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Jaguar Health

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Company/Organization Description or Summary

In 2021, Jaguar Health and its subsidiary Napo Pharmaceuticals established Napo Therapeutics, an Italian corporation focused on rare GI disorders and developing crofelemer, a novel ion channel modulator, for the management of short bowel syndrome (SBS) with intestinal failure. We are seeking a partner in the US and other territories, ex EU, to collaborate in its development. Crofelemer received orphan drug designation (ODD) in the US for SBS in 2017. In December 2021, the European Medicines Agency also granted ODD for crofelemer for SBS based both on epidemiological data for the incidence and prevalence of SBS in the EU as well as the role of crofelemer on the pathophysiology of SBS which supports the physiologic mechanistic rationale for the drug’s use in SBS. A patient case study titled "Improved Electrolyte and Fluid Balance Results in Control of Diarrhea with Crofelemer in Patient with Short Bowel Syndrome: A Case Report," was published May 9, 2022, in the Journal of Clinical Gastroenterology and Treatment. Napo Therapeutics is supporting an investigator-initiated proof-of-concept study in SBS with expected preliminary results at the end of 2022/early 2023 using a highly concentrated liquid reconstitution from lyophilized crofelemer, the anticipated commercial formulation for SBS. Jaguar is a commercial stage public pharmaceuticals company (NASDAQ: JAGX) focused on novel, plant-based, non-opioid, and sustainably derived prescription medicines for people and animals with GI distress, and its marketed product, Mytesi® (a distinct delayed release formulation from the anticipated SBS formulation of crofelemer), for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Crofelemer is the subject of Napo Pharmaceuticals’ OnTarget pivotal Phase 3 clinical trial for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy. Potential expansion indication for crofelemer: Inflammatory Bowel Disease.