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CalciMedica Announces FDA Clearance of IND Application for Phase 2 Trial of Auxora™ for the Treatment of Severe Acute Kidney Injury
Phase 2 trial, expected to begin in 1H 2024, aims to address the unmet medical need of patients suffering from stage 2 or 3 acute kidney injury with
About this update from Calcimedica, Inc.
Phase 2 trial, expected to begin in 1H 2024, aims to address the unmet medical need of patients suffering from stage 2 or 3 acute kidney injury with associated acute hypoxemic respiratory failure, a condition associated with a high mortality rate Development of Auxora in AKI is supported by both clinical and pre-clinical evidence, including results from recently completed studies in a rat model of AKI to be presented at the 29th International Acute Kidney Injury and Continuous Renal Replacement Therapy Conference in March LA JOLLA, Calif. , Feb. 13, 2024 /PRNewswire/ -- 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 diseases, today announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for the Company's lead product candidate, Auxora™, a potent and selective small molecule inhibitor of Orai1-containing CRAC channels, to be evaluated in a Phase 2 trial in acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF). CalciMedica expects to initiate the trial, named KOURAGE, in the first half of 2024 and data expected in 2025. "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," said Rachel Leheny , Ph.D., Chief Executive Officer of CalciMedica . "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." AKI is classified as stages 1, 2 and 3 depending on the degree of kidney injury. In the presence of AHRF, stage 2 and stage 3 AKI, both classified as severe, put patients at a 50% or greater risk for death while hospitalized and in the 90 days after discharge.1 Survivors of severe AKI may develop or progress to chronic kidney disease, leading to an eventual need for dialysis. There are approximately 1.1 million patients in the United States suffering from stage 2 and 3 AKI over half of whom have associated AHRF. There are currently no approved therapies for AKI. KOURAGE is a randomized, double-blind, placebo-controlled study that will evaluate 150 patients with stage 2 and 3 AKI who have AHRF and are receiving oxygen by non-invasive mechanical ventilation, high flow nasal cannula or intermittent mandatory ventilation (IMV). Patients will be stratified by classification of stage of AKI as well as the use of IMV. Patients will receive either a four-hour infusion of Auxora or placebo at 1.25 mL/kg as a first dose, after which they will receive Auxora or placebo at 1.0 mL/kg at hours 24, 48, 72 and 96. The primary endpoint of the trial will be evaluation of patients through day 30 to determine days alive, ventilator-free and dialysis-free. Secondary endpoints will include a composite of all-cause mortality, decrease in estimated glomerular filtration rate (eGFR), and the incidence of dialysis over a period of 90 days, also known as MAKE-90 (Major Adverse Kidney Events at 90 days). "The rationale for and design of our Phase 2 KOURAGE study is supported by our prior clinical trials and pre-clinical studies that have indicated the potential benefits of Auxora for the treatment of AKI," said Sudarshan Hebbar , M.D., Chief Medical Officer of CalciMedica . "After the learnings from 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 confirmed this potential benefit of Auxora in specific animal models of AKI. Currently, there are no drugs that treat AKI, and through KOURAGE, we hope to demonstrate that treatment with Auxora translates into a treatment option for this critical acute disease." AKI is a common consequence of severe COVID-19 pneumonia and in CalciMedica's CARDEA trial, which studied Auxora in patients with severe and critical COVID-19 pneumonia, results showed a nearly 40% reduction in reported AKI in Auxora-treated patients as compared to placebo-treated patients. In a post-hoc analysis of CARDEA patients with compromised kidney function (eGFR