Core Insights - CalciMedica Inc. announced the publication of preclinical data and a post-hoc analysis of its lead candidate Auxora™ for treating acute kidney injury (AKI) with respiratory failure, highlighting its potential as a transformative treatment [1][3][5] Company Overview - CalciMedica is a clinical-stage biopharmaceutical company focused on developing novel therapies targeting calcium release-activated calcium (CRAC) channels for inflammatory and immunologic diseases [5][6] - The company’s lead product candidate, Auxora™, has shown positive clinical results in multiple trials and has been well-tolerated in over 350 critically ill patients [5] Clinical Trial Details - The KOURAGE trial is a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of Auxora in patients with severe AKI and respiratory failure, aiming to enroll approximately 150 patients [4] - The primary endpoint of the KOURAGE trial is the number of days alive without the need for a ventilator or dialysis, with secondary endpoints including all-cause mortality and decline in estimated glomerular filtration rate (eGFR) [4] Preclinical and Clinical Evidence - Preclinical models demonstrated that Auxora significantly increased glomerular filtration rate (GFR) and prevented mortality in AKI models [3] - A post-hoc analysis from the CARDEA trial indicated a 62.7% relative reduction and a 29.3% absolute reduction in mortality for patients treated with Auxora compared to placebo [3] Market Context - Approximately 3.7 million patients are hospitalized with AKI in the U.S. annually, with a high mortality risk of around 50% for those with severe AKI and respiratory failure [3]
CalciMedica Announces Publication in the American Journal of Nephrology Discussing Design and Rationale of Phase 2 KOURAGE Trial of Auxora™ in AKI with Respiratory Failure