Jaguar Health announces FDA activation of third-party IND for crofelemer

Jaguar Health announced the activation by the U.S. Food and Drug Administration of a physician-requested Investigational New Drug application to evaluate crofelemer for treatment of uncontrolled diarrhea in a patient with short bowel syndrome, a rare and complex condition characterized by diarrhea and/or severe malabsorption of fluids and nutrients. Napo Pharmaceuticals, a Jaguar company, is supporting this investigator-initiated trial of crofelemer, the Company’s oral anti-diarrheal prescription drug. Some SBS patients are subject to intestinal failure, often requiring PN from a few to up to 7 days a week. Intestinal failure is associated with significant morbidity and mortality; and high medical expenses associated with PN. SBS patients with intestinal failure also have severe chronic diarrhea, and the associated sequelae from diarrhea, including significant dehydration, metabolic acidosis or alkalosis and malnutrition, and other secondary symptoms, and these symptoms emerge either early or late, and many times become life-threatening. In June 2023, Napo Pharmaceuticals submitted an IND application to the FDA for a powder formulation of crofelemer for oral solution for the treatment of microvillus inclusion disease, an ultrarare congenital diarrheal disorder that affects newborns and children, leading to intestinal failure, significant morbidity and even death from severe secretory diarrhea. The Company is supporting investigator-initiated proof-of-concept studies of crofelemer for SBS with intestinal failure and MVID in the European Union and Middle East/North Africa regions. In accordance with the guidelines of specific EU countries, published data from such clinical investigations could support reimbursed early patient access to crofelemer for SBS or MVID, potentially in 2024, for these debilitating conditions.