#United States #La Jolla #CalciMedica #Auxora #KOURAGE

CalciMedica Discontinues Phase 2 KOURAGE Trial for AKI

On January 28, 2026, CalciMedica Inc. (Nasdaq: CALC), a clinical-stage biopharmaceutical company specializing in innovative therapies for inflammatory and immunologic conditions, made a significant announcement regarding the cessation of its Phase 2 KOURAGE clinical trial. This trial focused on the evaluation of Auxora™, a promising treatment for patients diagnosed with Stage 2 or Stage 3 acute kidney injury (AKI) who also experienced acute hypoxemic respiratory failure (AHRF), a cohort known for high mortality rates and limited treatment options.

The decision to halt the trial was made after an interim data review by the Independent Data Monitoring Committee (IDMC), which flagged a safety concern necessitating a reevaluation of the study design, particularly concerning the criteria for patient enrollment. Crucially, none of the reviewed deaths in the trial were linked to the Auxora treatment or placebo, and no serious adverse events were reported that required rapid notification to the U.S. Food and Drug Administration (FDA).

Dr. Rachel Leheny, CEO of CalciMedica, addressed the issue, assuring that the company would conduct a thorough review of the unblinded clinical data to assess various factors such as baseline characteristics, disease severity, and concurrent therapies that may affect patient outcomes. This comprehensive analysis is expected to inform the direction of future clinical assessments of Auxora in AKI cases. Dr. Leheny commented, “We plan to utilize the feedback from the IDMC to revisit the KOURAGE data and possibly modify the trial's design, specifically the patient enrollment parameters, to support further evaluations of Auxora’s efficacy against AKI.”

As of now, no safety issues attributed to Auxora have been observed across over 350 critically ill patients previously treated in other clinical trials, including the Phase 2b CARPO trial for acute pancreatitis and the Phase 2 CARDEA trial for severe COVID-19 pneumonia. Despite this setback, CalciMedica continues to harbor optimism regarding Auxora's potential in treating acute inflammatory conditions.

The company intends to finalize the design for a pivotal trial on Auxora in acute pancreatitis, pending feedback from the FDA, within the first half of 2026. Additionally, CalciMedica is advancing another CRAC channel inhibitor, CM5480, as a potential first-in-class therapy targeting pulmonary arterial hypertension, supported by promising preclinical results related to pulmonary vascular remodeling and right ventricular function.

In response to this trial discontinuation, CalciMedica has duly informed the FDA and will collaborate with investigators to ensure that all participants in the study complete their full 90-day follow-up care.

About CalciMedica

CalciMedica is dedicated to pioneering CRAC channel inhibition therapies for inflammatory and immunologic diseases. The company focuses on employing its proprietary technology to modulate immune responses and prevent tissue injury in severe and life-threatening conditions, addressing significant unmet medical needs. Auxora™, CalciMedica's leading candidate, is backed by encouraging clinical results from various completed studies, and the company remains at the forefront of developing innovative therapies for critical health issues.

For further information on CalciMedica and its advancements, visit www.calcimedica.com.