CalciMedica's Auxora IND application receives FDA approval for phase two trial
14 February 2024 -

CalciMedica, Inc. (Nasdaq: CALC), a California-based clinical-stage biopharmaceutical company, announced on Tuesday that it has received clearance for its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for its 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).

CalciMedica expects to initiate the trial, named KOURAGE, in the first half of 2024, with data expected in 2025.

KOURAGE is a randomised, double-blind, placebo-controlled study that will evaluate 150 patients with stage 2 and 3 AKI who have AHRF and are receiving oxygen by non-invasive mechanical ventilation, high flow nasal cannula or intermittent mandatory ventilation (IMV). Patients will be stratified by classification of stage of AKI as well as the use of IMV. Patients will receive either a four-hour infusion of Auxora or placebo at 1.25 mL/kg as a first dose, after which they will receive Auxora or placebo at 1.0 mL/kg at hours 24, 48, 72 and 96.

The primary endpoint of the trial will be evaluation of patients to day 30 to determine days alive, ventilator-free and dialysis-free. Secondary endpoints will include a composite of all-cause mortality, decrease in estimated glomerular filtration rate (eGFR), and the incidence of dialysis over a period of 90 days, also known as MAKE-90 (Major Adverse Kidney Events at 90 days).