REMINDER: Initial Groundbreaking Results of Proof-of-Concept Study of Jaguar Health's Crofelemer for Treatment of Pediatric Intestinal Failure to be Presented November 8, 2025 at North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting

Rhea-AI Summary

Jaguar Health (NASDAQ:JAGX) reminded investors that partial results from an investigator-initiated proof-of-concept trial of crofelemer in pediatric intestinal failure will be presented on November 8, 2025 at NASPGHAN.

Initial open-label UAE data show reductions in total parenteral support (PS) of 12%–37% in pediatric patients including microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF). The company is supporting a placebo-controlled pediatric MVID trial across the U.S., EU and Middle East, supplying crofelemer for two FDA-authorized expanded access programs in the U.S., and supporting an IIT in U.S. adult SBS-IF patients.

Positive

• PS reduction of 12%–37% reported in UAE pediatric trial
• Company supporting placebo-controlled pediatric MVID trial in U.S., EU, Middle East
• Crofelemer supplied for two FDA-authorized expanded access programs in the U.S.

Negative

• Results are from a pilot open-label investigator-initiated trial
• Durability and longer-term safety remain under evaluation
• MVID prevalence estimated at 100–200 worldwide, indicating an ultra-rare patient pool

Results of ongoing investigator-initiated proof-of-concept trial of crofelemer in United Arab Emirates (UAE) demonstrate disease progression modification and reduction of total parenteral support (PS) in pediatric intestinal failure patients ranging between 12% to 37%

SAN FRANCISCO, CA / ACCESS Newswire / November 6, 2025 / Jaguar Health, Inc.(NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today issued a reminder that an abstract describing partial results of the independent and ongoing investigator-initiated trial (IIT) of crofelemer in the UAE for treatment of pediatric intestinal failure, which includes patients with intestinal failure due to microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF), will be presented this coming Saturday, November 8, 2025, at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting taking place November 5-8, 2025 in Chicago.

The results of the ongoing investigator-initiated proof-of-concept trial in the UAE demonstrate reduction of total parenteral support (PS) (comprised of total parenteral nutrition and supplementary IV fluids) in pediatric intestinal failure patients ranging between 12% to 37%.

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 to meet the nutritional, fluid and electrolyte requirements of the child, and for which there are currently no approved treatments. MVID has a lethal natural history along with significant co-morbidities. SBS affects approximately 10,000 to 20,000 people in the U.S., according to the Crohn's & Colitis Foundation, and it is estimated that the population of SBS patients in Europe is approximately the same size.

"We are very pleased with the initial findings from this pilot open-label study in pediatric intestinal failure patients with MVID and SBS. The unique mechanism of action of crofelemer and the reductions achieved in the average weekly parenteral support volumes buttress the ongoing investigation of crofelemer in pediatric intestinal failure patients. The ability to reduce PS needs is disease progression modification that has a groundbreaking impact on patient well-being as well as quality of life. We will continue to evaluate the longer-term safety and durability of these reductions in intestinal failure patients over the coming weeks," said Pravin Chaturvedi, PhD, Napo's and Jaguar's Chief Scientific Officer and Chair of the Scientific Advisory Board.

In addition to supporting the IIT in the UAE and conducting the placebo-controlled clinical trial of crofelemer in pediatric MVID patients at sites in the U.S., E.U., and Middle East under appropriate regulatory approvals in each of these geographies, the company is providing crofelemer powder for oral solution for use in two expanded access programs in the U.S., authorized by the FDA, to treat pediatric intestinal failure patients with MVID. The company is also supporting an IIT in the U.S. of crofelemer in adult SBS-IF patients.

About the Jaguar Health Family of Companies

Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress. Jaguar family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome.

For more information about:

Jaguar Health, visit https://jaguar.health
Napo Pharmaceuticals, visit www.napopharma.com
Napo Therapeutics, visit napotherapeutics.com

Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that an abstract describing partial results of the ongoing IIT in the UAE will be presented at the 2025 NASPGHAN Annual Meeting. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Contact:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire

FAQ

When will Jaguar Health present crofelemer pediatric intestinal failure results at NASPGHAN 2025?

Partial results will be presented on November 8, 2025 at the NASPGHAN annual meeting.

What reduction in parenteral support did the JAGX-supported UAE pilot study report?

The ongoing pilot study reported reductions in total parenteral support between 12% and 37%.

Does Jaguar have a controlled trial for crofelemer in pediatric MVID and where?

Yes, Jaguar is supporting a placebo-controlled pediatric MVID trial at sites in the U.S., EU and Middle East.

Is crofelemer available to U.S. pediatric intestinal failure patients now under JAGX programs?

The company is providing crofelemer powder for oral solution for use in two FDA-authorized expanded access programs in the U.S.

What patient groups were included in the UAE crofelemer investigator-initiated trial?

The trial included pediatric patients with MVID and SBS-IF (short bowel syndrome with intestinal failure).