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Jaguar Health, Inc.

October 18, 2023
Franciscan C
Jaguar Health is a commercial stage pharmaceuticals company that develops novel, plant-based, sustainably derived prescription medicines for GI distress. Our Mytesi® (crofelemer) product (tablet) is FDA-approved for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Our key near-term clinical activity is our ongoing Phase 3 pivotal OnTarget trial of crofelemer for our core follow-on indication of prophylaxis of cancer therapy-related diarrhea (CTD). Enrollment in this pivotal trial completed in May 2023 and top line results are expected to be available in late October 2023. The trial is evaluating the effectiveness of crofelemer's novel mechanism of action – the modulation of two chloride ion channels in the gastrointestinal tract – to mitigate or substantially reduce chronic cancer therapy-related diarrhea. Jaguar's expectation is that this placebo-controlled trial will provide evidence that diarrhea associated with targeted cancer therapies is chronic, not acute, and impacts the patient's ability to remain on their cancer therapy regimens at proven doses for better outcomes. Each year, according to the CDC, more than 1 million cancer patients receive chemotherapy or radiation in an outpatient oncology clinic in the U.S. Treatment can last for months to years, in both the curative and metastatic situations. Crofelemer is currently approved for a chronic use in HIV/AIDS patients, providing a potential opportunity for a paradigm shift for prophylaxis of CTD compared to the management of severe chronic diarrhea with constipating agents such as antimotility drugs, which are predominantly opioids. The company's second prioritized clinical program centers around the evaluation of crofelemer for short bowel syndrome (SBS) with intestinal failure and for microvillus inclusion disease (MVID), a rare congenital diarrheal disorder (CDD). SBS with intestinal failure and MVID are devastating and often catastrophic diseases for patients, who are frequently on parenteral nutrition for as long as 20 hours a day, seven days a week. Jaguar plans to support investigator-initiated proof-of-concept studies of crofelemer in patients with SBS with intestinal failure or MVID, focused on obtaining proof-of-concept (POC) of reduction of requirements of parenteral support including parenteral nutrition and/or intravenous fluids. In accordance with the guidelines of specific European Union countries, publications of POC data from these trials could support early patient access to crofelemer for SBS with intestinal failure or MVID through programs in Europe, possibly in 2024. Early access programs are revenue generating, and reimbursable for participating patients. Crofelemer has been granted Orphan Drug Designation for SBS and MVID by both the FDA and the European Medicines Agency.
Lisa Conte - Jaguar Health, Inc.