STOCK TITAN

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

The pilot showed reduced ostomy volume in two participants, while three had increased ostomy output after treatment stopped.

Sentiment and the balance of points

Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.

Tags

Jaguar Health (JAGX) reported preliminary crofelemer results from an ongoing open-label pilot study in adults with short bowel syndrome and intestinal failure.

Presented October 13, 2026 at the American College of Gastroenterology meeting, results covered four protocol completers; planned enrollment is six. The primary endpoint is reduced ostomy volume, or intestinal output collected through a surgical opening. At 12 weeks, two subjects averaged a 5% reduction; one reduced parenteral support, intravenous nutrition and fluids, by 9%. Three averaged an 88% increase in urinary output, sustained four weeks after treatment stopped. Three averaged a 23% increase in ostomy output after stopping crofelemer. No significant adverse events were observed.

Napo expects adult Phase 2 results early in the second half of 2027. Jaguar plans a mid-2027 New Drug Application filing for microvillus inclusion disease.

Loading...
Loading translation...
8 points · 0 major

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

0 major · 2 points

Hollow bars mark forward-looking points. How the balance works

Positive

  • Moderate point. Forward-looking: it has not happened yet and may not happen.Jaguar plans a mid-2027 New Drug Application filing for microvillus inclusion disease.
  • Minor pointOstomy volume decreased by an average of 5% in two subjects at 12 weeks.
  • Minor pointParenteral support volume decreased by 9% in one subject at 12 weeks.
  • Minor pointUrinary output improved by an average of 88% in three subjects, sustained four weeks after treatment cessation.
  • Minor pointSafety observations showed no significant adverse events in any subjects; crofelemer was well tolerated.
3 minor points
  • Minor pointOngoing pediatric investigations showed reduced weekly and weight-normalized parenteral support needs with dosing exceeding one year.
  • Minor pointPediatric investigations reported no significant clinical or laboratory abnormalities.
  • Minor point. Forward-looking: it has not happened yet and may not happen.Napo is conducting a randomized, double-blind, placebo-controlled Phase 2 trial; results are expected early in second-half 2027.

Negative

  • Minor point. Forward-looking: it has not happened yet and may not happen.Pilot findings are preliminary and open-label, with four protocol completers against planned enrollment of six.
  • Minor pointOstomy output increased by an average of 23% in three subjects after crofelemer cessation.

Key Figures

Participants completing protocol: 4 participants Ostomy volume reduction: 5% average Ostomy output increase after cessation: 23% average +2 more
Participants completing protocol
4 participants
Ongoing open-label adult T1SBS study
Ostomy volume reduction
5% average
Two subjects at 12 weeks of treatment
Ostomy output increase after cessation
23% average
Three subjects after stopping crofelemer
Parenteral support volume reduction
9%
One subject at 12 weeks of treatment
Urinary output improvement
88% average
Three subjects at 12 weeks; sustained 4 weeks after cessation

Key Terms

open-label, total parenteral nutrition, double-blind placebo-controlled, phase 2 clinical trial, +1 more
5 terms
open-label technical
"ongoing open-label pilot study"
Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.
total parenteral nutrition medical
"require lifelong total parenteral nutrition (TPN)"
Total parenteral nutrition is a medical treatment that supplies all needed calories, fluids, vitamins and minerals directly into a patient’s bloodstream through an IV, bypassing the digestive tract — like a complete meal delivered by a drip. It matters to investors because TPN relies on specialized ingredients, preparation and delivery services with steady hospital and home-care demand, significant regulation and reimbursement exposure, and potential for durable revenue or risk from supply-chain or clinical issues.
double-blind placebo-controlled technical
"multicenter, randomized double-blind placebo-controlled Phase 2 clinical trial"
A double-blind placebo-controlled study is a medical test where participants are randomly given either the experimental treatment or an inactive look-alike (placebo), and neither the participants nor the researchers know who got which until the study ends. This setup reduces bias and makes the results more reliable for assessing whether a treatment truly works, which matters to investors because clearer evidence lowers uncertainty about future approvals, sales, and financial prospects.
phase 2 clinical trial technical
"a multicenter, randomized double-blind placebo-controlled Phase 2 clinical trial"
A phase 2 clinical trial is a research study that tests a new medical treatment or drug to see if it is effective and safe for a specific condition. It involves a larger group of people than earlier trials and helps determine whether the treatment should move forward to more extensive testing. For investors, successful phase 2 results can signal potential for future approval and commercial success, while setbacks may indicate challenges ahead.
new drug application regulatory
"planned New Drug Application (NDA) filing for MVID in mid-2027"
A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google

SAN FRANCISCO, CA / ACCESS Newswire / October 14, 2026 / Jaguar Health, Inc. (Nasdaq:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today provided a recap of the positive preliminary results presented on October 13, 2026 at the American College of Gastroenterology Annual Scientific Meeting (ACG 2026) for the ongoing open-label pilot study of the company's crofelemer powder for oral solution in adult patients with Type 1 short bowel syndrome (T1SBS) with intestinal failure (SBS-IF). The abstract presented at ACG 2026, titled The Use of Crofelemer in Reducing Ostomy Output in Patients With Type 1 Short Bowel Syndrome: An Open Label Pilot Study, can be viewed by clicking here.

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 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.

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:

hello@jaguar.health

Jaguar-JAGX

SOURCE: Jaguar Health, Inc.



View the original press release on ACCESS Newswire

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Jaguar Health's crofelemer pilot show on its primary endpoint?

Two subjects had decreased ostomy volume by an average of 5% at 12 weeks, the study's primary endpoint. Four participants completed the protocol in the ongoing open-label pilot, which plans to enroll six subjects.

When does Jaguar Health expect its next crofelemer clinical and regulatory milestones?

Napo expects adult Type 1 short bowel syndrome Phase 2 results early in the second half of 2027, and Jaguar plans a New Drug Application filing for microvillus inclusion disease in mid-2027.

How was crofelemer administered in Jaguar Health's adult short bowel syndrome pilot?

Patients received liquid crofelemer orally at 3 mg/kg/dose three times daily for 12 weeks. Participants had Type 1 short bowel syndrome with intestinal failure and were receiving stable parenteral support, comprising intravenous nutrition with or without supplemental intravenous fluids.

Keep reading