Proof-of-concept studies of crofelemer in patients with short bowel syndrome (SBS) with intestinal failure or congenital diarrheal disorders planned for 2023
SAN FRANCISCO, CA / ACCESSWIRE / May 1, 2023 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today announced that Napo Therapeutics, the corporation Jaguar established in Italy in 2021 that focuses on expanding access to the Company's oral botanical drug crofelemer for orphan and rare diseases in Europe, is a Platinum Sponsor of the 9th Annual Elite Ped-GI Congress, which takes place May 4-6, 2023 in Abu Dhabi in the United Arab Emirates.
The Annual Elite Ped-GI Congress is designed to provide information about high level, clinically significant updates and comprehensive trends relevant to the practice of pediatric gastroenterological, nutrition and liver disorders.
"In 2023, as previously announced, Jaguar and Napo Therapeutics plan to support third-party investigator-initiated proof-of-concept (POC) studies of crofelemer in patients with short bowel syndrome (SBS) with intestinal failure or congenital diarrheal disorders (CDD), focused on obtaining POC data showing reduction of requirements of parenteral support, including parenteral nutrition and/or IV fluids," said Lisa Conte, Jaguar's president and CEO. "In accordance with the guidelines of specific European Union countries, publications of data from POC trials could support participation in early patient access programs for crofelemer for SBS or CDD, potentially in 2024, especially for patients with intestinal failure requiring parenteral support. Participation in early access programs, which do not exist in the United States, provides an opportunity for reimbursement while impacting the morbidity and high cost of care for these chronic unmet needs."
SBS affects approximately 10,000 to 20,000 people in the EU and similar prevalence is reported for the U.S. Despite limited treatment options, the global adult and pediatric SBS market alone exceeded $568 million in 2019 and is expected to reach $4.6 billion by 2027, according to a report by Vision Research Reports.
As previously announced, crofelemer has been granted Orphan Drug Designation by the U.S. Food and Drug Administration and the European Medicines Agency for SBS and microvillus inclusion disease (MVID), a rare pediatric CDD condition.
About the Elite Ped-GI Congress
This Elite Ped-GI Congress is designed to provide information about high level, clinically significant updates and comprehensive trends relevant to the practice of pediatric gastroenterological, nutrition and liver disorders. The annual event provides a venue for healthcare professionals to share their best practices, to network within groups of interest, and to create and strengthen clinical collaborations. Additional information about the Elite Ped-GI Congress can be viewed here on the event website.
About Jaguar Health, Napo Pharmaceuticals, Napo Therapeutics & Jaguar Animal Health
Jaguar Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel, plant-based, sustainably derived prescription medicines for people and animals with GI distress, including chronic, debilitating diarrhea. Jaguar Health's wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human pharmaceuticals from plants harvested responsibly from rainforest areas. Our crofelemer drug product candidate is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy. Jaguar Health is the majority shareholder of Napo Therapeutics S.p.A. (f/k/a Napo EU S.p.A.), an Italian corporation established by Jaguar Health in Milan, Italy in 2021 that focuses on expanding crofelemer access in Europe. Jaguar Animal Health is a tradename of Jaguar Health.
For more information about Jaguar Health, please visit https://jaguar.health. For more information about Napo Pharmaceuticals, visit www.napopharma.com. For more information about Napo Therapeutics, visit napotherapeutics.com.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements." These include statements regarding the expectation that Jaguar and Napo Therapeutics will support third-party investigator-initiated POC studies of crofelemer in patients with SBS with intestinal failure or CDD in 2023, and the Company's expectation that publications of data from POC trials could support participation in early patient access programs for crofelemer for SBS or CDD, potentially in 2024, especially for patients with intestinal failure requiring parenteral support. 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.
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SOURCE: Jaguar Health, Inc.
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