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CalciMedica Discontinues Phase 2 Of Auxora Study Following IDMC Review, Stock Tanks

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us

CalciMedica, Inc. (CALC), Wednesday announced the discontinuation of its Phase 2 KOURAGE clinical trial following a recommendation from the trial's Independent Data Monitoring Committee, which identified a safety concern prompting a reevaluation of the study design, especially the patient enrollment criteria.

The study evaluated Auxora in patients with Stage 2 or Stage 3 acute kidney injury with associated acute hypoxemic respiratory failure.

CEO Rachel Leheny commented, "To date, no treatment-related safety concern has been observed across more than 350 critically ill patients treated with Auxora in completed clinical trials, including the Phase 2b CARPO trial in acute pancreatitis (AP) and the Phase 2 CARDEA trial in severe COVID-19 pneumonia."

Following the recommendation, the company has discontinued the trial and plans to perform a comprehensive review, assessing the impact of baseline characteristics, disease severity, concomitant therapies, and other factors on patient outcomes.

CalciMedica aims to finalize the design of a pivotal trial in acute pancreatitis in the first half of 2026.

Currently, CalciMedica's stock is plummeting 83.17 percent or $4.24, to $0.88 on the Nasdaq.

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