CalciMedica Announces Peer-Reviewed Publication of Positive COVID-19 Data & Initiation of Blinded, Placebo-Controlled Trial

CalciMedica Inc. recently 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, MD, a critical care and emergency physician at Regions Hospital in St. Paul, MN, and Joseph Miller, MD, 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 Bruen, MD. “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 US 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 US are expected to enroll patients.

Sudarshan Hebbar, MD, 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 US and particularly those in COVID-19 hot spot areas.” For more details on the upcoming study please visit clinicaltrials.gov.

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 (SIRS). 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 (ALI), acute respiratory distress syndrome (ARDS), and acute kidney injury (AKI).

CalciMedica is a privately held, clinical-stage biotechnology company with a platform focused on CRAC channel drug discovery and development for the treatment of acute and severe inflammatory diseases. The company was founded in 2007 by Ken Stauderman, CalciMedica’s Chief Scientific Officer, and colleagues at Torrey Pines Therapeutics in San Diego and Harvard’s Center for Blood Research in Cambridge, MA. Dr. Stauderman’s work includes the discovery of the role of STIM1, which works in concert with Orai1 in the CRAC channels targeted by CalciMedica’s drugs. The company has a portfolio of highly selective CRAC channel inhibitor drugs that it is developing to improve outcomes for patients with acute inflammatory indications. It has also assembled a portfolio of patents and patent applications covering those compounds and their use, as well as different aspects of CRAC channel biology. CalciMedica is headquartered in San Diego, CA. For more information, visit www.calcimedica.com.