All Randomized Pediatric Patients to Continue in the Single-Blind Extension Phase of Jaguar Health's Pivotal Clinical Trial of Crofelemer for Microvillus Inclusion Disease (MVID) with Intestinal Failure (IF)

Continuation of treatment with blinded doses of crofelemer in the extension phase of the trial will support company's plans to file an NDA in mid-2027 for MVID, an ultrarare pediatric disease

SAN FRANCISCO, CA / ACCESS Newswire / September 10, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that all randomized pediatric MVID patients in Napo's pivotal crossover clinical trial have entered the single-blind extension phase to receive blinded doses of crofelemer to support longer-term safety and efficacy for crofelemer powder for oral solution as adjunctive therapy to parenteral support (PS). The trial is ongoing at multiple centers in the United States, the European Union, and the United Arab Emirates. This trial is expected to support a New Drug Application (NDA) filing for the treatment of the MVID indication in mid-2027.

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

Napo remains sharply focused on its ongoing global development program for oral crofelemer as adjunctive therapy to PS for pediatric rare IF diseases, including MVID and short bowel syndrome with IF (SBS-IF). In June 2026, as announced, data was presented at the 58^th 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.

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