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Jaguar Health Announces Active Treatment Only Continuation of Pivotal Multicenter Clinical Trial in Pediatric Patients with Microvillus Inclusion Disease (MVID) to Support a New Drug Application (NDA) for Liquid Oral Crofelemer
First MVID patient enters the active treatment only extension phase after completion of randomized double-blind crossover period to evaluate longer-term
About this update from Jaguar Health, Inc.
[{"type":"text","content":"First MVID patient enters the active treatment only extension phase after completion of randomized double-blind crossover period to evaluate longer-term safety and efficacy with liquid oral crofelemer as adjunctive treatment for MVID, an ultrarare pediatric disease with a lethal natural history and no approved therapies, requiring lifelong parenteral support (PS) SAN FRANCISCO, CA / ACCESS Newswire / May 19, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) announced that the first patient from the cohort of pediatric MVID patients in the pivotal MVID randomized double-blind crossover clinical trial has entered the active treatment only single-blind extension to evaluate the longer term safety and efficacy of crofelemer powder for oral solution as adjunctive treatment to parenteral support (PS) to support regulatory submissions for the drug to treat this serious unmet medical need. The trial is being conducted at multiple centers with appropriate regulatory approvals in the United States (US), European Union (EU), and United Arab Emirates (UAE).MVID is an ultrarare congenital enteropathy that causes intestinal failure (IF) from early childhood. Patients with MVID require lifelong and life-sustaining PS, consisting of total parenteral nutrition (TPN) with or without supplemental intravenous fluids, to provide the life-sustaining nutrients, electrolytes, and fluids for survival. Most MVID patients require daily PS, sometimes for 20 hours or more per day. While crucial for growth and survival for these patients, PS is associated with significant comorbidities, such as liver and kidney toxicities, metabolic complications, infections, and neurodevelopmental delays. There are currently no approved drug treatments for MVID. Incidence of MVID is extremely rare with a lethal natural history. The company estimates that oral liquid crofelemer treatment is being used as adjunctive therapy with PS in up to 4% of the prevalent global MVID patient population.\"In MVID, the therapeutic goal is to evaluate crofelemer's oral treatment to reduce the increased needs of PS to support growth, hydration, electrolytes, and nutritional requirements. This single-blind extension phase is an important clinical milestone for our pivotal randomized double-blind crossover clinical trial of crofelemer in the MVID tria...