News Release Details
News Release Details
Positive Preliminary Results Presented at Annual American College of Gastroenterology Meeting for Open-Label Study in Adult Short Bowel Syndrome Patients with Intestinal Failure (SBS-IF) with Jaguar Health's Crofelemer
Patients with intestinal failure (IF), including those with short bowel syndrome or pediatric patients with 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.
Patients with Type 1 SBS, defined as having less than 200 cm of small bowel length to ostomy, frequently struggle with high volume ostomy output leading to electrolyte disturbances and decreased quality of life. In this open-label study, IF patients with T1SBS on stable PS were given liquid crofelemer (3 mg/kg/dose) orally three times daily for 12 weeks. This study is ongoing and plans to enroll 6 subjects. The primary endpoint is reduction of ostomy volume (OV). Four participants have completed the protocol. Two subjects had decreased OV at 12 weeks of treatment by an average of 5%, and three subjects had increased ostomy output following the cessation of crofelemer by an average of 23%. One subject had decreased PS volume by 9% at 12 weeks of treatment. Three subjects had improved urinary output at 12 weeks by an average of 88% which was sustained at 4-weeks post cessation of oral crofelemer therapy. No significant adverse events were observed in any subjects, and crofelemer is well tolerated.
Napo remains sharply focused on its ongoing global development programs for oral crofelemer therapy in IF patients receiving PS for rare diseases, including SBS-IF and pediatric MVID. In
Napo is conducting a multicenter, randomized double-blind placebo-controlled Phase 2 clinical trial in adult T1SBS patients without colin-in-continuity. Results from this trial are expected to be available early in the second half of 2027.
Jaguar's IF program is expected to continue to provide clinical milestones, including a planned New Drug Application (NDA) filing for MVID in mid-2027.
About the Jaguar Health Family of Companies
Jaguar Health, Inc. ("Jaguar") develops novel proprietary prescription drugs sustainably derived from plants for people with complicated gastrointestinal ("GI") disease states. Jaguar family companies Napo Pharmaceuticals, Inc. 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. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.
For more information about:
Jaguar Health, visit https://jaguar.health
Napo Pharmaceuticals, visit napopharma.com
Napo Therapeutics, visit napotherapeutics.com
Magdalena Biosciences, visit magdalenabiosciences.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 for crofelemer for MVID in mid-2027, and Jaguar's expectation that results from Napo's Phase 2 study of crofelemer in adult T1SBS patients without colin-in-continuity may be available early in the second half of 2027. 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 a number of 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:
Jaguar-JAGX
SOURCE: Jaguar Health, Inc.
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