The study is one of five clinical efforts - three IIT proof-of-concept studies and two Phase 2 studies - of crofelemer for the rare disease indications of SBS-IF and/or microvillus inclusion disease (MVID), an ultrarare congenital diarrheal disorder, in the US, EU, and/or Middle East/North Africa (MENA) regions; availability of IIT proof-of-concept results potentially in Q2 2025
Crofelemer, Jaguar's novel plant-based prescription drug, has been granted Orphan Drug Designation by the FDA and the European Medicines Agency for both SBS-IF and MVID
SAN FRANCISCO, CA / ACCESSWIRE / December 6, 2024 / Jaguar Health, Inc.(NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that an independent IIT in the U.S. to evaluate the efficacy and safety of crofelemer, Jaguar's novel plant-based anti-diarrheal prescription drug, for the rare disease indication of short bowel syndrome with intestinal failure (SBS-IF) in adults has begun. An overview of the study can be viewed on the ClinicalTrials.gov website.
Lisa Conte, Jaguar's founder, president, and CEO, said, "This study is one of five clinical efforts - three IIT proof-of-concept studies and two Phase 2 studies - of crofelemer for the rare disease indications of SBS-IF and/or MVID in the US, European Union, and/or MENA regions. These studies are evaluating a novel powder formulation of crofelemer for oral solution - which is different from the FDA-approved oral formulation of crofelemer available for people living with HIV/AIDS. Dosing of the first patient in each of these five studies is expected to occur throughout December 2024 and Q1 2025, with availability of IIT proof-of-concept results potentially in Q2 2025. In accordance with the guidelines of specific EU countries, published data from clinical investigations in SBS-IF and MVID could support reimbursed early patient access to crofelemer for these debilitating conditions in those countries."
"SBS-IF and MVID, rare and severe diseases requiring intensive parenteral nutrition (PN) and support, significantly impact the quality of life of both patients and their caregivers," Conte said. "We plan to assess the quality-of-life impact on patients and caregivers as part of both the above-referenced Phase 2 studies."
Some SBS patients are subject to intestinal failure, often requiring PN up to seven days a week. Intestinal failure is associated with significant morbidity and mortality; and high medical expenses associated with PN and coincident complications. SBS patients with intestinal failure also have severe chronic diarrhea, and the associated sequelae, including significant dehydration, metabolic acidosis or alkalosis and malnutrition, and other secondary symptoms. These symptoms may emerge at any time, and many times become life-threatening.
As a congenital diarrheal disorder, MVID is more prevalent in cultures with consanguineous marriage customs. Hence, the importance of the company's relationships with health care professionals in the MENA region, which support and are reflected in the recruiting geography of the trials.
Crofelemer has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for SBS-IF and MVID.
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 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, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo's crofelemer is FDA-approved under the brand name Mytesi® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. 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.
Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that dosing of the first patient in three IITs and two Phase 2 studies of crofelemer will occur throughout December 2024 and Q1 2025, Jaguar's expectation that availability of IIT proof-of-concept results of crofelemer in SBS-IF and/or MVID may potentially occur in Q2 2025, Jaguar's expectation that, in accordance with the guidelines of specific EU countries, published data from clinical investigations could support early patient access to crofelemer for SBS-IF or MVID in these countries, and Jaguar's expectation that it will assess the quality-of-life impact of SBS-IF and/or MVID on patients and caregivers as part of both Phase 2 studies of crofelemer. 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.
