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Proof-of-Concept Results Show Jaguar Health's Crofelemer Reduced Total Parenteral Nutrition in Third Intestinal Failure Orphan Disease Patient

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Jaguar Health (NASDAQ:JAGX) announced positive proof-of-concept results for their drug crofelemer in treating a third intestinal failure patient. The novel liquid formulation demonstrated efficacy in reducing total parenteral nutrition (TPN) requirements in a second pediatric patient with short bowel syndrome (SBS-IF).

The results build on previously reported data showing crofelemer reduced TPN requirements by up to 27% in microvillus inclusion disease (MVID) patients and up to 12.5% in SBS-IF patients. Notably, when the first two patients were taken off crofelemer after 12 weeks of treatment, their symptoms worsened, leading to prompt reinstatement of the treatment.

The company is conducting multiple studies, including two independent proof-of-concept investigator-initiated trials (IITs) and two placebo-controlled Phase 2 studies. The Phase 2 study in pediatric MVID patients is expected to complete by mid-2026. Jaguar is actively seeking business development partnerships for licensing rights to develop and commercialize their intestinal failure products, aiming to generate non-dilutive funding.

[ "Crofelemer reduced TPN requirements by up to 27% in MVID patients and 12.5% in SBS-IF patients", "Second pediatric SBS-IF patient showed similar positive response for TPN reduction", "No safety issues reported at highest protocol-approved dose", "Results may support inclusion in EMA's PRIME program and FDA's Breakthrough Therapy program", "Data could support reimbursed early patient access in EU countries" ]

Jaguar Health (NASDAQ:JAGX) ha annunciato risultati positivi di proof-of-concept per il loro farmaco crofelemer nel trattamento di un terzo paziente con insufficienza intestinale. La nuova formulazione liquida ha dimostrato efficacia nel ridurre le necessità di nutrizione parenterale totale (TPN) in un secondo paziente pediatrico con sindrome da intestino corto (SBS-IF).

I risultati si basano su dati precedenti che mostrano come il crofelemer abbia ridotto le necessità di TPN fino al 27% nei pazienti con malattia da inclusione dei microvilli (MVID) e fino al 12,5% nei pazienti con SBS-IF. È importante notare che, quando i primi due pazienti sono stati sospesi dal trattamento con crofelemer dopo 12 settimane, i loro sintomi sono peggiorati, portando alla pronta ripresa della terapia.

L’azienda sta conducendo diversi studi, inclusi due trial indipendenti di proof-of-concept avviati da ricercatori (IIT) e due studi di Fase 2 controllati con placebo. Lo studio di Fase 2 su pazienti pediatrici con MVID dovrebbe concludersi entro la metà del 2026. Jaguar è attivamente alla ricerca di partnership di sviluppo commerciale per ottenere diritti di licenza per sviluppare e commercializzare i propri prodotti per l’insufficienza intestinale, con l’obiettivo di generare finanziamenti non diluitivi.

  • Il crofelemer ha ridotto le necessità di TPN fino al 27% nei pazienti MVID e al 12,5% nei pazienti SBS-IF
  • Il secondo paziente pediatrico con SBS-IF ha mostrato una risposta positiva simile nella riduzione della TPN
  • Non sono stati segnalati problemi di sicurezza alla dose più alta approvata dal protocollo
  • I risultati potrebbero supportare l’inclusione nel programma PRIME dell’EMA e nel programma Breakthrough Therapy della FDA
  • I dati potrebbero favorire l’accesso precoce rimborsato per i pazienti nei paesi UE

Jaguar Health (NASDAQ:JAGX) anunció resultados positivos de prueba de concepto para su medicamento crofelemer en el tratamiento de un tercer paciente con insuficiencia intestinal. La novedosa formulación líquida demostró eficacia en la reducción de los requerimientos de nutrición parenteral total (TPN) en un segundo paciente pediátrico con síndrome de intestino corto (SBS-IF).

Los resultados se basan en datos previos que mostraron que crofelemer redujo los requerimientos de TPN hasta en un 27% en pacientes con enfermedad de inclusión de microvellosidades (MVID) y hasta un 12,5% en pacientes con SBS-IF. Es importante destacar que, cuando los dos primeros pacientes dejaron de recibir crofelemer tras 12 semanas de tratamiento, sus síntomas empeoraron, lo que llevó a la pronta reinstauración del tratamiento.

La compañía está realizando múltiples estudios, incluyendo dos ensayos independientes de prueba de concepto iniciados por investigadores (IIT) y dos estudios controlados con placebo de Fase 2. Se espera que el estudio de Fase 2 en pacientes pediátricos con MVID finalice para mediados de 2026. Jaguar está activamente buscando asociaciones de desarrollo comercial para obtener derechos de licencia para desarrollar y comercializar sus productos para insuficiencia intestinal, con el objetivo de generar financiamiento no dilutivo.

  • Crofelemer redujo los requerimientos de TPN hasta en un 27% en pacientes con MVID y un 12,5% en pacientes con SBS-IF
  • El segundo paciente pediátrico con SBS-IF mostró una respuesta positiva similar en la reducción de TPN
  • No se reportaron problemas de seguridad en la dosis más alta aprobada por el protocolo
  • Los resultados podrían apoyar la inclusión en el programa PRIME de la EMA y en el programa Breakthrough Therapy de la FDA
  • Los datos podrían respaldar el acceso temprano reembolsado para pacientes en países de la UE

Jaguar Health (NASDAQ:JAGX)ëŠ� ì„� 번째 ìž� 기능 ë¶€ì � í™˜ìž ì¹˜ë£Œì—� 있어 약물 í¬ë¡œíŽ ëŸ¬ë¨¸ì˜ ê¸ì •ì ì¸ ê°œë… ì¦ëª… ê²°ê³¼ë¥� 발표했습니다. 새로ìš� ì•¡ìƒ ì œí˜•ì€ ë‹¨ìž¥ ì¦í›„êµ�(SBS-IF)ì� ê°€ì§� ë‘� 번째 소아 환ìžì� ì´� 비경êµ� ì˜ì–‘(TPN) 요구ëŸ� ê°ì†Œì—� 효과ë¥� ìž…ì¦í–ˆìŠµë‹ˆë‹¤.

ì� ê²°ê³¼ëŠ� ì´ì „ì—� ë³´ê³ ë� ë°ì´í„°ì— 기반하며, í¬ë¡œíŽ ëŸ¬ë¨¸ê°€ 미세융모 í¬í•¨ 질환(MVID) 환ìžì—서 최대 27%, SBS-IF 환ìžì—서 최대 12.5%까지 TPN ìš”êµ¬ëŸ‰ì„ ì¤„ì˜€ìŒì„ ë³´ì—¬ì¤ë‹ˆë‹�. 특히 최초 ë‘� 환ìžê°€ 12ì£� 치료 í›� í¬ë¡œíŽ ëŸ¬ë¨� 투여ë¥� ì¤‘ë‹¨í–ˆì„ ë•� ì¦ìƒì� ì•…í™”ë˜ì–´ ì¦‰ê° ì¹˜ë£Œê°€ 재개ë˜ì—ˆìŠµë‹ˆë‹�.

회사ëŠ� ë‘� ê±´ì˜ ë…립ì ì¸ 연구ìž� ì£¼ë„ ê°œë… ì¦ëª… 시험(IIT)ê³� ë‘� ê±´ì˜ ìœ„ì•½ 대ì¡� 2ìƒ� 연구ë¥� í¬í•¨í•� 다수ì� 연구ë¥� ì§„í–‰ 중입니다. 소아 MVID í™˜ìž ëŒ€ìƒ� 2ìƒ� 연구ëŠ� 2026ë…� 중반 완료ë� 예정입니ë‹�. JaguarëŠ� ìž� 기능 ë¶€ì � 제품ì� 개발 ë°� ìƒìš©í™”를 위한 ë¼ì´ì„ ìФ 권리ë¥� 확보하기 위해 사업 개발 파트너십ì� ì ê·¹ 모색 중ì´ë©�, 비í¬ì„성 ìžê¸ˆ 조달ì� 목표ë¡� 하고 있습니다.

  • í¬ë¡œíŽ ëŸ¬ë¨¸ëŠ” MVID 환ìžì—서 최대 27%, SBS-IF 환ìžì—서 12.5%까지 TPN ìš”êµ¬ëŸ‰ì„ ê°ì†Œì‹œì¼°ìŠµë‹ˆë‹�
  • ë‘� 번째 소아 SBS-IF 환ìžë� 유사í•� ê¸ì •ì � ë°˜ì‘ì� ë³´ì—¬ TPN ê°ì†Œì—� 성공했습니다
  • 프로토콜 ìŠ¹ì¸ ìµœê³  용량ì—서ë� 안전ì„� 문제 ë³´ê³  ì—†ìŒ
  • ê²°ê³¼ëŠ� EMAì� PRIME 프로그램 ë°� FDAì� Breakthrough Therapy 프로그램 í¬í•¨ì� ì§€ì›í•  ìˆ� 있습니다
  • ë°ì´í„°ëŠ” EU êµ­ê°€ì—서 환ìžì� 조기 유급 ì ‘ê·¼ì� ì§€ì›í•  ìˆ� 있습니다

Jaguar Health (NASDAQ:JAGX) a annoncé des résultats positifs de preuve de concept pour leur médicament crofelemer dans le traitement d’un troisième patient atteint d’insuffisance intestinale. La nouvelle formulation liquide a démontré son efficacité en réduisant les besoins en nutrition parentérale totale (NPT) chez un deuxième patient pédiatrique souffrant du syndrome de l’intestin court (SBS-IF).

Ces résultats s’appuient sur des données précédemment rapportées montrant que le crofelemer réduisait les besoins en NPT jusqu’� 27 % chez les patients atteints de maladie à inclusion microvillositaire (MVID) et jusqu’� 12,5 % chez les patients atteints de SBS-IF. Il est notable que, lorsque les deux premiers patients ont arrêté le crofelemer après 12 semaines de traitement, leurs symptômes se sont aggravés, entraînant une reprise rapide du traitement.

L’entreprise mène plusieurs études, dont deux essais indépendants de preuve de concept initiés par des investigateurs (IIT) et deux études de phase 2 contrôlées par placebo. L’étude de phase 2 chez les patients pédiatriques atteints de MVID devrait se terminer d’ici mi-2026. Jaguar recherche activement des partenariats de développement commercial pour obtenir les droits de licence afin de développer et commercialiser ses produits pour l’insuffisance intestinale, dans le but de générer des financements non dilutifs.

  • Le crofelemer a réduit les besoins en NPT jusqu’Ã� 27 % chez les patients MVID et 12,5 % chez les patients SBS-IF
  • Le deuxième patient pédiatrique SBS-IF a montré une réponse positive similaire pour la réduction de la NPT
  • Aucun problème de sécurité signalé à la dose la plus élevée approuvée par le protocole
  • Les résultats pourraient soutenir l’inclusion dans le programme PRIME de l’EMA et le programme Breakthrough Therapy de la FDA
  • Les données pourraient soutenir un accès précoce remboursé pour les patients dans les pays de l’UE

Jaguar Health (NASDAQ:JAGX) gab positive Proof-of-Concept-Ergebnisse für ihr Medikament Crofelemer bei der Behandlung eines dritten Patienten mit intestinalem Versagen bekannt. Die neuartige flüssige Formulierung zeigte Wirksamkeit bei der Reduzierung des gesamten parenteralen Ernährungsbedarfs (TPN) bei einem zweiten pädiatrischen Patienten mit Kurzdarmsyndrom (SBS-IF).

Die Ergebnisse bauen auf zuvor veröffentlichten Daten auf, die zeigten, dass Crofelemer den TPN-Bedarf bei Patienten mit Mikrovillus-Inklusionskrankheit (MVID) um bis zu 27% und bei SBS-IF-Patienten um bis zu 12,5% reduzierte. Bemerkenswert ist, dass sich die Symptome der ersten beiden Patienten verschlechterten, als sie nach 12 Wochen Behandlung von Crofelemer abgesetzt wurden, was zu einer schnellen Wiedereinsetzung der Therapie führte.

Das Unternehmen führt mehrere Studien durch, darunter zwei unabhängige Proof-of-Concept-Investigator-initiierte Studien (IITs) und zwei placebokontrollierte Phase-2-Studien. Die Phase-2-Studie bei pädiatrischen MVID-Patienten soll bis Mitte 2026 abgeschlossen sein. Jaguar sucht aktiv Geschäftsentwicklungspartnerschaften zur Lizenzierung der Rechte zur Entwicklung und Vermarktung ihrer Produkte bei intestinalem Versagen, mit dem Ziel, nicht verwässernde Finanzierung zu generieren.

  • Crofelemer reduzierte den TPN-Bedarf bei MVID-Patienten um bis zu 27% und bei SBS-IF-Patienten um 12,5%
  • Der zweite pädiatrische SBS-IF-Patient zeigte eine ähnliche positive Reaktion bei der TPN-Reduktion
  • Keine Sicherheitsprobleme bei der höchsten vom Protokoll genehmigten Dosis gemeldet
  • Die Ergebnisse könnten die Aufnahme in das PRIME-Programm der EMA und das Breakthrough-Therapy-Programm der FDA unterstützen
  • Daten könnten eine erstattete frühzeitige Patientenversorgung in EU-Ländern unterstützen
Positive
  • None.
Negative
  • Patients' symptoms worsened when taken off crofelemer treatment
  • Phase 2 study completion not expected until mid-2026
  • Company seeking partnerships due to need for non-dilutive funding

Insights

Crofelemer shows promising TPN reduction in rare intestinal disorders, creating potential value for JAGX despite early-stage results.

Jaguar Health's press release highlights proof-of-concept results showing their drug crofelemer reduced total parenteral nutrition (TPN) requirements in a third intestinal failure patient - specifically a second pediatric patient with short bowel syndrome (SBS-IF). This follows previously reported reductions of 27% in a microvillus inclusion disease (MVID) patient and 12.5% in another SBS-IF patient.

The clinical significance here is substantial. Both MVID and SBS-IF are rare intestinal failure conditions requiring long-term TPN, which carries serious complications including liver damage, infections, and cognitive deficits. Any therapy reducing TPN dependency addresses a critical unmet need.

Two compelling data points strengthen the evidence for crofelemer's effectiveness: First, patients who discontinued crofelemer after 12 weeks (per protocol) experienced symptom worsening and had to restart treatment prematurely. Second, even at the highest protocol-approved dose, no safety issues were reported in the SBS-IF patient.

The company is pursuing a strategic approach with these ultra-rare indications. Given MVID's extremely small patient population, even limited positive data might support expedited regulatory pathways through the EMA's PRIME program or FDA's Breakthrough Therapy designation. The company explicitly plans to leverage these preliminary results to seek business development partnerships and non-dilutive funding rather than pursuing costly later-stage trials independently.

While promising, it's important to recognize these are early results from a small, open-label, non-randomized investigator-initiated trial. The company's controlled Phase 2 studies won't complete until mid-2026. However, for ultra-rare diseases like MVID with no approved treatments, even limited positive evidence can potentially support accelerated approval pathways.

As recently , initial proof-of-concept results from this ongoing investigator-initiated trial (IIT) show crofelemer reduced the required total parenteral nutrition in the first participating microvillus inclusion disease (MVID) patient by up to 27% and in the first participating short bowel syndrome patient by up to 12.5%

The first two patients in this IIT were taken off crofelemer after 12 weeks of treatment for a period intended to last 30 days, per the study protocol, but were promptly placed back on daily crofelemer treatment because their symptoms worsened

Company strategy: Seek business development partnerships for license to develop and commercialize Jaguar's intestinal failure products, resulting in non-dilutive funding for Jaguar

SAN FRANCISCO, CA / / June 30, 2025 / () (Jaguar) family companies (Napo) and today announced that initial proof-of-concept results show that a novel liquid formulation of crofelemer reduced the required total parenteral nutrition (TPN) and supplementary intravenous fluids in a third intestinal failure patient. This is the second pediatric patient with intestinal failure due to the orphan disease short bowel syndrome (SBS-IF) who was treated with crofelemer. To date, three patients with intestinal failure due to SBS-IF or microvillus inclusion disease (MVID) have been treated with crofelemer in this exploratory, single-arm open label non-randomized IIT in Abu Dhabi.

As , and as presented April 26, 2025 at the , initial proof-of-concept results from this study show that crofelemer, Jaguar's novel plant-based anti-secretory prescription drug, reduced the required TPN and supplementary intravenous fluids in the first participating MVID patient by up to 27% and in the first participating SBS-IF patient by up to 12.5%. In addition, this data showed that crofelemer reduced stool volume output and/or frequency of watery stools, and increased urine output - an indicator of improved nutrient oral absorption.

"We're very pleased to report that the second pediatric SBS-IF patient participating in this IIT exhibited a similar response for TPN reduction, further exemplifying that crofelemer's paradigm-shifting antisecretory mechanism of action may have the potential to provide a novel therapeutic option to modify disease progression due to the reductions in TPN and associated comorbidities in MVID and SBS-IF patients and improve their quality of life," said Lisa Conte, Jaguar's Founder and CEO. "This SBS-IF patient was administered the highest dose of crofelemer provided for in the approved protocol for the IIT, with no resulting safety issues."

Per the IIT protocol, as , the initial pediatric MVID patient participating in the study was taken off crofelemer after 12 weeks of treatment for an intended period of 30 days. However, after just 8 days, the patient's parents requested reinitiation of crofelemer dosing, as the patient's symptoms worsened - evidenced by increased stool output and decreased urine output - and the patient was restarted on daily treatment with crofelemer. The initial pediatric SBS-IF patient participating in the study also had crofelemer withdrawn per the protocol after 12 weeks. This patient then exhibited a relapse of symptoms and was put back on daily treatment with crofelemer, and has since been maintaining a significant TPN reduction. Jaguar plans to continue supplying crofelemer to Dr. Mohamad Miqdady, the principal investigator for this IIT, for the patients participating in this study for as long as Dr. Miqdady feels is medically necessary.

Dr. Miqdady has submitted initial proof-of-concept data from the ongoing IIT in Abu Dhabi for all three above-referenced patients to a major international pediatric gastroenterological conference for consideration for presentation.

Jaguar, through Jaguar family companies Napo and Napo Therapeutics, is currently supporting two independent proof-of-concept IITs, and conducting two placebo-controlled Phase 2 studies, of crofelemer in patients with intestinal failure due to MVID and SBS-IF in the United States, European Union, and/or Middle East/North Africa regions.

Completion of Napo's randomized double-blind, placebo-controlled Phase 2 study of crofelemer in pediatric MVID patients is expected in mid-2026 as planned.

"Our strategy is to seek business development partnerships for license rights for development and commercialization of Jaguar's intestinal failure products - with the goal of generating non-dilutive funding for Jaguar," said Conte. "Given the ultrarare nature of MVID, and the groundbreaking initial proof-of-concept results from the ongoing IIT in Abu Dhabi, even a small number of MVID patients showing benefit with crofelemer may allow Napo to explore pathways for expedited regulatory approval."

Based on the initial findings of the ongoing IIT in Abu Dhabi, crofelemer's paradigm-shifting antisecretory mechanism of action appears to have the potential to provide a novel therapeutic option to reduce TPN and associated complications, including liver, renal, and cognitive deficits, as well as infections from IV infusion, in patients with intestinal failure due to MVID and short bowel syndrome. The observed groundbreaking TPN reduction is particularly compelling for MVID, an ultrarare pediatric disease characterized by severe diarrhea and malabsorption that requires intensive parenteral support for nutritional and fluid management and for which no approved drug treatments exist, or any potential approach to reduce TPN.

The initial proof-of-concept data in MVID supports crofelemer's potential inclusion in the European Medicines Agency's (EMA) program that may accelerate regulatory approval pathways in the EU for this indication. This data may also support qualification of crofelemer for the FDA's program for expedited regulatory approval in the US. Additional proof-of-concept results from IITs are expected throughout 2025 and will provide additional preliminary data on the safety and potential effectiveness of crofelemer for these highly unmet clinical needs. In accordance with the guidelines of specific EU countries, published data from clinical investigations in MVID and SBS-IF could support reimbursed early patient access to crofelemer for these debilitating conditions.

The IIT in Abu Dhabi is being conducted by Dr. Miqdady at (SKMC), a flagship tertiary hospital in the United Arab Emirates and the largest teaching medical center in Abu Dhabi. Dr. Miqdady, a recognized leader in pediatric gastroenterology, serves as the Chief of Pediatric Gastroenterology, Hepatology and Nutrition at SKMC. He is an American board-certified pediatric GI, hepatology and nutrition professor at in Abu Dhabi, and also serves as a member of Napo's Scientific Advisory Board. Dr. Miqdady completed his Fellowship in Pediatric Gastroenterology at Baylor College of Medicine and Texas Children's Hospital in Houston.

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 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 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 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 (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.

For more information about:

Jaguar Health, visit

Napo Pharmaceuticals, visit Napo Therapeutics, visit Magdalena Biosciences, visit

Visit the Make Cancer Less Shitty patient advocacy program on , , &

Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that completion of Napo's Phase 2 study of crofelemer in pediatric MVID patients will occur mid-2026, Jaguar's expectation that its strategy of seeking business development partnerships for license rights for development and commercialization of Jaguar's intestinal failure products may support generation of non-dilutive funding for Jaguar, Jaguar's expectation that even a small number of MVID patients showing benefit with crofelemer may allow Napo to explore pathways for expedited regulatory approval of crofelemer for MVID, Jaguar's expectation that crofelemer's mechanism of action may have the potential to provide a novel therapeutic option to reduce TPN and associated complications, including liver, renal, and cognitive deficits, as well as infections from IV infusion, in pediatric MVID and SBS-IF patients, Jaguar's expectation that proof-of-concept data in MVID may support crofelemer's potential inclusion in the EMA's PRIME program for expediated and assisted regulatory approval and in the FDA's Breakthrough Therapy program for expedited regulatory approval in the US, Jaguar's expectation that additional proof-of-concept results from IITs will be available throughout 2025, and Jaguar's expectation that published data from clinical investigations in MVID and SBS-IF could support reimbursed early patient access to crofelemer for MVID and SBS-IF. 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:

[email protected]

Jaguar-JAGX

SOURCE: Jaguar Health, Inc.



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FAQ

What were the key results of Jaguar Health's (JAGX) crofelemer trial in intestinal failure patients?

The trial showed crofelemer reduced total parenteral nutrition (TPN) requirements by up to 27% in MVID patients and up to 12.5% in SBS-IF patients, with similar results in a third patient.

When will Jaguar Health complete its Phase 2 study for crofelemer in MVID patients?

The randomized double-blind, placebo-controlled Phase 2 study is expected to complete in mid-2026.

What happened when patients stopped taking crofelemer in the trial?

When patients were taken off crofelemer after 12 weeks, their symptoms worsened, leading to early reinstatement of the treatment before the planned 30-day withdrawal period.

What is Jaguar Health's business strategy for crofelemer?

Jaguar Health is seeking business development partnerships for licensing rights to develop and commercialize their intestinal failure products, aiming to generate non-dilutive funding.

What regulatory pathways is Jaguar Health pursuing for crofelemer?

The company is pursuing potential inclusion in the EMA's PRIME program and the FDA's Breakthrough Therapy program for expedited regulatory approval in the EU and US respectively.
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