Jaguar Health’s subsidiary, Napo Pharmaceuticals, announced the launch of an independent investigator-led trial in the United States to assess crofelemer’s efficacy and safety for treating short bowel syndrome with intestinal failure (SBS-IF) in adults. This study’s details are available on ClinicalTrials.gov.
According to Lisa Conte, founder, president, and CEO of Jaguar Health, “The trial is part of five ongoing clinical initiatives – comprising three proof-of-concept IITs and two phase 2 studies – targeting rare conditions such as SBS-IF and/or MVID across the US, EU, and MENA regions. These trials are focusing on a new powdered crofelemer oral solution, distinct from the currently FDA-approved form for HIV/AIDS patients. Expecting patient enrollment by late 2024 to early 2025, with initial results anticipated in Q2 2025, these studies might facilitate early access under certain EU regulations due to published outcomes about SBS-IF and MVID.”
Conte noted, “SBS-IF and MVID are challenging disorders entailing substantial reliance on parenteral nutrition (PN), impacting patients’ and caregivers’ lives profoundly. We aim to evaluate their quality-of-life changes within the ongoing phase 2 trials.”
Many SBS patients endure intestinal failure, often necessitating weekly PN, posing significant health risks and increasing healthcare expenditures. The disorder results in grave chronic diarrhea and various complications like dehydration and metabolic imbalances, potentially life-threatening.
Recognized as a congenital diarrheal disorder, MVID frequently appears in cultures with consanguineous marriage practices, underscoring the importance of Jaguar Health’s collaboration with healthcare professionals in the MENA region, also reflected in the trial’s recruiting scopes.
Crofelemer holds the Orphan Drug Designation from both the US FDA and European Medicines Agency for SBS-IF and MVID treatments.
Sustainably harvested from the Amazon Rainforest’s Croton lechleri tree, known colloquially as “dragon’s blood,” crofelemer represents a novel oral plant-derived pharmaceutical. Napo has implemented a responsible harvesting program ensuring quality and ecological conservation while supporting indigenous communities.
Jaguar Health, an innovative pharmaceutical company, develops plant-based medicines for gastrointestinal disorders like overactive bowel, addressing symptoms such as persistent diarrhea and abdominal discomfort, through sustainable practices derived from rainforest regions. Meanwhile, Napo Pharmaceuticals is dedicated to advancing treatments for marginalized gastrointestinal ailments within complex diseases affecting humans.
Jaguar Health focuses on producing advanced, sustainable plant-based medications from rainforest regions to treat various gastrointestinal conditions, while its subsidiary, Napo, is committed to addressing unattended gastrointestinal symptoms in medically complicated conditions.