Jaguar Health's Crofelemer Shows Benefit for Intestinal Failure (IF) in Third Rare Congenital Enteropathy Disorder

Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) today announced that Jaguar family company Napo Pharmaceuticals (Napo) has been continuing to provide the company's novel crofelemer powder for oral solution for several weeks for the treatment of intestinal failure (IF) in an infant patient with GUCY2C mutation resulting in congenital sodium diarrhea (CSD). Liquid oral crofelemer therapy is well tolerated by this patient and has demonstrated reduced needs for daily and weekly parenteral support (PS) with no significant clinical or laboratory abnormalities. CSD due to mutation of the GUCY2C gene is the third IF-related congenital enteropathy being evaluated under expanded access, in addition to pediatric microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF), for which crofelemer has demonstrated benefit in reducing weekly parenteral support needs normalized to body weight. The company plans to file a New Drug Application (NDA) for crofelemer for MVID in mid-2027 to obtain FDA approval based on data that will include results from an ongoing pivotal trial which has completed enrollment.

Patients with IF, including those with short bowel syndrome (SBS) or MVID, cannot orally absorb adequate nutrients, electrolytes and fluids, and require lifelong total parenteral nutrition (TPN) with or without supplemental intravenous fluids, which together comprise parenteral support (PS), for up to seven days per week and up to 20+ hours per day. While PS is supportive and lifesaving, it is associated with serious, sometimes fatal complications.

Pediatric CSD patients with GUCY2C mutation have a significant challenge for managing nutritional and electrolyte deficiencies, given the higher impact on growth and developmental needs. This pediatric patient with IF due to CSD requires significant daily PS, and liquid oral crofelemer therapy has reduced their daily PS needs by approximately 15% within the first several weeks, consistent with what was observed in pediatric IF patients with MVID and SBS.

Napo remains sharply focused on its ongoing global development program for oral crofelemer as adjunctive therapy to PS for pediatric rare IF diseases. In June 2026, as announced, data was presented at the 58th Annual European Society for Pediatric Gastroenterology, Hepatology & Nutrition (ESPGHAN) Meeting in Lille, France from ongoing investigational studies with oral liquid crofelemer in pediatric patients with IF due to MVID and SBS-IF. The results of ongoing investigations of liquid oral crofelemer formulations demonstrate substantial reductions in weekly PS needs as well as in PS normalized to body weight in pediatric IF patients dosed orally for more than one year, with no significant clinical or laboratory abnormalities. In one MVID patient, the weekly PS requirements normalized to body weight have been reduced by up to 48% following >12 months of liquid oral high-dose crofelemer therapy. In two pediatric SBS-IF patients, weekly PS requirements normalized to body weight were reduced up to 40% following >12 months of liquid oral high dose crofelemer therapy.

About Crofelemer

Crofelemer is a novel, oral plant-based prescription medicine purified from the red bark sap, also referred to as "dragon's blood," of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for indigenous communities.

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, Inc. (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 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 the company may file an NDA (New Drug Application) with the U.S. Food and Drug Administration (FDA) for the MVID indication in mid-2027 based on data that will include results from an ongoing pivotal trial which has completed enrollment. 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:

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SOURCE: Jaguar Health, Inc.