CalciMedica has dosed the first patient in the Phase II KOURAGE trial of Auxora for treating severe acute kidney injury (AKI) accompanied by acute hypoxemic respiratory failure (AHRF).

CalciMedica’s new therapy, Auxora, is a potent and selective inhibitor of Orai1-containing, calcium release-activated calcium (CRAC) channels.

AKI can occur due to various serious health issues, including infections and trauma.

The KOURAGE trial is a double-blind, randomised, placebo-controlled study that plans to enrol approximately 150 patients with Stage II and III AKI who also have AHRF.

Patients in the trial will be randomised to receive either five daily doses of Auxora or a placebo.

The primary focus of the study is to determine the number of days patients can live without the need for ventilators or dialysis up to 30 days post-treatment.

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Secondary endpoints include a composite measure of mortality, decline in kidney function, and the incidence of dialysis over a 90-day period, referred to as MAKE-90.

CalciMedica chief medical officer Sudarshan Hebbar said: “Our CARDEA trial revealed that treatment of severe and critical Covid-19 pneumonia patients with Auxora reduced the reported incidence of AKI and improved the survival of patients with kidney disease.

“We demonstrated the potential benefits of Auxora in an ischemia reperfusion model of AKI that showed that the therapeutic treatment of AKI with Auxora improved kidney function as measured by estimated glomerular filtration rate and enhanced survival.

“These results were presented at the 29th International Conference on Advances in Critical Care Nephrology that was held in March of this year. These data contribute to the growing body of evidence supporting Auxora as a potential treatment for various acute and critical illnesses.”

Auxora is currently being assessed in a Phase IIb trial for acute pancreatitis (AP) with accompanying systemic inflammatory response syndrome (SIRS), called CARPO, as well as investigator-sponsored Phase I/II trial, called CRSPA.

In April 2024, CalciMedica completed patient enrollment for its Phase IIb CARPO clinical trial, which is evaluating the efficacy of Auxora in treating acute pancreatitis.