Jaguar Health’s Napo providing crofelemer powder for use in two EAPs

Jaguar Health’s (JAGX) Napo Pharmaceuticals is providing the company’s novel crofelemer powder for oral solution for use in two expanded access programs, authorized by the U.S. Food and Drug Administration , to treat pediatric intestinal failure patients with microvillus inclusion disease. Jaguar, through Jaguar family companies Napo and Napo Therapeutics, is currently supporting two independent proof-of-concept investigator-initiated trials, and conducting two placebo-controlled clinical studies, of crofelemer in patients with intestinal failure due to the ultrarare disease MVID and the rare disease indication short bowel syndrome with intestinal failure in the United States, European Union, and/or Middle East/North Africa regions under appropriate regulatory approvals in each of these geographies. As announced, and as presented April 26, 2025 at the Annual ELITE PED-GI Congress, the initial proof-of-concept results of the ongoing IIT of a novel crofelemer powder formulation for oral solution in Abu Dhabi in the United Arab Emirates show that crofelemer reduced the required total parenteral nutrition 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%. An abstract describing the initial results of this trial has been accepted for presentation at the upcoming North American Society for Pediatric Gastroenterology, Hepatology and Nutrition Annual Meeting taking place November 5-8, 2025 in Chicago. Additional proof-of-concept results from IITs of crofelemer for MVID and SBS-IF are expected later in 2025 and will provide additional preliminary data on the safety and potential effectiveness of crofelemer for these highly unmet clinical needs. Data from both above-referenced placebo-controlled clinical studies is expected in 2026.