CalciMedica, Inc., a specialist in calcium release-activated calcium (CRAC) channel inhibition therapies for inflammatory and immunologic diseases, called a halt to a Phase II study for its lead drug candidate after an interim safety review.
The California-based firm discontinued the KOURAGE study, assessing small-molecule oral CRAC inhibitor Auxora (CM4620-IE) in patients with Stage 2 or Stage 3 acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF).
The decision was based on an Independent Data Monitoring Committee (IDMC) recommendation based on “a safety concern” that warranted a reconsideration of the current study design and enrollment criteria. The KOURAGE trial was a randomized, double-blind, placebo-controlled Phase II study designed to assess the safety and efficacy of Auxora as a potential treatment for severe AKI with respiratory failure, a condition with high mortality and no approved therapies. The plan was for around 150 patients to receive daily doses of Auxora for five days, with key endpoints including ventilator-free days and avoidance of kidney replacement therapy.
CalciMedica emphasized that the IDMC’s concern centered on aspects of study design and patient enrollment criteria, with no reported deaths or serious adverse events requiring FDA notification linked to Auxora. The firm is planning an evaluation of the unblinded data, focusing on the influence of factors such as baseline characteristics, disease severity, and concomitant therapies, aiming to inform any future AKI study design.
Auxora previously completed Phase II trials for acute pancreatitis (AP) and COVID-19 pneumonia. KOURAGE had previously been expected to yield key data in H1 2026. CalciMedica continues to plan a pivotal trial for the molecule in AP, while a second CRAC inhibitor, CM5480, for pulmonary arterial hypertension is being prepared to enter studies. CalciMedica notified the FDA of the discontinuation and will work with investigators to ensure patient safety and trial completion.