclair in the U.S. in Q4 2024, and Jaguar's expectation that proof-of-concept data from multiple clinical investigations of crofelemer for short bowel syndrome and microvillus inclusion disease will be available by the end of 2024 and throughout 2025. 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 Oncology Nursing Society (ONS): https://www.ons.org/pep/mucositis
Contact:
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SOURCE: Jaguar Health
View the original press release on accesswire.com
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