Jaguar Health submits amended protocol to FDA for placebo-controlled trial

Jaguar Health (JAGX) announced that, in support of a possible expedited approval pathway for crofelemer for treatment of intestinal failure in patients with the ultrarare genetic disorder microvillus inclusion disease, the company has submitted an amended protocol to the U.S. Food and Drug Administration for the company’s ongoing placebo-controlled clinical trial of crofelemer in pediatric MVID patients. MVID patients are born without the ability to absorb the basic nutrients of life, and are therefore subject to a lethal natural history and a lifetime of parenteral support which is associated with toxicities and comorbidities. The ability of crofelemer to decrease the volume of parenteral support is potentially life extending for these patients and is thus disease progression modifying. Crofelemer provides an opportunity for improved quality of life, potentially reducing the time MVID patients spend on parenteral nutrition and/or supplemental intravenous fluids by up to 37% a day from what is often up to 20 hours a day, 7 days a week to support the daily electrolyte and nutrient needs of the patient. “In light of the initial groundbreaking results of the investigator-initiated trial of crofelemer in the United Arab Emirates for treatment of MVID and in support of our efforts to make crofelemer available to children with MVID as quickly and efficiently as possible, as announced, the company met with the FDA on October 2, 2025 to seek their advice regarding our ongoing clinical trial of crofelemer for MVID treatment. Based on the feedback from the FDA during this meeting, we have proposed an amendment to our protocol for this study and submitted the amended protocol to the FDA for their review. Our expectation is that the amended protocol, along with the results of this study, if positive, will support a faster FDA review and approval of crofelemer for MVID,” said Pravin Chaturvedi, CSO.