CalciMedica Enrolls First Patient in Phase 2 KOURAGE Trial of Auxora™ for Severe AKI

CalciMedica Inc., a clinical-stage biopharmaceutical company, has initiated its Phase 2 KOURAGE trial to evaluate Auxora™ in treating severe acute kidney injury (AKI) accompanied by acute hypoxemic respiratory failure (AHRF). This trial marks a significant step in the development of novel calcium release-activated calcium (CRAC) channel inhibition therapies targeting acute and chronic inflammatory and immunologic diseases.

The condition of AKI is severe, leading to approximately 3.7 million hospitalizations each year in the United States alone. Dr. Lakhmir Chawla, a Clinical Professor of Medicine at the University of California San Diego and Chair of the KOURAGE Steering Committee, underscored the critical nature of AKI, noting that progression to Stage 2 and Stage 3 AKI significantly heightens the risks of mortality and severe morbidities, including respiratory failure. Currently, the standard treatment for these patients is limited to supportive therapy, highlighting the urgent need for effective therapeutic options like Auxora.

Glenn Chertow, M.D., a Professor of Medicine at Stanford Medicine and a member of the KOURAGE Steering Committee, emphasized the promising results of Auxora in preclinical and prior human studies. Auxora has shown potential as a therapeutic option for AKI, which currently lacks approved treatments. The KOURAGE trial will focus on evaluating the efficacy of Auxora in patients with moderate to severe AKI. The trial is expected to enroll around 150 patients, who will be randomized to receive either Auxora or a placebo over five days. The primary endpoint will be the number of days patients are alive without the need for mechanical ventilation or dialysis up to 30 days post-treatment. Secondary endpoints include a composite measure of all-cause mortality, decline in estimated glomerular filtration rate (eGFR), and occurrence of dialysis over a 90-day period, known as MAKE-90. The company expects to release topline data from the study in 2025.

Dr. Sudarshan Hebbar, Chief Medical Officer of CalciMedica, highlighted previous findings from the CARDEA trial where Auxora treatment reduced the incidence of AKI and improved survival rates among severe COVID-19 pneumonia patients. These results, along with data from an ischemia reperfusion model of AKI, support Auxora’s potential benefits in improving kidney function and survival outcomes.

Auxora is CalciMedica’s lead clinical compound and is a potent and selective small molecule inhibitor of Orai1-containing CRAC channels. It is designed for use in patients with acute inflammatory and immunologic illnesses. CRAC channels are present in various cell types, including immune cells, endothelial cells, and pancreatic acinar cells, where their abnormal activation is implicated in the development of acute and chronic inflammatory conditions. Auxora is currently under evaluation in several clinical trials, including a Phase 2b trial for acute pancreatitis (AP) with systemic inflammatory response syndrome (SIRS) and an investigator-sponsored Phase 1/2 trial in pediatric patients with asparaginase-induced pancreatic toxicity (AIPT). No approved therapies currently exist for AP, AKI, or AIPT.

The KOURAGE trial is a critical step toward addressing the unmet medical needs of patients with AKI. AKI, characterized by a sudden loss of kidney function, poses significant risks, particularly for patients with advanced stages of the disease. The trial will assess patients on non-invasive mechanical ventilation or other forms of respiratory support and aims to provide evidence supporting Auxora as a therapeutic option for this severe condition.

CalciMedica, founded by scientists from Torrey Pines Therapeutics and the Harvard CBR Institute for Biomedical Research, remains at the forefront of developing innovative CRAC channel inhibition therapies. The company’s proprietary technology aims to modulate immune responses and protect against tissue cell injury, offering potential therapeutic benefits for life-threatening inflammatory and immunologic diseases. Through its ongoing and planned clinical trials, CalciMedica is dedicated to bringing effective treatments to patients with high unmet medical needs.