PR Newswire·Jan 28, 2026, 7:00 AM ET

CalciMedica Announces Discontinuation of Phase 2 KOURAGE Trial in AKI Following Independent Data Monitoring Committee Recommendation

CalciMedica Inc. discontinued its Phase 2 KOURAGE clinical trial evaluating Auxora™ for Stage 2 or 3 acute kidney injury (AKI) with acute hypoxemic respiratory failure (AHRF) following an Independent Data Monitoring Committee (IDMC) recommendation.
The IDMC identified a safety concern warranting reevaluation of the study design, particularly regarding patient enrollment criteria.
No deaths or serious adverse events requiring expedited reporting to the FDA were assessed as related to the study drug.
The company plans to perform a comprehensive review of unblinded clinical data to assess the impact of baseline characteristics, disease severity, concomitant therapies, other factors on patient outcomes.
CEO Rachel Leheny stated that the company remains optimistic about Auxora's potential after treating over 350 critically ill patients in prior trials with no observed treatment-related safety concerns.
CalciMedica intends to finalize the design of a pivotal trial for Auxora in acute pancreatitis in the first half of 2026, pending FDA feedback.
The company is also advancing CM5480 as a potential first-in-class therapy for pulmonary arterial hypertension.
All currently enrolled patients in the KOURAGE trial will complete their full 90-day follow-up period.