The US Food and Drug Administration (FDA) has approved CalciMedica's investigational new drug (IND) application to advance Auxora to a Phase II clinical trial.

The KOURAGE trial will analyse Auxora's ability to treat acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF).

The randomised, placebo-controlled study will enrol 150 subjects with stage two and three AKI who are experiencing AHRF and are on various oxygen delivery methods.

Trial participants will receive an initial four-hour infusion of Auxora or a placebo at a dosage of 1.25ml/kg, followed by subsequent doses of 1.0ml/kg at 24, 48, 72 and 96 hours.

The study's primary endpoint will be to assess patients up to day 30 to evaluate the number of days they are alive without the need for ventilators or dialysis.

Its secondary endpoints will include a composite measure of all-cause mortality, a decline in estimated glomerular filtration rate (eGFR) and the occurrence of dialysis over a 90-day period.

The trial is expected to start in the first half of this year, with data due to be released next year.

CalciMedica CEO Rachel Leheny said: “The IND clearance for the Phase II 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.

“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.”

Auxora is a small molecule inhibitor of Orai1-containing CRAC channels in the development to treat acute inflammatory and immunologic ailments.

CalciMedica previously evaluated Auxora's ability to treat patients with severe and critical Covid-19 pneumonia in the CARDEA trial.

In that trial, the treatment demonstrated a nearly 40% reduction in AKI compared with the placebo group.