Jaguar Health’s Napo reports preliminary results from IIT trial of crofelemer

Jaguar Health’s (JAGX) Napo Pharmaceuticals and Napo Therapeutics announced that preliminary results from the ongoing pediatric investigator-initiated trial of a novel liquid formulation of crofelemer, Jaguar’s novel plant-based anti-secretory prescription drug, for various congenital diarrheal disorders, including MVID and SBS with intestinal failure, will be presented by Dr. Mohamad Miqdady at the April 24-26, 2025 Annual ELITE PED-GI Congress in Abu Dhabi in the United Arab Emirates. MVID and SBS-IF, rare orphan diseases requiring intensive parenteral nutrition and support, have severe morbidity and mortality implications and impact the quality of life of both patients and their caregivers. There are currently no approved drug treatments for MVID. A key value driver would be a reduction in total parenteral nutrition. This ongoing proof-of-concept study is evaluating crofelemer’s potential to be safely administered to patients with MVID, SBS-IF, and other CDDs in escalating doses, improve stool formation, improve the absorption of nutrients, and lower TPN needs – which have never been achieved in an MVID patient. The study also provides the opportunity to evaluate whether any potential benefit provided by crofelemer in participating patients ceases after treatment with crofelemer is discontinued. Napo expects that if even just a very small number of MVID patients show benefit with crofelemer, this may potentially allow pathways for regulatory approval in the US and other regions and qualify crofelemer for participation in PRIME, a European Medicines Agency program providing enhanced interaction and early dialogue with drug developers of novel medicines targeting unmet medical needs; early patient access in certain EU countries; and in the U.S. Food and Drug Administration’s Breakthrough Therapies program. If a drug is designated as breakthrough therapy, the FDA will expedite the development and review of the drug. This study is being conducted at Sheikh Khalifa Medical City, a flagship tertiary hospital in the United Arab Emirates and the largest teaching medical center in Abu Dhabi, by Dr. Mohamad Miqdady, a recognized leader in pediatric gastroenterology who is SKMC’s Division Chief of the Pediatric Gastroenterology, Hepatology & Nutrition Division.