The Fort Worth Press - Additional Infant Patient to Receive Jaguar Health's Crofelemer for Compassionate Use for Treatment of Intestinal Failure (IF) Due to Microvillus Inclusion Disease (MVID)

SAN FRANCISCO, CA / ACCESS Newswire / July 22, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) today announced that Jaguar family company Napo Pharmaceuticals (Napo) is providing the company's novel crofelemer powder for oral solution for treatment of intestinal failure (IF) due to microvillus inclusion disease (MVID) in an infant in the European Union (EU) for compassionate use.

As announced, Napo has previously provided crofelemer powder for oral solution to treat select infant and pediatric IF patients with MVID in relevant expanded access programs in the U.S. under Single-Patient Investigational New Drug (sIND) applications for physicians assuming direct medical responsibility. Napo has also provided crofelemer powder for oral solution for use in the ongoing investigator-initiated proof-of-concept trial in pediatric patients with IF due to MVID and short bowel syndrome (SBS-IF) in the United Arab Emirates.

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 demonstrate substantial reductions of PS and 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. To put this in context, even a 5-10% reduction is typically considered clinically relevant.

IF patients, 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 parenteral support (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, often fatal complications.

"Napo remains committed to supporting physicians who determine that the unmet medical need for their specific pediatric IF patients could be mitigated through the use of our novel crofelemer formulation as an investigational medicinal product (IMP) for treatment of MVID disease progression as adjunctive oral therapy," said Pravin Chaturvedi, PhD, Napo's and Jaguar's Chief Scientific Officer and Chair of the Scientific Advisory Board. "We wish these physicians and their patients the best outcomes and are grateful for their collaboration. Liquid oral crofelemer as adjunctive therapy to PS has been well tolerated with no significant clinical or laboratory abnormalities throughout the ongoing treatment period of >12 months in selected pediatric IF patients with MVID or SBS in an ongoing clinical study discussed at ESPGHAN 2026. In addition, the reductions in weekly PS requirements normalized to body weight with excellent tolerability support the continued development of liquid oral crofelemer as the first oral adjunctive therapy for pediatric IF patients receiving lifelong PS."

"We're very pleased to be able to make our novel liquid oral formulation of crofelemer available to this infant in the EU through this compassionate use pathway, particularly since infants are not eligible for the enrollment criteria of our blinded trial," said Lisa Conte, Jaguar's founder, president, and CEO. "The patient's physician learned about crofelemer based on heightened awareness of the drug following ESPGHAN 2026."

"We remain sharply focused and committed to our global IF development program for our novel liquid oral crofelemer formulation as adjunctive treatment for the management of rare disorders such as MVID and SBS," Conte said. "Our IF program is expected to continue to provide clinical milestones and is the subject of business development discussions with the potential to bring in non-dilutive funds from potential licensee partners. If appropriate, Jaguar plans to apply for Breakthrough Therapy Designation for crofelemer for the indication of MVID, with a planned filing of an NDA (New Drug Application) with the U.S. Food and Drug Administration (FDA) for this indication in mid-2027. We have completed enrollment in our ongoing blinded pivotal clinical trial of the novel liquid oral formulation of crofelemer in pediatric MVID patients. Data from this trial will serve as the basis for the planned Breakthrough Therapy Designation application and the planned NDA filing, along with data from the use of crofelemer in individual patients under compassionate use. Because MVID is a devastating ultrarare pediatric disorder with a lethal natural history - and an estimated worldwide prevalence of only 200 patients - a trial of crofelemer in just a small number of MVID patients is expected to be statistically meaningful."

One e-poster was presented on June 27, 2026 at ESPGHAN titled Exploratory Single-Arm, Open-Label Non-Randomized Trial Evaluating the Safety and Effectiveness of Crofelemer in Pediatric Patients with Intestinal Failure, and the associated abstract can be viewed by clicking here.

Another report of the evaluation of novel liquid oral crofelemer adjunctive therapy, for the treatment of IF in an infant through an ongoing expanded access program in the U.S., was presented for e-poster viewing at ESPGHAN 2026. The study demonstrated that total daily parenteral nutrition volume and caloric delivery remained stable throughout crofelemer therapy despite ongoing growth, while stool output was simultaneously reduced. The abstract, titled Crofelemer for Symptom Management in Microvillus Inclusion Disease: A Case Report in an Infant, can be viewed by clicking here.

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 its intestinal failure program will continue to provide clinical milestones, Jaguar's expectation that the opportunity may exist to bring in non-dilutive funds from potential licensee partners to support the intestinal failure program, Jaguar's plans to pursue Breakthrough Therapy designation for crofelemer for the indication of MVID, Jaguar's expectation that the company will file an NDA with the FDA for the MVID indication in mid-2027, and Jaguar's expectation that a trial of crofelemer in a small number of MVID patients may be statistically meaningful. 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:

[email protected]
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

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S.Weaver--TFWP