CalciMedica confirms FDA allows KOURAGE trial dosing to continue
- CalciMedica (NASDAQ:CALC) said the FDA reviewed its Phase 2 KOURAGE trial amendment for Auxora and raised no objections.
- Dosing will continue in patients with acute kidney injury (AKI) and acute hypoxemic respiratory failure (AHRF).
- The program follows a prior temporary pause after a mortality imbalance was flagged by an independent monitoring committee.
CalciMedica (NASDAQ:CALC) reported that the U.S. Food and Drug Administration reviewed a protocol amendment and interim safety data from its Phase 2 KOURAGE trial and provided no comments, allowing dosing to continue.
The trial is evaluating Auxora in patients with Stage 2 and 3 acute kidney injury alongside acute hypoxemic respiratory failure, a high-risk critical care population.
An independent data monitoring committee had previously paused enrollment after observing a mortality imbalance, although no drug-related toxicity was identified during safety reviews.
A safety review of 107 treated patients found serious adverse events consistent with prior Auxora studies, without new safety concerns emerging.
CalciMedica also expects FDA feedback in the third quarter of 2026 regarding a potential pivotal Auxora program in acute pancreatitis.
