U.S. Investigator-Initiated Trial (IIT) to Evaluate Jaguar Health’s Crofelemer for Short Bowel Syndrome with Intestinal Failure (SBS-IF) Begins
Jaguar Health (NASDAQ:JAGX) announced the commencement of a U.S. Investigator-Initiated Trial (IIT) to evaluate crofelemer, their plant-based anti-diarrheal drug, for Short Bowel Syndrome with Intestinal Failure (SBS-IF). This study is part of five clinical efforts, including three IIT proof-of-concept studies and two Phase 2 studies across US, EU, and MENA regions.
The trials will evaluate a novel powder formulation of crofelemer for oral solution, with patient dosing expected throughout December 2024 and Q1 2025. Initial IIT proof-of-concept results could be available in Q2 2025. Notably, crofelemer has received Orphan Drug Designation from both FDA and European Medicines Agency for SBS-IF and Microvillus Inclusion Disease (MVID).
Jaguar Health (NASDAQ:JAGX) ha annunciato l'inizio di una sperimentazione clinica avviata da investigatori (IIT) negli Stati Uniti per valutare il crofelemer, il loro farmaco anti-diarroico di origine vegetale, per la Sindrome dell'Intestino Corto con Insufficienza Intestinale (SBS-IF). Questo studio fa parte di cinque sforzi clinici, tra cui tre studi di fattibilità IIT e due studi di Fase 2 nelle regioni degli Stati Uniti, dell'UE e MENA.
Le prove valuteranno una nuova formulazione in polvere di crofelemer per soluzione orale, con dosaggi ai pazienti previsti per tutto dicembre 2024 e il primo trimestre del 2025. I risultati iniziali della prova di fattibilità IIT potrebbero essere disponibili nel secondo trimestre del 2025. È importante notare che il crofelemer ha ricevuto la designazione di Farmaco Orfano sia dalla FDA che dall'Agenzia Europea per i Medicinali per SBS-IF e la Malattia da Inclusione Microvillus (MVID).
Jaguar Health (NASDAQ:JAGX) anunció el inicio de un Ensayo Clínico Iniciado por Investigadores (IIT) en EE. UU. para evaluar el crofelemer, su medicamento anti-diarreico de origen vegetal, para el Síndrome del Intestino Corto con Fallo Intestinal (SBS-IF). Este estudio es parte de cinco esfuerzos clínicos, que incluyen tres estudios de prueba de concepto IIT y dos estudios de Fase 2 en las regiones de EE. UU., UE y MENA.
Los ensayos evaluarán una nueva formulación en polvo de crofelemer para solución oral, con la dosificación en pacientes prevista para todo diciembre de 2024 y el primer trimestre de 2025. Los resultados iniciales de la prueba de concepto IIT podrían estar disponibles en el segundo trimestre de 2025. Cabe destacar que el crofelemer ha recibido la Designación de Medicamento Huérfano tanto de la FDA como de la Agencia Europea de Medicamentos para SBS-IF y la Enfermedad de Inclusión Microvillus (MVID).
재규어 헬스 (NASDAQ:JAGX)는 미국에서 연구자 주도 시험(IIT)을 시작하여 식물성 항설사제인 크로펠레머(crofelemer)를 단장 증후군 및 장실패(SBS-IF)를 평가한다고 발표했습니다. 이 연구는 세 가지 IIT 개념 증명 연구와 미국, 유럽 연합 및 MENA 지역에서의 두 개의 2상 연구를 포함한 다섯 개의 임상 시험의 일환입니다.
시험은 경구 용액을 위한 새로운 분말 형태의 크로펠레머를 평가하며, 환자 복용은 2024년 12월과 2025년 1분기 동안 진행될 것으로 예상됩니다. 초기 IIT 개념 증명 결과는 2025년 2분기에 제공될 수 있습니다. 특히, 크로펠레머는 SBS-IF 및 미세융모 포함 질환(MVID)에 대해 FDA와 유럽 의약품청에서 각각 희귀의약품으로 지정되었습니다.
Jaguar Health (NASDAQ:JAGX) a annoncé le lancement d'un essai clinique initié par des investigateurs (IIT) aux États-Unis pour évaluer le crofelemer, leur médicament anti-diarrhéique d'origine végétale, pour le syndrome de l'intestin court avec insuffisance intestinale (SBS-IF). Cette étude fait partie de cinq efforts cliniques, y compris trois études de preuve de concept IIT et deux études de phase 2 dans les régions des États-Unis, de l'UE et de la MENA.
Les essais évalueront une nouvelle formulation en poudre de crofelemer pour solution orale, avec une administration prévue aux patients tout au long de décembre 2024 et du premier trimestre 2025. Les résultats initiaux des études de preuve de concept IIT pourraient être disponibles au deuxième trimestre 2025. Il est à noter que le crofelemer a reçu la désignation de médicament orphelin tant par la FDA que par l'Agence européenne des médicaments pour le SBS-IF et la maladie d'inclusion microvillus (MVID).
Jaguar Health (NASDAQ:JAGX) gab bekannt, dass eine von Forschern initiierte klinische Studie (IIT) in den USA zur Evaluierung von Crofelemer, ihrem pflanzenbasierten Antidiarrhoikum, bei Kurzdarmsyndrom mit intestinalem Versagen (SBS-IF) beginnt. Diese Studie ist Teil von fünf klinischen Bemühungen, darunter drei IIT-Fachstudien und zwei Phase-2-Studien in den USA, der EU und der MENA-Region.
Die Studien werden eine neuartige Pulverformulierung von Crofelemer für die orale Lösung bewerten, wobei die Dosierung für Patienten voraussichtlich im Dezember 2024 und im ersten Quartal 2025 erfolgen wird. Erste Ergebnisse der IIT-Fachstudien könnten im zweiten Quartal 2025 verfügbar sein. Bemerkenswert ist, dass Crofelemer von der FDA und der Europäischen Arzneimittelagentur sowohl für SBS-IF als auch für die Mikroviilus-Inklusionskrankheit (MVID) als Orphan Drug bezeichnet wurde.
- FDA and European Medicines Agency granted Orphan Drug Designation for both SBS-IF and MVID indications
- Multiple concurrent clinical trials (5) across different regions indicate broad development strategy
- Potential for early patient access and reimbursement in specific EU countries based on clinical investigation data
- Results not expected until Q2 2025
- New powder formulation differs from currently FDA-approved oral formulation, requiring separate approval process
Insights
This clinical trial initiative represents a significant development in addressing rare gastrointestinal disorders. The multi-pronged approach with five concurrent clinical efforts - including three IIT proof-of-concept studies and two Phase 2 studies - demonstrates a comprehensive strategy to evaluate crofelemer's efficacy. The novel powder formulation for oral solution marks an important differentiation from the existing HIV/AIDS formulation.
The potential for early patient access in EU countries based on clinical investigation data could accelerate market entry. The focus on both SBS-IF and MVID addresses significant unmet medical needs, particularly considering the current reliance on intensive parenteral nutrition. The inclusion of quality-of-life assessments in Phase 2 studies could provide valuable data for reimbursement discussions and market access strategies.
For a micro-cap company with
The Q2 2025 timeline for potential proof-of-concept results provides a clear catalyst for investors to monitor. Early patient access in EU countries could accelerate revenue generation ahead of full approval. However, investors should note that clinical development in rare diseases, while potentially lucrative, requires significant capital investment which may necessitate future financing given the company's current market cap.
The study is one of five clinical efforts - three IIT proof-of-concept studies and two Phase 2 studies - of crofelemer for the rare disease indications of SBS-IF and/or microvillus inclusion disease (MVID), an ultrarare congenital diarrheal disorder, in the US, EU, and/or Middle East/North Africa (MENA) regions; availability of IIT proof-of-concept results potentially in Q2 2025
Crofelemer, Jaguar's novel plant-based prescription drug, has been granted Orphan Drug Designation by the FDA and the European Medicines Agency for both SBS-IF and MVID
SAN FRANCISCO, CA / ACCESSWIRE / December 6, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that an independent IIT in the U.S. to evaluate the efficacy and safety of crofelemer, Jaguar's novel plant-based anti-diarrheal prescription drug, for the rare disease indication of short bowel syndrome with intestinal failure (SBS-IF) in adults has begun. An overview of the study can be viewed on the ClinicalTrials.gov website.
Lisa Conte, Jaguar's founder, president, and CEO, said, "This study is one of five clinical efforts - three IIT proof-of-concept studies and two Phase 2 studies - of crofelemer for the rare disease indications of SBS-IF and/or MVID in the US, European Union, and/or MENA regions. These studies are evaluating a novel powder formulation of crofelemer for oral solution - which is different from the FDA-approved oral formulation of crofelemer available for people living with HIV/AIDS. Dosing of the first patient in each of these five studies is expected to occur throughout December 2024 and Q1 2025, with availability of IIT proof-of-concept results potentially in Q2 2025. In accordance with the guidelines of specific EU countries, published data from clinical investigations in SBS-IF and MVID could support reimbursed early patient access to crofelemer for these debilitating conditions in those countries."
"SBS-IF and MVID, rare and severe diseases requiring intensive parenteral nutrition (PN) and support, significantly impact the quality of life of both patients and their caregivers," Conte said. "We plan to assess the quality-of-life impact on patients and caregivers as part of both the above-referenced Phase 2 studies."
Some SBS patients are subject to intestinal failure, often requiring PN up to seven days a week. Intestinal failure is associated with significant morbidity and mortality; and high medical expenses associated with PN and coincident complications. SBS patients with intestinal failure also have severe chronic diarrhea, and the associated sequelae, including significant dehydration, metabolic acidosis or alkalosis and malnutrition, and other secondary symptoms. These symptoms may emerge at any time, and many times become life-threatening.
As a congenital diarrheal disorder, MVID is more prevalent in cultures with consanguineous marriage customs. Hence, the importance of the company's relationships with health care professionals in the MENA region, which support and are reflected in the recruiting geography of the trials.
Crofelemer has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for SBS-IF and MVID.
About Crofelemer
Crofelemer is a novel, oral plant-based prescription medicine purified from the red bark sap, also referred to as "dragon's blood," of the Croton lechleri tree in the Amazon Rainforest. Napo 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
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Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that dosing of the first patient in three IITs and two Phase 2 studies of crofelemer will occur throughout December 2024 and Q1 2025, Jaguar's expectation that availability of IIT proof-of-concept results of crofelemer in SBS-IF and/or MVID may potentially occur in Q2 2025, Jaguar's expectation that, in accordance with the guidelines of specific EU countries, published data from clinical investigations could support early patient access to crofelemer for SBS-IF or MVID in these countries, and Jaguar's expectation that it will assess the quality-of-life impact of SBS-IF and/or MVID on patients and caregivers as part of both Phase 2 studies of crofelemer. 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.
Contact:
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SOURCE: Jaguar Health, Inc.
View the original press release on accesswire.com
FAQ
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