CalciMedica Announces that FDA Has Strongly Recommended Moving to a Blinded Placebo-controlled Trial with Auxora™ in Patients with Severe COVID-19 Pneumonia

LA JOLLA, Calif., May 21, 2020 (GLOBE NEWSWIRE) — CalciMedica Inc. (“CalciMedica” or the “Company), a clinical-stage biotechnology company targeting calcium release-activated calcium (CRAC) channels for the treatment of acute and severe inflammatory diseases, today announced that it has received guidance from the U.S. Food and Drug Administration (FDA) regarding the Company’s ongoing study of Auxora™ (formerly called CM4620-IE) in patients with COVID-19 pneumonia. The FDA has strongly recommended that CalciMedica transition from the current randomized open-label study to a blinded placebo-controlled trial as soon as possible. The FDA provided this recommendation following the submission of a recent interim analysis of Auxora in patients suffering from severe COVID-19 pneumonia. The interim analysis was conducted by CalciMedica following an Independent Safety Review Committee (ISRC) recommendation to continue the study.