Jaguar Health, Inc. announced initial proof-of-concept results showing that a novel liquid formulation of crofelemer reduced the required TPN and/or supplementary intravenous fluids, collectively referred to as parenteral support (PS) in patients with intestinal failure due to microvillus Inclusion disease (MVID) and short bowel syndrome (SBS-IF) by up to 27% and 12.5% respectively. Based on preliminary communications with European Medicines Agency (EMA) regulatory members that focus on PRIME (Priority Medicines), a program that provides enhanced interactions and early dialogue for development of novel medicines targeting unmet medical needs. Crofelemer may qualify for participation in PRIME in the European Union and potentially in the U.S. Food and Drug Administration's (FDA) Breakthrough Therapies program.
These include statements regarding Jaguar's expectation that the company will host an investor webcast on April 30, 2025, Jaguar's expectation that crofelemer's novel antisecretory mechanism of action may have the potential to provide a novel therapeutic option to modify disease progression through reduction in TPN needs and associated comorbidities in patients with intestinal failure due To MVID, SBS and other dehydrating conditions and improve their quality of life, Jaguar's expectation that a third IIT of crofelemer will initiate in the second half of 2025, Jaguar's expectation that additional POC results from IITs will be available throughout 2025 and will provide additional preliminary data on the safety and potential effectiveness of crofelemer for these highly unmet clinical needs, Jaguar's expectation that, if even just a very small number of MVID patients show benefit with crofelemer, this may potentially allow pathways for regulatory approval in the U.S. and other regions for crofelemer for MVID and SBS-IF and qualify crofelemer for the US.
