"We are very honored to receive this award," said Massimo Radaelli, PhD, Chief Executive Officer of Napo Therapeutics and President of Jaguar International, "as we continue to be laser-focused on our mission of expanding access to crofelemer in Europe for orphan and rare diseases."
In participation with Jaguar and Jaguar family company Napo Pharmaceuticals, Napo Therapeutics is supporting investigator-initiated proof-of-concept (POC) studies of crofelemer for the rare disease indications of microvillus inclusion disease (MVID) and short bowel syndrome (SBS) with intestinal failure in the US, EU, and Middle East/North Africa regions, with results expected by the end of 2024 and throughout 2025. Additionally, a phase 2 trial of crofelemer in adult SBS patients with intestinal failure is expected to initiate before the end of 2024, as is a phase 2 trial of crofelemer in pediatric MVID patients. In accordance with the guidelines of specific EU countries, published data from clinical investigations in such rare diseases could support early patient access to crofelemer for these debilitating conditions in those countries.
Some SBS patients are subject to intestinal failure, often requiring parenteral nutrition (PN) up to 7 days a week. Intestinal failure is associated with significant morbidity and mortality; and high medical expenses associated with PN. SBS patients with intestinal failure also have severe chronic diarrhea, and the associated sequelae from diarrhea, including significant dehydration, metabolic acidosis or alkalosis and malnutrition, and other secondary symptoms, and these symptoms emerge either early or late, and many times become life-threatening.
MVID, an ultrarare congenital diarrheal disorder, is a severe infantile disease characterized by diarrhea, malabsorption, and acid/base instability, requiring intensive parenteral support for nutritional and fluid management, and there are currently no approved drug treatments.
The European, throughout the last decade, has been celebrating achievement, innovation and excellence through its annual awards program. The aim is to give corporate organizations an insight into various achievements within a range of organizations and reward excellence in the global business community. Covering a broad spectrum of business affairs globally, including Energy, Banking and Finance, Foreign Direct Investment, Sustainability, ESG, Shipping, Aviation, Executive Education, Technology, Lifestyle and Business Travel, The European is intended for decision makers around the world and is available through a global distribution network in EMEA, LATAM, North America and Asia.
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, 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 results of investigator-initiated proof-of-concept studies of crofelemer for SBS with intestinal failure and MVID will be available by the end of 2024 and throughout 2025, Jaguar's expectation that a phase 2 trial of crofelemer in adult SBS patients with intestinal failure and a phase 2 trial of crofelemer in pediatric MVID patients will initiate before the end of 2024, and Jaguar's expectation that, in accordance with the guidelines of specific EU countries, published data from such clinical investigations could support early patient access to crofelemer for SBS with intestinal failure or MVID. 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.
