Business
Jaguar Health Announces First Patient Dosed in Short Bowel Syndrome with Intestinal Failure in Investigator-Initiated Trial of Crofelemer; Proof-of-Concept Data Potentially Available H1 2025
Trial taking place at Sheikh Khalifa Medical City, a flagship United Arab Emirates hospital and largest teaching medical center in Abu DhabiCrofelemer,
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Trial taking place at Sheikh Khalifa Medical City, a flagship United Arab Emirates hospital and largest teaching medical center in Abu DhabiCrofelemer, Jaguar's novel plant-based prescription drug, has been granted Orphan Drug Designation by the FDA and the European Medicines Agency for both SBS-IF and MVIDProof-of-concept (POC) data generated from this study could potentially lead to reimbursed early patient access in certain European countries for crofelemer for these rare/orphan diseases SAN FRANCISCO, CA / ACCESS Newswire / February 3, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics today announced that the first short bowel syndrome with intestinal failure (SBS-IF) patient has been dosed in the independent investigator-initiated pediatric POC trial (IIT) of crofelemer, Jaguar's novel plant-based antidiarrheal prescription drug. The first infant with microvillus inclusion disease (MVID) was dosed as part of the same IIT two weeks ago. POC data generated from this study potentially in the first half of 2025 could lead to reimbursed early patient access to crofelemer for these indications in certain European countries.The trial is being conducted by Dr. Mohamad Miqdady, a recognized leader in pediatric gastroenterology who is the Division Chief of the Pediatric Gastroenterology, Hepatology & Nutrition Division at Sheikh Khalifa Medical City (SKMC), a flagship tertiary hospital in the UAE and the largest teaching medical center in Abu Dhabi.\"Dosing of the SBS-IF first patient in this unblinded study is another important milestone in clinical development efforts for crofelemer for SBS-IF and MVID - both of which are rare and severe diseases requiring intensive parenteral nutrition and support,\" said Lisa Conte, Jaguar's founder, president, and CEO.\"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 pediatric patients has been initiated, as has the independent IIT in the U.S. to evaluate crofelemer for SBS-IF in adults. The two additional studies ar...