Jaguar Health MVID trial moves to extension phase ahead of 2027 NDA

Jaguar Health, Inc. (NASDAQ: JAGX) subsidiary Napo Pharmaceuticals announced that all randomized pediatric patients in its pivotal crossover clinical trial of crofelemer for microvillus inclusion disease (MVID) with intestinal failure have entered a single-blind extension phase, according to a press release dated September 10, 2026.

The extension phase will have patients receive blinded doses of crofelemer powder for oral solution as adjunctive therapy to parenteral support. The trial is running at multiple centers in the United States, the European Union, and the United Arab Emirates. Napo expects the data to support a New Drug Application filing for the MVID indication in mid-2027.

An independent Data Monitoring Committee evaluated safety and tolerability of crofelemer during the randomized double-blind crossover period and authorized continuation of active treatment in the extension phase.

MVID is described as an ultrarare pediatric disorder with an estimated worldwide prevalence of approximately 200 patients. Patients with intestinal failure cannot orally absorb adequate nutrients, electrolytes, and fluids, requiring lifelong total parenteral nutrition for up to seven days per week and up to 20 or more hours per day.

Data presented at the 58th Annual European Society for Pediatric Gastroenterology, Hepatology and Nutrition meeting in June 2026 showed reductions in weekly parenteral support needs in pediatric intestinal failure patients. In one MVID patient, weekly parenteral support requirements normalized to body weight were reduced by up to 48% following more than 12 months of liquid oral high-dose crofelemer therapy. In two pediatric short bowel syndrome patients, reductions of up to 40% were reported under similar conditions.

Napo also stated it plans to complete a Phase 2 study in short bowel syndrome with intestinal failure by mid-2027. The company said its intestinal failure program is the subject of business development discussions that could bring in non-dilutive funds from potential licensee partners. Upon trial completion, data may be used to pursue a Breakthrough Therapy Designation application.

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