CalciMedica Secures FDA Acceptance to Resume Auxora Dosing After KOURAGE Safety Review
CALC•FDA completed a 60-day review of CalciMedica’s Phase 2 KOURAGE trial amendment and safety data from 107 AKI patients and raised no comments, enabling Auxora dosing to continue. After pausing enrollment in January over a mortality imbalance flagged by the IDMC, CalciMedica found no drug-related toxicity and updated inclusion criteria.
1. FDA Review Clears KOURAGE Trial Amendment
The FDA completed its 60-day review of CalciMedica’s IND amendment and safety data from 107 patients in the Phase 2 KOURAGE trial for AKI with AHRF, raised no questions and did not impose a clinical hold, allowing Auxora dosing to resume.
2. Pause Justified By Disease Imbalances Not Drug Toxicity
CalciMedica voluntarily paused enrollment in January after the IDMC noted a mortality imbalance; comprehensive internal and external reviews found no evidence of drug-related toxicity and revealed baseline disease severity differences, prompting refined inclusion criteria and stratification in the March amendment.
3. Future Development Plans Include Pancreatitis Program
CalciMedica anticipates FDA feedback in third quarter 2026 on its planned pivotal program evaluating Auxora in acute pancreatitis and continues to advance CM5480 toward an IND submission in mid-2027 for chronic pulmonary hypertension.
