Jaguar Health Advances Clinical Trials for Crofelemer in Rare Diseases in Europe

Jaguar Health, Inc., under its Napo Pharmaceuticals and Napo Therapeutics subsidiaries, has submitted Clinical Trial Applications (CTA) in Italy and Germany to begin phase 2 trials of crofelemer for the treatment of short bowel syndrome (SBS) with intestinal failure in adults. A separate CTA was submitted to AIFA, the Italian health authority, for a pediatric trial targeting microvillus inclusion disease (MVID), with additional approval processes underway in the United Arab Emirates.

These trials aim to address the unmet medical needs of MVID and SBS patients, who often rely heavily on parenteral nutrition. MVID, an ultra-rare congenital disorder, and SBS, a condition that can lead to severe complications including chronic diarrhea and malnutrition, currently lack approved drug treatments.

Lisa Conte, Jaguar’s President and CEO, highlighted the submission of these CTAs as critical regulatory milestones in the development of a novel powder formulation of crofelemer intended for these patient populations. The company anticipates that, subject to successful trial outcomes and regulatory approval, crofelemer could significantly alleviate the burden of these severe conditions.