LA JOLLA, CA, October 30, 2019 /PRNewswire/ — Joseph Miller, MD, MS, a physician at the Henry Ford Health System in Detroit, MI, and a key Principal Investigator on CalciMedica’s initial acute pancreatitis clinical study of its calcium release-activated calcium (CRAC) channel inhibitor CM4620-IE (NCT03401109), presented on the study at the annual meeting of the American College of Emergency Physicians being held in Denver, CO from October 27-30. The presentation, titled “An Open-Label, Dose-Response Study of CM4620-Injectable Emulsion (IE) in ED Patients with Acute Pancreatitis” summarized key findings from the study, including reduction in pancreatic inflammation and necrosis by computed tomography (CT), reduced incidence of persistent SIRS, reduced incidence of acute kidney injury, reduced hospital stay and a somewhat unexpected but critical finding – the rapid return of tolerance of solid diet.
Acute pancreatitis can be a very serious, life-threatening disease, for which no disease-modifying therapies are available. Greater than 250,000 patients in the US are annually admitted to the hospital for acute pancreatitis, and all that is typically provided is supportive care – iv fluids and pain medication. These patients typically present to the ER, and the more severe patients often spend time in the ICU. Patients in CalciMedica’s study had acute pancreatitis with accompanying systemic inflammatory response syndrome (SIRS) and mild hypoxemia, a category predicted to be at high risk for a severe course. In addition, acute pancreatitis has multiple etiologies, with the two leading ones being gallstones and alcohol. The majority of patients in the study had the more prevalent gallstone-or alcohol-induced acute pancreatitis, other causes were seen as well, including hypertriglyceridemia and trauma. Patients appeared to respond well to CM4620-IE regardless of the severity or cause of their disease.
Dr Miller said, “I think CM4620-IE holds great promise. Some of the patients at our site were really quite sick, and their response to the drug, especially the rapid return of their desire and tolerance of solid food was remarkable”.
Sudarshan Hebbar, CalciMedica’s Chief Medical Officer, commented “We think this study demonstrates not only the activity of CM4620-IE on a number of different and important disease parameters, but also its safety, as there were no drug-related serious adverse events (SAEs) in a study population that included a preponderance of critically ill patients. Early tolerance of solid diet is also interesting. Physicians that care for these critically ill patients understand that when the patient is able to eat, this is a very favorable sign, as it indicates the inflammation is resolving”.
Dr. Hebbar continued, “We are leveraging these results as we prepare for the next clinical study of CM4620-IE, a Phase 2b trial that will be similar in design to the study presented by Dr. Miller, but significantly expanded in patient numbers. The Phase 2b study will build on all that we have learned about CM4620-IE in acute pancreatitis to date, and will include dose-ranging and efficacy evaluations to position the compound for what we believe will be a successful Phase 3 trial”.
CM4620 is a potent and selective small molecule inhibitor of calcium release-activated calcium (CRAC) channels. CRAC channels are found on many cell types, including immune cells and pancreatic acinar cells, where aberrant activation of these channels is thought to play a key role in the pathobiology of acute pancreatitis. CM4620 arose from CalciMedica’s internal R&D, is patent- protected, and is being developed for patients with acute pancreatitis and accompanying SIRS.
About CalciMedica, Inc.
CalciMedica is a privately-held, clinical stage biotechnology company focused on CRAC channel drug discovery and development for the treatment of acute and chronic inflammatory diseases. CRAC channels control the entry of calcium into immune and other cell types, and calcium is an important intracellular signaling molecule that modulates normal cellular function but can be detrimental when levels are too high. CalciMedica is headquartered in San Diego, CA. For more information, please visit the company website at www.calcimedica.com.
Michael Dunn, President and Chief Operating Officer