Calcimedica announces fda clearance of ind application for phase 2 trial of auxora™ for the treatment of severe acute kidney injury
Phase 2 trial, expected to begin in 1h 2024, aims to address the unmet medical need of patients suffering from stage 2 or 3 acute kidney injury with associated acute hypoxemic respiratory failure, a condition associated with a high mortality rate development of auxora in aki is supported by both clinical and pre-clinical evidence, including r esults from recently completed studies in a rat model of aki to be presented at the 29th international acute kidney injury and continuous renal replacement therapy conference in march la jolla, calif. , feb. 13, 2024 /prnewswire/ -- calcimedica, inc. (calcimedica or the company) (nasdaq: calc), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (crac) channel inhibition therapies for acute and chronic inflammatory and immunologic diseases, today 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™, 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).
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