CalciMedica Begins Phase 2 Trial of Auxora for Acute Kidney Injury and Respiratory Failure

CalciMedica Inc. ("CalciMedica" or the "Company") (NASDAQ:CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses, today announced that the first patient has been dosed in KOURAGE, the Company's Phase 2 trial evaluating Auxora™ for the treatment of severe acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF).

"AKI is a serious condition, causing about 3.7 million hospitalizations annually just in the United States," said Lakhmir Chawla, M.D., Clinical Professor of Medicine at University of California San Diego, Chief Medical Officer at ExThera Medical, and Chair of the KOURAGE Steering Committee. "Disease progression for patients with AKI can occur quickly, and those who reach Stage 2 and Stage 3 AKI face significant risk of mortality and serious morbidities such as respiratory failure. The current standard of care for these patients is limited to supportive therapy. With Auxora, CalciMedica continues to lay the foundation for a potentially revolutionary treatment for an underserved and often fatal disease."

"Auxora has shown promising data in preclinical models and prior human trials which highlight its potential as a therapeutic option for AKI, where none currently exists," said Glenn Chertow, M.D., Norman S. Coplon/ Satellite Healthcare Professor of Medicine, Professor of Epidemiology and Population Health and Health Policy at Stanford Medicine, and Member of the KOURAGE Steering Committee. "In KOURAGE, Auxora will be used to treat patients with established, moderate to severe AKI, and I look forward to reviewing the data in the coming year."

KOURAGE is a randomized, double-blind, placebo-controlled study expected to enroll approximately 150 patients with Stage 2 and 3 AKI who have AHRF and will randomize patients to receive 5 daily doses of Auxora or placebo. The study will assess patients up to day 30 following the final dosing to evaluate the number of days alive without the need for a ventilator or dialysis. The study's secondary endpoints will include a composite measure of all-cause mortality, decline in estimated glomerular filtration rate (eGFR) and the occurrence of dialysis over a 90-day period, also known as MAKE-90 (Major Adverse Kidney Events at 90 days). Topline data from KOURAGE are expected in 2025.

"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," said Sudarshan Hebbar, M.D., Chief Medical Officer of CalciMedica. "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."