CalciMedica Announces Peer-Reviewed Publication of Positive COVID-19 Data and Initiation of Blinded, Placebo-Controlled Trial of Auxora™ in Patients with Severe COVID-19 Pneumonia
LA JOLLA, Calif., Aug. 18, 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 the publication in the peer-reviewed medical journal Critical Care of results from a randomized, controlled, open-label clinical study showing substantially improved outcomes in patients with severe COVID-19 pneumonia treated with Auxora™. This week, the Company is initiating a blinded, placebo-controlled clinical trial enrolling up to 400 patients with severe COVID-19 pneumonia to assess Auxora plus standard of care compared to placebo plus standard of care.
Auxora, a potent and selective small molecule CRAC channel inhibitor, combined with standard of care therapy showed faster recovery and reduced by over half the use of invasive mechanical ventilation and death in patients with severe COVID-19 pneumonia as compared to standard of care alone. Auxora also demonstrated a favorable safety profile in patients with both severe and critical COVID-19 pneumonia compared to standard of care alone. The manuscript titled “Auxora versus Standard of Care for the Treatment of Severe or Critical COVID-19 Pneumonia: Results from a Randomized Controlled Trial” was co-authored by Charles Bruen, M.D. a critical care and emergency physician at Regions Hospital in St. Paul, Minnesota and Joseph Miller, M.D. a Henry Ford Hospital emergency medicine physician and a principal investigator in the trial. The publication is open access and may be viewed and downloaded at: https://rdcu.be/b6hav.
“We are encouraged by the publication of these results in a peer-reviewed journal as prominent as Critical Care,” said Charles Brue, M.D. “Our results indicate that Auxora in combination with other treatments, including remdesivir and dexamethasone that are becoming the standard of care, could be beneficial to patients suffering from COVID-19 pneumonia. It also suggests that this approach, reducing inflammation and protecting pulmonary endothelium by inhibiting CRAC channels, has distinct advantages in this clinical setting.”
CalciMedica is conducting Part 2 of its clinical trial after receiving U.S. Food and Drug Administration (FDA) clearance of its protocol for the blinded, placebo-controlled stage of the study. Up to 400 patients with severe COVID-19 pneumonia will be randomized 1:1 to receive either Auxora or matched lipid nano-emulsion placebo in addition to standard of care which may include both remdesivir and dexamethasone. Up to 40 sites across the U.S. are expected to enroll patients.
Sudarshan Hebbar, M.D., chief medical officer of CalciMedica, added, “The improved patient outcomes that have been peer-reviewed and published support our moving forward with a large, blinded efficacy trial of Auxora. As the number of COVID-19 cases continues to surge, there is a dire need for a fast-acting therapy that works to preserve oxygenation. Auxora can protect against the pulmonary damage observed in COVID-19 patients and we are eager to assess its effects in combination with standard of care to improve clinical outcomes for patients at clinical sites across the U.S. and particularly those in COVID-19 hot spot areas.”
For more details on the upcoming study please visit clinicaltrials.gov.
About Auxora™ (formerly CM4620-IE)
About CalciMedica, Inc.
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