CalciMedica Discontinues Phase 2 Clinical Trial of Auxora
CalciMedica announced the discontinuation of its Phase 2 KOURAGE clinical trial evaluating Auxora in patients with Stage 2 or Stage 3 acute kidney injury, or AKI, with associated acute hypoxemic respiratory failure, or AHRF, a population characterized by high mortality and a lack of approved therapies. The decision follows a recommendation from the trial's Independent Data Monitoring Committee, or IDMC. During a prescheduled interim data review, the IDMC identified a safety concern that, in its view, warrants reevaluation of the study design, particularly with respect to patient enrollment criteria. There were no deaths in the trial that were assessed by investigators or CalciMedica as being related to study drug. In addition, no serious adverse events met the criteria for expedited reporting to the FDA. Based on the IDMC's recommendation, the Company has discontinued the trial and plans to perform a comprehensive review of the unblinded clinical data. The Company will assess the impact of baseline characteristics, disease severity, concomitant therapies, and other factors on patient outcomes. These analyses are expected to inform how future clinical evaluation of Auxora in AKI may proceed. The Company has notified the FDA about the trial discontinuation and will work with investigators to ensure all patients currently enrolled in the trial complete the full 90-day follow-up.
