Jaguar Health’s Napo to meet with FDA on pathways for croflemer in MVID

Jaguar Health’s (JAGX) Napo Pharmaceuticals plans to meet with the U.S. Food and Drug Administration to discuss the company’s ongoing clinical development program for crofelemerfor the treatment of microvillus inclusion disease, an ultrarare pediatric disorder. Members of Napo’s Scientific Advisory Board will join Napo and Jaguar representatives at the meeting. As announced, and as presented April 26, 2025 at the Annual ELITE PED-GI Congress, the initial proof-of-concept results of the ongoing investigator-initiated trial 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%. 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. Jaguar, through Napo, is supporting the independent proof-of-concept IIT in pediatric intestinal failure patients at Sheikh Khalifa Medical City in Abu Dhabi, and is conducting the placebo-controlled Phase 2 study of crofelemer in pediatric MVID patients with IF at sites in the U.S., European Union, and Middle East/North Africa regions under appropriate regulatory approvals in each of these geographies. Based on the initial findings from the IIT in Abu Dhabi, crofelemer’s paradigm-shifting mechanism of action has the potential to provide a novel therapeutic option to reduce parenteral support and associated complications in MVID patients.