CSO of Napo Pharmaceuticals, a Jaguar Health Family Company, and Clinical Investigators Evaluating Crofelemer Conduct Panel Discussion at Pediatric Gastroenterology Conference in Dubai (UAE)

Napo plans a mid-2027 MVID drug application, with an ongoing placebo-controlled study needed to support regulatory requirements.

Rhea-AI Summary

Jaguar Health (JAGX) family company Napo Pharmaceuticals reviewed pediatric crofelemer findings at a panel discussion in Dubai on October 30, 2026. The discussion covered pediatric intestinal failure caused by microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF). Patients receiving liquid oral crofelemer for more than one year showed reduced parenteral support—intravenous nutrition and fluids—relative to body weight, alongside improved weight and stature.

Ongoing investigations also showed reduced weekly support needs, with no significant clinical or laboratory abnormalities. Panelists highlighted disease heterogeneity and the ongoing randomized, double-blind, placebo-controlled crossover study in MVID needed to support regulatory requirements. Napo expects pediatric MVID clinical milestones to support its planned New Drug Application filing in mid-2027.

4 points · 0 major

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0 major · 2 points

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

Positive

• Minor pointPediatric crofelemer investigations showed reduced weekly parenteral support and support normalized to body weight after more than one year.
• Minor pointPediatric patients receiving liquid oral crofelemer for more than one year showed improved weight and stature.
• Minor pointOngoing pediatric investigations reported no significant clinical or laboratory abnormalities.
• Minor point. Forward-looking: it has not happened yet and may not happen.Napo expects pediatric MVID milestones to support a planned New Drug Application filing in mid-2027.

Negative

• Moderate point. Forward-looking: it has not happened yet and may not happen.MVID regulatory requirements need support from the ongoing randomized, double-blind, placebo-controlled crossover study.
• Minor pointPediatric intestinal failure has disease heterogeneity, highlighted by panelists during the clinical discussion.

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Key Figures

Oral crofelemer treatment duration: >1 year Planned NDA filing: Mid-2027

Oral crofelemer treatment duration

>1 year

Pediatric MVID and SBS-IF patients discussed

Planned NDA filing

Mid-2027

For microvillus inclusion disease

Historical Context

1 past event · Latest: Oct 21

1 event

1. Oct 21

   Crofelemer findings

   24h Move

   -13.3%

   Reported pediatric MVID/SBS support reductions alongside additional infant intestinal-failure findings.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

total parenteral nutrition (tpn), microvillus inclusion disease (mvid), short bowel syndrome (sbs-if), randomized double-blind placebo-controlled crossover study, +1 more

5 terms

total parenteral nutrition (tpn) medical

"Intestinal Barrier: Beyond Total Parenteral Nutrition (TPN)"

Total parenteral nutrition (TPN) is a medical treatment that delivers all essential nutrients—calories, protein, electrolytes, vitamins and fluids—directly into a patient’s bloodstream through a vein when they cannot eat or digest food. Investors care because TPN drives revenue and costs across hospitals, specialty pharmacies, device makers and drug suppliers; changes in patient demand, safety issues, regulatory rules or reimbursement can materially affect sales, margins and supply chains, similar to how fuel shipments matter to transportation companies.

microvillus inclusion disease (mvid) medical

"including microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF)"

A rare, inherited disorder that appears in infants when cells lining the small intestine lack tiny hair‑like structures (microvilli), so the gut cannot absorb fluids and nutrients; this causes severe, life‑threatening diarrhea and often requires long‑term intravenous nutrition or other intensive care. For investors, MVID signals a clear unmet medical need that can make treatments, diagnostics or medical devices attractive targets for drug developers, diagnostic labs and specialty biotech firms because of potential regulatory incentives and high per‑patient value despite a small patient population.

short bowel syndrome (sbs-if) medical

"including microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF)"

Short bowel syndrome with intestinal failure (SBS-IF) is a chronic medical condition in which much of the small intestine is missing or not working, so the body cannot absorb enough water, calories, and nutrients and patients often require long-term intravenous or tube feeding. Investors care because SBS-IF drives demand for specialized drugs, medical devices, long-term care services and hospital resources, so advances, approvals, or cost changes can materially affect healthcare revenue and reimbursement dynamics — like a factory losing a conveyor belt and needing new systems to keep production running.

randomized double-blind placebo-controlled crossover study technical

"the ongoing randomized double-blind placebo-controlled crossover study in MVID patients"

A randomized double-blind placebo-controlled crossover study is a clinical trial design in which participants are randomly assigned to different treatment sequences, each person receives both the active treatment and a matching inactive placebo in separate time periods, and neither the participants nor the investigators know which treatment is given in any period. The crossover element means each participant serves as their own control, which reduces variability and increases statistical power, but it requires appropriate washout periods and analysis for period and carryover effects because lasting treatment effects or changes in the underlying condition can bias results. Randomization, blinding, and use of a placebo together aim to prevent selection bias, expectation effects, and measurement bias during each treatment period.

new drug application (nda) regulatory

"planned New Drug Application (NDA) filing for MVID in mid-2027"

A new drug application (NDA) is a formal request submitted to regulatory authorities to gain approval for a new medication to be sold and used by the public. It is a comprehensive review process that examines the drug’s safety, effectiveness, and manufacturing quality. For investors, an NDA approval can signal a potential breakthrough product and influence a company's stock value.

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SAN FRANCISCO, CA / ACCESS Newswire / November 2, 2026 / Jaguar Health, Inc. (Nasdaq:JAGX) family company Napo Pharmaceuticals (Napo) today provided a recap of the panel discussion titled Intestinal Barrier: Beyond Total Parenteral Nutrition (TPN) that took place on October 30, 2026 at the 2nd Best of Elite Ped-GI meeting in Dubai in the United Arab Emirates. Napo was one of the sponsors of this meeting.

The 2nd Best of Elite Ped-GI meeting was dedicated to advancing clinical knowledge and best practices in pediatric gastroenterology and nutrition, with one of the plenary sessions being focused on parenteral nutrition in children with complex gastrointestinal disorders and intestinal failure (IF).

Participants in the panel discussion titled Intestinal Barrier: Beyond Total Parenteral Nutrition (TPN) included Dr. Mohamad Miqdady, Chief of Pediatric Gastroenterology at Sheikh Khalifa Medical City in Abu Dhabi, Dr. Christos Tzivinikos, Professor from Al Jalila Children's Hospital in Dubai, and Pravin Chaturvedi, PhD, Napo's and Jaguar's Chief Scientific Officer and Chair of the Scientific Advisory Board.

The panelists discussed the clinical challenges of pediatric intestinal failure, including microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF), and the significant burden of long-term dependence on parenteral nutrition. The discussion reviewed the scientific rationale for investigating Napo's liquid oral formulation of crofelemer to reduce intestinal fluid losses and discussed the results from pediatric MVID and SBS-IF patients receiving liquid oral crofelemer for >1 year. The findings showed reductions in parenteral support when normalized to body weight and improvements in growth parameters of weight and stature. Panelists also discussed the significant disease heterogeneity and the importance of the ongoing randomized double-blind placebo-controlled crossover study in MVID patients required to support the regulatory requirements for the company

Patients with intestinal failure, including pediatric MVID and pediatric and adults with Type 1 SBS, cannot adequately orally absorb nutrients, electrolytes and fluids, and require lifelong supportive therapy with total parenteral nutrition (TPN) with or without supplemental intravenous fluids, which together comprises 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.

Dr. Tzivinikos, MD DCH FRCPCH MSc CEBP, served as the Chairman of the 2nd Best of Elite Ped-GI meeting, is a Consultant Pediatric Gastroenterologist and Founder of the Pediatric GI Department at Al Jalila Children's Specialty Hospital in Dubai, and is Clinical Associate Professor at Mohammed Bin Rashid University of Medicine and Health Sciences in Dubai.

Dr. Miqdady is the Division Chief of the Pediatric Gastroenterology, Hepatology & Nutrition Division at Sheikh Khalifa Medical City, a flagship tertiary hospital in the UAE and the largest teaching medical center in Abu Dhabi. He is also a Clinical Professor at Khalifa University's medical school in Abu Dhabi, and completed his Fellowship in Pediatric Gastroenterology at Baylor College of Medicine and Texas Children's Hospital in Houston.

Dr. Miqdady is a member of Napo's Scientific Advisory Board. Dr. Miqdady and Dr. Tzivinikos are involved is clinical evaluations of crofelemer powder for oral solution for treatment of IF in pediatric IF patients.

Napo remains sharply focused on its ongoing global development program for oral crofelemer as adjunctive therapy to parenteral support (PS) for rare IF diseases, including MVID and 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.

Napo's pediatric MVID program is expected to provide clinical milestones, which will support its planned New Drug Application (NDA) filing for MVID in mid-2027.

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 Napo's pediatric MVID program will provide clinical milestones which will support its planned New Drug Application (NDA) filing for MVID, and Jaguar's expectation that the company will file a NDA for crofelemer for MVID in mid-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 report about crofelemer in pediatric intestinal failure?

Ongoing investigations in pediatric MVID and SBS-IF patients receiving oral liquid crofelemer for more than one year showed reduced weekly parenteral support needs and support normalized to body weight. Findings also included improved weight and stature, with no significant clinical or laboratory abnormalities.

When does Napo plan to file its MVID New Drug Application?

Napo plans its MVID New Drug Application filing for mid-2027. The company expects its pediatric MVID program to provide clinical milestones supporting that filing.