Jaguar Health Begins Pediatric Trial for Crofelemer in Short Bowel Syndrome

Jaguar Health, Inc, and Napo Therapeutics revealed that the initial patient suffering from short bowel syndrome with intestinal failure (SBS-IF) has been treated in the independently initiated pediatric proof-of-concept trial (IIT) for crofelemer, Jaguar's innovative plant-derived antidiarrheal prescription medication. The initial infant affected by microvillus inclusion disease (MVID) received treatment as part of the same IIT two weeks prior.

The study is led by Dr. Mohamad Miqdady, a prominent expert in pediatric gastroenterology who serves as the Division Chief of the Pediatric Gastroenterology, Hepatology & Nutrition Division at Sheikh Khalifa Medical City (SKMC), a leading tertiary hospital in the UAE and the largest educational medical center in Abu Dhabi.

"This study is one of five clinical efforts in rare diseases - three POC IIT studies and two phase 2 studies - for crofelemer for the orphan disease indications of MVID and/or SBS-IF in the United States, European Union, and/or Middle East and North Africa (MENA) regions," Conte said. "The company's phase 2 study to evaluate the efficacy of crofelemer for MVID in paediatric patients has been initiated, as has the independent IIT in the US to evaluate crofelemer for SBS-IF in adults. The two additional studies are expected to initiate in early Q1 2025, with the availability of the first POC IIT result potentially in H1 2025, and with additional POC IIT results expected throughout 2025. In accordance with the guidelines of specific EU countries, published data from clinical investigations in MVID and SBS-IF could support reimbursed early patient access to crofelemer for these debilitating conditions."