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FDA Feedback Supports Extension Phase for Jaguar Health's Clinical Trial of Crofelemer for Treatment of Microvillus Inclusion Disease (MVID)
MVID has a lethal natural history requiring life-sustaining parenteral support (PS), which includes total parenteral nutrition (TPN), which is associated with
About this update from Jaguar Health, Inc.
[{"type":"text","content":"MVID has a lethal natural history requiring life-sustaining parenteral support (PS), which includes total parenteral nutrition (TPN), which is associated with significant toxicities; PS reduction could potentially reduce co-morbidities and improve clinical benefit, as no approved therapies exist for MVIDJaguar launches news alert text service for investors - click here to sign up for text alerts SAN FRANCISCO, CA / ACCESS Newswire / March 18, 2026 / Jaguar Health, Inc.(NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that, based on the U.S. Food and Drug Administration (FDA) support for Napo's protocol amendment for its clinical trial to evaluate the safety and efficacy of its novel crofelemer powder-for-oral-solution formulation in pediatric patients with intestinal failure due to MVID, an ultrarare pediatric disorder, Napo plans to initiate a single-blind extension phase for the trial. The extended treatment period has the potential to improve clinical benefit of crofelemer through reduction of parenteral support (PS) requirements, which may result in disease progression-modification of MVID.\"We are pleased to have the opportunity to continue treatment with crofelemer powder for oral solution in our ongoing clinical trial of crofelemer in pediatric MVID patients,\" said Pravin Chaturvedi, PhD, Jaguar's Chief Scientific Officer and Chair of the Jaguar and Napo Scientific Advisory Board. \"This would allow patients who have completed their double-blind treatment period to be eligible for the single-blind phase of continued treatment with crofelemer for further assessment of clinical benefit through reduction of PS for a longer period. PS reduction could potentially reduce co-morbidities associated with the disease and TPN; thus improving clinical benefit and modifying the disease progression to help address the lethal natural history of MVID.\"The dose selection for the single-blind extension phase will be determined by the study's independent Data Monitoring Committee (DMC), which will ensure that the study clinicians and Napo personnel will remain blinded. Currently, approximately 30% of the participating MVID patients have completed the study's double-blind treatment phase and the clinical investigators are supporting the patients' participation in the single-blind extended phase.This trial of...