Jaguar Health announces publication of independent study on crofelemer

Jaguar Health announced that an independent, investigator-initiated study evaluating the efficacy of crofelemer, the Company’s plant-based prescription drug, for the treatment of microvillus inclusion disease has been published in The Journal of Clinical Investigation, a peer-reviewed medical journal covering biomedical research. The results of this in vitro study demonstrate that crofelemer has the clinical potential for symptomatic therapy and electrolyte and fluid management in MVID patients. MVID is a severe infantile disease characterized by diarrhea, malabsorption, and acid/base instability, requiring intensive parenteral support for nutritional and fluid management, and there are currently no approved drug treatments. This study, titled “Patient-derived enteroids provide a platform for the development of therapeutic approaches in microvillus inclusion disease,” was conducted by Jay Thiagarajah, MD, PhD, who is Co-Director of the Congenital Enteropathy Program, and an Attending Physician in the Division of Gastroenterology, Hepatology and Nutrition, at Boston Children’s Hospital, Harvard Medical School, where Dr. Thiagarajah also serves as Assistant Professor of Pediatrics. MVID patients commonly face intestinal failure – a catastrophic health situation that also often afflicts patients with short bowel syndrome. Crofelemer has been granted Orphan Drug Designation by the U.S. Food and Drug Administration and the European Medicines Agency for both MVID and SBS. Jaguar is supporting investigator-initiated and investigator IND proof-of-concept studies of crofelemer for MVID and SBS with intestinal failure in the US, EU, and Middle East/North Africa regions, with results expected before the end of 2023 and in 2024. In accordance with the guidelines of specific European Union 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. The Company’s Investigational New Drug application for crofelemer for the treatment of MVID was activated by the FDA August 7, 2023.