Significant Positive Results with Jaguar Health's Crofelemer for Chronic Refractory Diarrhea in IBS-D, Presented at American College of Gastroenterology Annual Meeting
Jaguar Health (NASDAQ:JAGX) announced positive results from two independent investigator-initiated studies of crofelemer, presented at the American College of Gastroenterology Annual Scientific Meeting. The first study showed that crofelemer significantly decreased stool consistency and abdominal pain in patients with functional diarrhea. The second study demonstrated that 58.8% of patients with chronic idiopathic diarrhea improved within a 4-week treatment period. Both studies suggest crofelemer's effectiveness in treating different forms of chronic diarrhea, with minimal side effects. The drug has also shown promise in previous Phase 2 trials for IBS-D and achieved statistical significance in breast cancer patients from the Phase 3 OnTarget trial.
Jaguar Health (NASDAQ:JAGX) ha annunciato risultati positivi da due studi indipendenti avviati dai ricercatori riguardanti il crofelemere, presentati alla Riunione Scientifica Annuale del Collegio Americano di Gastroenterologia. Il primo studio ha dimostrato che il crofelemere ha significativamente ridotto la consistenza delle feci e il dolore addominale nei pazienti con diarrea funzionale. Il secondo studio ha mostrato che il 58,8% dei pazienti con diarrea idiopatica cronica ha mostrato miglioramenti nel corso di un periodo di trattamento di 4 settimane. Entrambi gli studi suggeriscono l'efficacia del crofelemere nel trattamento di diverse forme di diarrea cronica, con effetti collaterali minimi. Il farmaco ha anche mostrato risultati promissori in precedenti studi di Fase 2 per la IBS-D e ha raggiunto significatività statistica nei pazienti con cancro al seno dallo studio di Fase 3 OnTarget.
Jaguar Health (NASDAQ:JAGX) anunció resultados positivos de dos estudios independientes iniciados por investigadores sobre el crofelemere, presentados en la Reunión Científica Anual del Colegio Americano de Gastroenterología. El primer estudio mostró que el crofelemere redujo significativamente la consistencia de las heces y el dolor abdominal en pacientes con diarrea funcional. El segundo estudio demostró que el 58.8% de los pacientes con diarrea idiopática crónica mejoraron durante un período de tratamiento de 4 semanas. Ambos estudios sugieren la efectividad del crofelemere en el tratamiento de diferentes formas de diarrea crónica, con efectos secundarios mínimos. El medicamento también ha mostrado promesas en ensayos previos de Fase 2 para la IBS-D y alcanzó significancia estadística en pacientes con cáncer de mama del ensayo de Fase 3 OnTarget.
재규어 헬스(NASDAQ:JAGX)는 크로페레머에 대한 두 개의 독립적인 연구에서 긍정적인 결과를 발표했으며, 이는 미국 소화기학회 연례 과학 회의에서 발표되었습니다. 첫 번째 연구에서는 크로페레머가 기능성 설사를 앓고 있는 환자들의 대변 일관성과 복통을 유의미하게 감소시켰다고 밝혔습니다. 두 번째 연구에서는 만성 특발성 설사를 앓고 있는 환자의 58.8%가 4주 치료 기간 동안 개선되었다고 보여주었습니다. 두 연구 모두 크로페레머의 만성 설사의 다양한 형태 치료에 대한 효과와 최소한의 부작용을 제안합니다. 이 약물은 또한 IBS-D에 대한 이전의 2상 시험에서 유망한 결과를 보였으며, 3상 OnTarget 시험에서 유방암 환자들 중 통계적 유의미성을 달성했습니다.
Jaguar Health (NASDAQ:JAGX) a annoncé des résultats positifs de deux études indépendantes initiées par des chercheurs concernant le crofelemère, présentés lors de la Réunion Scientifique Annuelle du Collège Américain de Gastroentérologie. La première étude a montré que le crofelemère réduisait significativement la consistance des selles et la douleur abdominale chez les patients souffrant de diarrhée fonctionnelle. La deuxième étude a démontré que 58,8 % des patients atteints de diarrhée idiopathique chronique s'étaient améliorés au cours d'une période de traitement de 4 semaines. Les deux études suggèrent l'efficacité du crofelemère dans le traitement de différentes formes de diarrhée chronique, avec des effets secondaires minimes. Le médicament a également montré des résultats prometteurs dans des essais précédents de Phase 2 pour le SII-D et a atteint une signification statistique chez les patientes atteintes de cancer du sein dans l'essai de Phase 3 OnTarget.
Jaguar Health (NASDAQ:JAGX) gab positive Ergebnisse aus zwei unabhängigen, von Forschern initiierten Studien zu Crofelemmer bekannt, die auf dem Jahreswissenschaftlichen Treffen des American College of Gastroenterology präsentiert wurden. Die erste Studie zeigte, dass Crofelemmer die Stuhlkonsistenz und Bauchschmerzen signifikant reduzierte bei Patienten mit funktioneller Diarrhoe. Die zweite Studie zeigte, dass 58,8% der Patienten mit chronischer idiopathischer Diarrhoe sich innerhalb eines vierwöchigen Behandlungszeitraums verbesserten. Beide Studien deuten auf die Wirksamkeit von Crofelemmer bei der Behandlung verschiedener Formen chronischer Diarrhoe hin, mit minimalen Nebenwirkungen. Das Medikament hat auch in früheren Phase-2-Studien zur IBS-D vielversprechende Ergebnisse gezeigt und erreichte statistische Signifikanz bei Brustkrebspatienten in der Phase-3 OnTarget-Studie.
- 58.8% of patients with chronic idiopathic diarrhea showed improvement within 4 weeks
- Significant reduction in stool consistency and abdominal pain in functional diarrhea patients
- Demonstrated clinical effectiveness across multiple gastroenterological conditions
- Achieved statistical significance in breast cancer subgroup from Phase 3 OnTarget trial
- Small study size (17 patients) in functional diarrhea trial requires larger trials for validation
Insights
The clinical data for crofelemer in treating functional diarrhea and chronic idiopathic diarrhea shows promising results. In the functional diarrhea study, the drug demonstrated significant improvement in stool consistency without causing constipation - a common side effect of other treatments. The second study showed
Key highlights include:
- Positive response in both investigator-initiated studies
- Statistical significance achieved in breast cancer subgroup from Phase 3 OnTarget trial
- Market potential is substantial with
10-15% of US population having IBS, affecting twice as many women as men
It is estimated that 10
SAN FRANCISCO, CA / ACCESSWIRE / October 29, 2024 / Jaguar Health, Inc.(NASDAQ:JAGX) ("Jaguar") family company Napo Pharmaceuticals ("Napo") today announced that the abstracts are now available for two independent investigator-initiated studies of crofelemer, Napo's novel, plant-based oral prescription drug, that show a benefit in patients with chronic refractory diarrhea and are the subject of poster presentations taking place today, October 29, 2024, at the American College of Gastroenterology Annual Scientific Meeting (ACG 2024) in Philadelphia, Pennsylvania. Descriptions of both studies appear below, along with a link to the virtual ACG 2024 ePoster Hall page for each study - which display the poster for each study and provide a short audio presentation of the posters.
"We are very excited that crofelemer continues to demonstrate clinical robustness in responder analysis trials for multiple gastroenterological conditions - including functional diarrhea and chronic idiopathic diarrhea. We are inspired to address the unmet needs, unmet symptom management, and patient comfort in these populations, which are often considered subgroups of diarrhea-predominant irritable bowel syndrome (IBS-D)," commented Lisa Conte, President and CEO of Jaguar.
Crofelemer has been the subject of two previously presented Phase 2 trials in IBS-D. Additionally, as announced, the recently completed analysis of the prespecified subgroup of adult patients with breast cancer from our Phase 3 OnTarget trial of crofelemer for cancer therapy-related diarrhea indicate that crofelemer achieved statistical significance in this subgroup. The breast cancer results from OnTarget are also a responder analysis, and this data has been submitted by the study's primary investigators to a relevant oncology conference for consideration for a presentation.
Study: Pilot Study of Crofelemer for Functional Diarrhea
Link to Study Poster & Audio Presentation: Click Here
Crofelemer significantly decreased stool consistency and abdominal pain without significant side effects, including constipation, in this small crossover study of 17 patients with functional diarrhea. The study showed that crofelemer may be a particularly useful option in those patients without a significant pain component to their symptoms, and it may be safe and effective in functional diarrhea, particularly given that its mechanism of action is not constipating. Larger trials are needed to more thoroughly assess safety and longer-term efficacy of crofelemer in functional diarrhea. Judy Nee, MD, was the principal investigator for the study. Dr. Nee is a gastroenterologist at Beth Israel Deaconess Medical Center and an assistant professor at Harvard Medical School. She serves as co-director of the GI Motility Lab at Beth Israel, and specializes in GI motility disorders and functional GI diseases such as IBS, chronic diarrhea, and constipation, as well as movement disorders of the esophagus.
Functional diarrhea, defined as chronic diarrhea for more than 6 months, is a common diagnosis without effective treatments. It is a functional gastrointestinal disorder, meaning it occurs without any other known signs of disease, injury, or structural problem. Patients participating in the study self-reported their daily overall stool consistency based on the Bristol Stool Form Scale (BSFS) and number of loose/watery bowel movements, together with their score for their worst abdominal pain, the score for their abdominal discomfort, and any bloating episodes. The study protocol defined a stool consistency endpoint responder as a patient having ≤
Study: Crofelemer Improves Symptoms of Chronic Idiopathic Diarrhea
Link to Study Poster & Audio Presentation: Click Here
Chronic idiopathic diarrhea is a common complaint of patients presenting to family practitioners and internists, and is one of the most common reasons for referral to gastroenterologists. Despite significant advances in diagnostics, no organic etiology can be determined in a sizable proportion of patients suffering from chronic diarrhea, and there are currently no FDA-approved medications for chronic idiopathic diarrhea. It is estimated that the prevalence of chronic idiopathic diarrhea in developed countries (including the U.S.) is approximately 3
The study prospectively recruited patients with chronic idiopathic diarrhea defined as 3 non-bloody loose/watery stools per day or more than 20 non-bloody loose/watery stools per week for ≥ 4 weeks and a BSFS score of 6/7 for >
"According to the American College of Gastroenterology, scientific tests show that about
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. 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 the expectation that crofelemer may be a particularly useful option in functional diarrhea patients without a significant pain component to their symptoms and that it may be safe and effective in functional diarrhea, and the expectation that crofelemer will continue to be investigated for the treatment and management of chronic refractory diarrhea in patients with IBS-D. 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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