Crofelemer

This new IP supports crofelemer's global exclusivity in rare pediatric intestinal failure coincident with published clinical data showing reductions in parenteral support requirements with crofelemer - supporting Jaguar's strategy to secure non-dilutive partnership funding Recent publication by members of Jaguar's Scientific Advisory Board and other intestinal failure key opinion leaders: "Targeted Literature Review and Assessment of Evidence in Microvillus Inclusion Disease (MVID)" SAN FRANCISCO, CA / ACCESS Newswire / November 24, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) today announced that the Australian Patent Office has issued a new patent to Jaguar family company Napo Pharmaceuticals (Napo) for methods for treating short bowel syndrome (SBS), bile acid diarrhea, and diarrhea associated with small intestine resection or gallbladder removal, in patients with an inhibitor of chloride-ion transport such as crofelemer, Jaguar's novel plant-based prescription drug. "This new patent expands the international IP protection supporting crofelemer's development in short bowel syndrome with intestinal failure (SBS-IF)," said Lisa Conte , founder, president, and CEO. "Together with emerging proof-of-concept data showing reductions in parenteral support, this strengthens the foundation for our planned business development efforts to advance crofelemer in rare pediatric intestinal failure disorders." As announced, and as presented November 8, 2025 at the North American Society for Pediatric Gastroenterology , Hepatology and Nutrition (NASPGHAN) Annual Meeting, the initial results of the ongoing and independent proof-of-concept trial of crofelemer in the UAE demonstrate disease progression modification through reduction of total parenteral support (PS) in pediatric intestinal failure patients that ranged from 12 to 37%. Specifically, in the two SBS-IF patients who have completed treatment, the results show crofelemer reduced PS between 12.5 to 15.6% at the highest dose over the 12-week treatment period, together with reduced loose watery stools frequency. For the initial MVID patient who has completed treatment, PS needs were reduced by up to 27% at the highest dose over the initial 12-week treatment period and up to 37% during the extension period upon reinitiation of crofelemer treatment, and showed reduced frequency of loose watery stools. These findings support continued evaluation of crofelemer to reduce PS needs for pediatric intestinal failure patients. "The intestines of patients with intestinal failure due to short bowel syndrome often do not function properly, as is always the case with patients with intestinal failure due to the ultrarare genetic disorder microvillus inclusion disease (MVID). Intestinal failure is a debilitating, lifelong condition that often requires patients to receive life-sustaining fluids, electrolytes and nutrients through intravenous administration, which consists of total parenteral nutrition (TPN) with supplemental intravenous fluids, which together constitute parenteral support (PS). Most intestinal failure patients require PS up to 7 days a week, and sometimes for 20 hours or more per day," Conte said. While crucial for intestinal failure patients, PS is associated with significant toxicities to patients, similar to some toxicities associated with chemotherapy, often causing serious health problems including infections, metabolic complications, liver and kidney function problems - as well as a risk of neurodevelopmental delay. These symptoms may emerge at any time in intestinal failure patients, and often become life-threatening. SBS affects approximately 10,000 to 20,000 people in the US, according to the Crohn's & Colitis Foundation , and it is estimated that the population of SBS patients in Europe is approximately the same size. MVID is a devastating ultrarare pediatric disorder, with an estimated worldwide prevalence of 100-200 patients, characterized by severe malabsorption that requires life-sustaining parenteral support to meet the nutritional, fluid and electrolyte requirements of the child, and for which there are currently no approved treatments. MVID has a lethal natural history along with significant co-morbidities. An article by Pravin Chaturvedi , PhD, Jaguar's Chief Scientific Officer and Chair of the Jaguar and Napo Scientific Advisory Board , Michela Pantaleoni of Jaguar family company Napo Therapeutics in Italy , along with other members of the company's Scientific Advisory Board and intestinal failure key opinion leaders, has been published in Clinical Nutrition Open Science, the official peer-reviewed open-access journal of ESPEN, the European Society for Clinical Nutrition and Metabolism . The article, "Targeted Literature Review and Assessment of Evidence in Microvillus Inclusion Disease (MVID)," synthesizes reported evidence on MVID's clinical manifestations, treatment, and outcomes, highlighting the disease burden and identifying key gaps in current knowledge. In addition to supporting the ongoing IIT in the UAE , Napo is also conducting a placebo-controlled clinical trial of crofelemer in pediatric SBS-IF patients at sites in the US and EU, and a placebo-controlled clinical trial of crofelemer in pediatric MVID patients at sites in the US, EU, and Middle East . The company is also providing crofelemer powder for oral solution for use in two expanded access programs in intestinal failure patients with MVID in the US, and for an IIT of crofelemer to treat intestinal failure in adult SBS-IF patients in the US. As with all potential follow-on indications, Jaguar and Napo prioritize IP protection. Napo currently holds approximately 195 patents and approximately 56 patents pending. To date, crofelemer is the only oral plant-based prescription medicine approved under the FDA's Botanical Guidance, which provides an important additional exclusivity advantage due to the inherent practicalities limiting the pathway by which a generic version of the drug could be produced. 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 (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 www.napopharma.com Napo Therapeutics, visit napotherapeutics.com Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." 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: hello@jaguar.healthJaguar-JAGX SOURCE: Jaguar Health, Inc.

Crofelemer can potentially extend lives of MVID patients - infants and children who face the lethal natural history of the disease Parenteral support reduction of up to 37% is groundbreaking; No approved treatments exist for MVID in any region SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / November 20, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that, in support of a possible expedited approval pathway for crofelemer for treatment of intestinal failure in patients with the ultrarare genetic disorder microvillus inclusion disease (MVID), the company has submitted an amended protocol to the U.S. Food and Drug Administration (FDA) for the company's ongoing placebo-controlled clinical trial of crofelemer in pediatric MVID patients. MVID patients are born without the ability to absorb the basic nutrients of life, and are therefore subject to a lethal natural history and a lifetime of parenteral support which is associated with toxicities and comorbidities. The ability of crofelemer to decrease the volume of parenteral support is potentially life extending for these patients and is thus disease progression modifying. Crofelemer provides an opportunity for improved quality of life, potentially reducing the time MVID patients spend on parenteral nutrition and/or supplemental intravenous fluids by up to 37% a day from what is often up to 20 hours a day, 7 days a week to support the daily electrolyte and nutrient needs of the patient. "In light of the initial groundbreaking results of the investigator-initiated trial (IIT) of crofelemer in the United Arab Emirates for treatment of MVID and in support of our efforts to make crofelemer available to children with MVID as quickly and efficiently as possible, as announced, the company met with the FDA on October 2, 2025 to seek their advice regarding our ongoing clinical trial of crofelemer for MVID treatment. Based on the feedback from the FDA during this meeting, we have proposed an amendment to our protocol for this study and submitted the amended protocol to the FDA for their review. Our expectation is that the amended protocol, along with the results of this study, if positive, will support a faster FDA review and approval of crofelemer for MVID," said Pravin Chaturvedi , PhD, Jaguar's Chief Scientific Officer and Chair of the Jaguar and Napo Scientific Advisory Board . Jaguar has also discussed the potential for approval of crofelemer for MVID with the European Medicines Agency , the EU's equivalent of the FDA, based on a study in potentially a small number of patients given the burden of MVID. "That's how unprecedented crofelemer's mechanism of action and these results are in intestinal failure patients with MVID," said Lisa Conte , Jaguar's founder, president, and CEO. "MVID is a devastating ultrarare pediatric disorder, with an estimated worldwide prevalence of only 100-200 patients, so a trial of crofelemer in just a small number of MVID patients is expected to be statistically meaningful." As presented on November 8, 2025 , at the North American Society for Pediatric Gastroenterology , Hepatology and Nutrition (NASPGHAN) Annual Meeting, the initial groundbreaking results of an ongoing and independent IIT of crofelemer in the UAE for treatment of pediatric intestinal failure, which includes patients with intestinal failure due to MVID and short bowel syndrome (SBS-IF), demonstrate disease progression modification through reduction of total parenteral support (PS) in pediatric intestinal failure patients that ranged from 12 to 37%. For the initial MVID patient who has completed treatment, PS needs were reduced by up to 27% at the highest dose over the initial 12-week treatment period and up to 37% during the extension period upon reinitiation of crofelemer treatment, and also showed reduced frequency of loose watery stools. This finding supports continued evaluation of crofelemer to reduce PS needs for pediatric MVID patients. MVID causes intestinal failure, a situation where the patient's intestines are unable to absorb the fluids, electrolytes and nutrients required to survive and thrive. Intestinal failure is a debilitating, morbid and lifelong condition that often requires patients to receive life-sustaining fluids, electrolytes and nutrients through intravenous administration, which consists of total parenteral nutrition (TPN) with supplemental intravenous fluids, which together constitute parenteral support (PS). Most intestinal failure patients require PS up to 7 days a week, and sometimes for 20 hours or more per day. While crucial for these patients, PS is associated with significant toxicities to patients, similar to some toxicities associated with chemotherapy, often causing serious health problems including infections, metabolic complications, liver and kidney function problems - as well as a risk of neurodevelopmental delay. These symptoms may emerge at any time in intestinal failure patients, and often become life-threatening. In addition to supporting the IIT in the UAE and conducting the placebo-controlled clinical trial of crofelemer in pediatric MVID patients at sites in the U.S. , E.U., and Middle East , the company is also providing crofelemer powder for oral solution for use in two expanded access programs in the U.S. to treat intestinal failure in pediatric patients with MVID. 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 (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 MVID and short bowel syndrome. For more information about: Jaguar Health , visit https://jaguar.health Napo Pharmaceuticals , visit www.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 the amended protocol the company submitted to the FDA for the company's ongoing trial of crofelemer for the treatment of intestinal failure in MVID patients will support a possible expedited approval pathway for crofelemer for this indication, Jaguar's expectation that the ability of crofelemer to decrease the volume of PS is life extending and disease progression modifying for MVID patients, and that crofelemer provides an opportunity for improved quality of life for MVID patients by reducing the time MVID patients spend on parenteral nutrition and/or supplemental intravenous fluids by up to 37% a day, Jaguar's expectation that the amended protocol, along with the results of the company's study, if positive, will support a faster FDA review and approval of crofelemer for treatment of MVID, and Jaguar's expectation that crofelemer could also be approved by the European Medicines Agency for MVID based on a study in potentially a small number of patients. 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: hello@jaguar.health Jaguar-JAGX SOURCE: Jaguar Health, Inc.