CalciMedica: FDA clears IND application for Phase 2 trial of Auxora

CalciMedica announced the clearance of its Investigational New Drug application by the U.S. FDA for the company’s lead product candidate, Auxora, a potent and selective small molecule inhibitor of Orai1-containing CRAC channels, to be evaluated in a Phase 2 trial in acute kidney injury with associated acute hypoxemic respiratory failure. CalciMedica expects to initiate the trial, named KOURAGE, in the first half of 2024 and data expected in 2025.