Jaguar Health Submits Abstract for Crofelemer Trial in Adult Short Bowel Syndrome Patients
核心洞察
Jaguar Health announced abstract submission for preliminary data from a US investigator-initiated trial evaluating crofelemer in adult patients with short bowel syndrome with intestinal failure (SBS-IF).
The study focuses on reducing dependence on parenteral support, a critical unmet need for SBS-IF patients who require life-sustaining intravenous nutrition up to 20 hours daily.
Previous trial results in pediatric patients showed crofelemer reduced parenteral support needs by 12-37%, supporting continued evaluation of the drug for intestinal failure conditions.
Jaguar Health, Inc. (NASDAQ:JAGX) announced that an independent investigator at a leading SBS-IF treatment institution has submitted an abstract describing preliminary findings from a clinical trial evaluating a novel oral liquid formulation of crofelemer in adult patients with short bowel syndrome with intestinal failure (SBS-IF). The abstract has been submitted for consideration for presentation at the May 2-5, 2026 Digestive Disease Week® conference.
The submission supports Jaguar's strategic focus on intestinal failure in adult short bowel syndrome patients, where reducing dependence on parenteral support remains a critical unmet medical need. SBS-IF represents the second orphan disease target indication for Jaguar's intestinal failure program, which includes the ultrarare genetic disorder microvillus inclusion disease (MVID). In October 2025, the company completed a meeting with the FDA in support of a possible expedited approval pathway for crofelemer for MVID.
Clinical Significance and Unmet Need
The intestines of patients with intestinal failure due to short bowel syndrome are unable to function like an intact gut, similar to patients with intestinal failure due to MVID. Intestinal failure is a debilitating condition that often requires patients to receive life-sustaining fluids, electrolytes and nutrients through intravenous administration, consisting of total parenteral nutrition (TPN) with supplemental intravenous fluids, which together constitute parenteral support (PS).
Many intestinal failure patients require PS up to 7 days a week, and sometimes for 20 hours or more per day. While crucial for intestinal failure patients, PS is associated with significant toxicities similar to some toxicities associated with chemotherapy, often causing serious health problems including infections, metabolic complications, and liver and kidney function problems. These symptoms may emerge at any time in intestinal failure patients and often become life-threatening.
Supporting Evidence from Ongoing Trials
Initial results from an ongoing independent proof-of-concept trial of crofelemer in the United Arab Emirates, presented November 8, 2025 at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting, demonstrate disease progression modification through reduction of PS in pediatric intestinal failure patients that ranged from 12 to 37%.
Specifically, in two pediatric SBS-IF patients who completed treatment, results showed crofelemer reduced PS between 12.5 to 15.6% at the highest dose over the 12-week treatment period, together with reduced loose watery stools frequency. For the initial MVID patient who completed treatment, PS needs were reduced by up to 27% at the highest dose over the initial 12-week treatment period and up to 37% during the extension period upon reinitiation of crofelemer treatment, with reduced frequency of loose watery stools.
"Findings from independent investigator-initiated studies provide proof-of-concept data and continue to build the evidence supporting crofelemer's ability to reduce stool and stomal output and the drug's potential to reduce parenteral support needs in patients with intestinal failure - a core focus of the company for treating rare and orphan GI disorders," said Lisa Conte, Jaguar's founder, president, and CEO.
Disease Prevalence and Market Context
Short bowel syndrome affects approximately 10,000 to 20,000 people in the US, according to the Crohn's & Colitis Foundation, with an estimated similar population size in Europe. MVID is a devastating ultrarare pediatric disorder with an estimated worldwide prevalence of 100-200 patients, characterized by severe malabsorption that requires life-sustaining parenteral support and has a lethal natural history with significant co-morbidities. Currently, no approved treatments exist for MVID.
Ongoing Clinical Development Program
In addition to supporting the ongoing investigator-initiated trial at the US institution, Napo Pharmaceuticals (搜索) is conducting a placebo-controlled clinical trial of crofelemer in adult SBS-IF patients at sites in the EU, and a placebo-controlled clinical trial of crofelemer in pediatric MVID patients at sites in the US, EU, and Middle East. The company is also supporting evaluation of crofelemer powder for oral solution in expanded access programs to treat intestinal failure in pediatric patients with MVID in the US.
Crofelemer has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for both SBS and MVID. The drug is a novel, oral plant-based highly purified prescription medicine derived from the crude plant latex of the Croton lechleri tree in the Amazon Rainforest, with Napo Pharmaceuticals (搜索) establishing a sustainable harvesting program under fair trade practices.