CalciMedica announces publication on Kourage trial in AJN

CalciMedica (CALC) announced a publication in the American Journal of Nephrology, or AJN, highlighting the design and rationale of the Company’s Phase 2 KOURAGE trial of lead candidate Auxora in acute kidney injury, or AKI, with respiratory failure. The manuscript, entitled, “Inhibition of Calcium Release-Activated Calcium Channels to Treat Acute Kidney Injury: Design and Rationale of the KOURAGE Study,” was co-authored by Lakhmir Chawla, Clinical Professor of Medicine at University of California San Diego, Chief Medical Officer at ExThera Medical, and Chair of the KOURAGE Steering Committee; Sudarshan Hebbar, Chief Medical Officer of CalciMedica; Glenn Chertow, 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; and other CalciMedica collaborators. The manuscript describes the preclinical and clinical evidence supporting Auxora as a development candidate in AKI with respiratory failure, as well as the rationale for the patient selection and endpoint selection for CalciMedica’s KOURAGE trial. In ischemia/reperfusion models of AKI in rats, Auxora was found to significantly increase glomerular filtration rate and to prevent mortality in Auxora-treated animals versus placebo-treated controls. In the CARDEA trial of patients with severe and critical COVID pneumonia, a post-hoc analysis of a subgroup of 38 patients with AKI at the time of enrollment showed a 62.7% relative reduction and 29.3% absolute reduction in mortality for Auxora versus placebo. Specifically, 7 out of 15 patients on placebo died by day 30 and day 60, as compared to 4 out of 23 patients on Auxora. Patients in KOURAGE will similarly have AKI with respiratory failure and the primary endpoint for the trial is days alive not on a ventilator and not on dialysis.