Jaguar Health Announces Preliminary Results From Ongoing Pediatric Investigator-Initiated Trial Of A Novel Liquid Formulation Of Crofelemer Will Be Presented By Dr. Mohamad Miqdady At April 24-26, 2025 Annual ELITE PED-GI Congress in Abu Dhabi in the United Arab Emirates

Crofelemer, a novel plant-based anti-secretory prescription drug, has been granted Orphan Drug Designation by the FDA and the European Medicines Agency (EMA) for both short bowel syndrome (SBS) and microvillus inclusion disease (MVID) and is being evaluated to serve as a potential therapeutic option to manage intestinal failure in these patients

There are currently no approved drug treatments for MVID, an ultrarare pediatric disease characterized by severe diarrhea and malabsorption that requires intensive parenteral support for nutritional and fluid management

Proof-of-concept data in MVID from this study would provide support for crofelemer's potential inclusion in the EMA's PRIME program for novel medicines targeting unmet medical needs and the FDA's Breakthrough Therapies program

SAN FRANCISCO, CA / ACCESS Newswire / April 17, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics today announced that preliminary results from the ongoing pediatric investigator-initiated trial (IIT) of a novel liquid formulation of crofelemer, Jaguar's novel plant-based anti-secretory prescription drug, for various congenital diarrheal disorders (CDD), including MVID and SBS with intestinal failure (SBS-IF), 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 (TPN).

"Patients with MVID and SBS-IF suffer from devastating diarrhea and dehydration caused by these debilitating, lifelong conditions. These patients are frequently on TPN for as long as 20 hours a day, seven days a week - and TPN carries a significant risk of morbidity, including infections, metabolic complications, and liver problems," said Dr. Miqdady, the principal investigator for this study. "I look forward to presenting preliminary, proof-of-concept results from this study at the ELITE PED-GI Congress."

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.