CalciMedica has received the US Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application for the Phase 2 trial of Auxora in the treatment of severe acute kidney injury (AKI).

Auxora is a selective intravenous-formulated small molecule inhibitor of Orai1-containing calcium release-activated calcium (CRAC) channels. It is being developed for patients with acute inflammatory and immunologic diseases.

The Phase 2 trial will assess Auxora with associated acute hypoxemic respiratory failure (AHRF).

US-based CalciMedica anticipates starting the trial, dubbed KOURAGE, in the first half of this year, and data is expected by next year.

KOURAGE is a randomised, double-blind, placebo-controlled trial that will assess 150 patients with stage 2 and 3 AKI.

These patients should have AHRF and are getting oxygen by non-invasive mechanical ventilation, high-flow nasal cannula, or intermittent mandatory ventilation (IMV).

The individuals will be categorised as per their acute kidney injury stage and whether IMV is being used. Patients will first get a 1.25 mL/kg infusion of Auxora or a placebo over four hours.

Thereafter, they will receive 1.0 mL/kg infusions of Auxora or a placebo over hours 24, 48, 72, and 96.

CalciMedica said the assessment of patients through day 30 to ascertain days alive, ventilator-free, and dialysis-free will be the primary endpoint of the trial.

CalciMedica CEO Rachel Leheny said: “The IND clearance for the Phase 2 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.”

CalciMedica’s CARDEA trial, which evaluated the CRAC channel inhibitor in patients with severe and critical Covid-19 pneumonia, showed a 40% reduction in reported AKI in Auxora-treated patients as compared to placebo-treated patients.