CalciMedica, Inc. (CALC), a clinical-stage biopharmaceutical company, on Monday announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for the company's lead product candidate, Auxora.
Auxora is a potent and selective small molecule inhibitor of Orai1-containing CRAC channels, to be evaluated in a Phase 2 trial in acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF).
CalciMedica expects to initiate the trial, named KOURAGE, in the first half of 2024 and data expected in 2025.
"The IND clearance for the Phase 2 trial of Auxora in severe AKI is a significant milestone for CalciMedica as we work towards addressing the serious unmet medical need faced by patients suffering from this condition," said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. "Through KOURAGE, we aim to determine how Auxora can benefit patients with severe AKI and potentially reduce the high mortality rate associated with this disease."
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