- D-dimer levels have been correlated with disease severity and risk of mortality in patients with COVID-19
- Treatment with Auxora improved D-dimer levels in patients with severe COVID-19 pneumonia
LA JOLLA, Calif., February 2, 2021 – CalciMedica Inc. (“CalciMedica” or the “Company), a clinical-stage biotechnology company targeting calcium release-activated calcium (CRAC) channels for the treatment of severe acute and chronic inflammatory diseases, today announced the presentation of new clinical data from the open-label, placebo-controlled trial of Auxora™ in patients with severe COVID-19 pneumonia. The abstract titled Auxora Improves D-Dimer Levels in Patients with Severe COVID-19 Pneumonia was presented by lead author Charles Bruen, M.D., a critical care and emergency physician at Regions Hospital in St. Paul, Minnesota, at the 50th Critical Care Congress from the Society of Critical Care Medicine (SCCM) taking place virtually from January 31 to February 12, 2021.
In the study, 17 patients with severe COVID-19 pneumonia were randomized to receive Auxora, a potent and selective small molecule CRAC channel inhibitor, plus standard of care and nine patients received standard of care alone. Standard of care at study sites included prophylactic anticoagulation. The data showed that levels of D-dimer, a key marker of clotting and inflammation, decreased in patients receiving Auxora combined with standard of care therapy but increased in patients receiving standard of care alone. In addition, two patients who received standard of care alone developed femoral deep vein thrombosis, with one progressing to a pulmonary embolism, while none of the patients who received Auxora developed thromboembolic disease.
“The clear reduction of D-dimer levels, which have been correlated with disease severity and risk of mortality in patients with COVID-19, with Auxora is very promising,” said Charles Bruen, M.D. “It’s clear that Auxora has strong anti-inflammatory effects that directly or indirectly may play a significant role in preventing potentially devastating complications of COVID-19, including thromboembolic disease. This study also supports the use of D-dimer as a clinical biomarker to quickly and safely assess the efficacy of treatments for COVID-19.”
Sudarshan Hebbar, M.D., chief medical officer of CalciMedica added, “We remain encouraged by the positive results that we have seen from the use of Auxora in severe COVID-19 pneumonia. These new data provide further evidence of the significance of CRAC channel inhibition in preventing inflammation in a number of ways, and we look forward to sharing more data demonstrating the benefits of Auxora in COVID-19 in addition to acute pancreatitis in the coming months.”
Auxora has demonstrated faster recovery and reduced use of invasive mechanical ventilation and death in patients with severe COVID-19 pneumonia as compared to standard of care alone. A blinded, placebo-controlled clinical trial is enrolling up to 400 patients with severe COVID-19 pneumonia to assess Auxora plus standard of care compared to placebo plus standard of care alone. Patients will 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 United States are expected to enroll patients. For more information about the clinical trial, visit clinicaltrials.gov.
Additional details about the presentation can be found at: https://www.sccm.org/Education-Center/Annual-Congress.
About Auxora™ (formerly CM4620-IE)
CalciMedica’s lead clinical compound, Auxora, is a potent and selective small molecule inhibitor of Orai1-containing CRAC channels that is being developed for use in patients with severe COVID-19 pneumonia and in patients with acute pancreatitis and accompanying systemic inflammatory response syndrome. CRAC channels are found on many cell types, including lung endothelium cells, pancreatic acinar cells and immune system cells, where aberrant activation of these channels may play a key role in the pathobiology of acute and chronic inflammatory syndromes. CalciMedica is also exploring other acute indications for Auxora such as viral pneumonia, acute lung injury, acute respiratory distress syndrome and acute kidney injury.
About CalciMedica, Inc.
CalciMedica is a privately held, clinical-stage biotechnology company with a platform focused on CRAC channel drug discovery and development for the treatment of severe acute and chronic inflammatory diseases, including acute pancreatitis, chronic pancreatitis, COVID-19 pneumonia and acute respiratory distress syndrome (ARDS). The company has a portfolio of potent and selective small molecule CRAC channel inhibitors, including its lead product Auxora, that prevent CRAC channel overactivation that can cause organ injury in numerous settings, including endothelial apoptosis, pancreatic necrosis, tissue fibrosis and diffuse alveolar damage. Data from both a Phase 2a acute pancreatitis trial and a Phase 2 COVID-19 pneumonia trial suggest that Auxora prevents organ tissue damage and allows for rapid restoration of organ function. CalciMedica is headquartered in San Diego, CA. For more information, please visit the company website at www.calcimedica.com.
Rachel Leheny, Ph.D.
Chief Executive Officer
Karen O’Shea, Ph.D.