LA JOLLA, Calif., May 24, 2017 /PRNewswire/ -- Privately-held CalciMedica, Inc., announced today that it received Fast-track designation from the U.S. Food and Drug Administration (US FDA) for its lead clinical compound, CM4620, a novel, calcium release-activated calcium (CRAC) channel inhibitor, for the treatment of acute pancreatitis. Currently, there are no therapeutic agents approved to treat acute pancreatitis, an inflammatory condition that is the leading cause of gastrointestinal hospitalizations and healthcare cost burden in the US.
“We are very pleased to receive Fast-track designation for CM4620, which may allow us to accelerate clinical development and future regulatory review of this exciting compound,” said Michael Dunn, President of CalciMedica. “We believe CM4620 holds great promise for patients suffering from acute pancreatitis, who have no therapeutic options today other than supportive care. As we complete our Phase 1 safety studies, we look forward to working closely with the FDA and other regulatory bodies to advance CM4620 into patient studies, the first of which is planned to start early next year.”
About Acute Pancreatitis
Acute pancreatitis is an inflammatory condition of the pancreas that currently has no disease-modifying therapy. Its incidence is increasing, as are the costs associated with caring for patients who are all hospitalized for periods of time ranging from days to weeks or months depending on severity. Patients with moderately severe and severe disease, who comprise upwards of 25% of all cases, are afflicted with organ failure of varying duration that can result in significant morbidity and mortality.
About Fast-track Designation
Fast-track designation is awarded to agents that treat a serious condition and fill an unmet medical need. Fast-track designation enables the recipient to have more frequent interaction with and support from the FDA, both through meetings and written communications, and also makes the drug eligible for Accelerated Approval and Priority Review. Accelerated Approval enables the use of surrogate and intermediate clinical endpoints, which can make the clinical trials process more efficient, and Priority Review reduces the stipulated time of FDA review of a new drug application (NDA) from 10 months to 6 months.
About CRAC channels and CM4620
CRAC channels, comprising Orai channel and STIM regulatory proteins, function to maintain proper levels of calcium in most non-excitable cells. In immune cells, particularly T cells, calcium is an important intracellular signaling molecule that controls cytokine production and the immune response. CRAC channels help to control and maintain calcium levels, and dysfunction in this pathway can lead to immune and autoimmune disease. In pancreatic acinar cells, which produce digestive enzymes that are secreted into the intestine where they help digest food, high intracellular calcium resulting from aberrant activation of CRAC channels causes these enzymes to activate prematurely and begin breaking down pancreatic cells, leading to acute pancreatitis.
CalciMedica’s lead compound, CM4620, inhibits the uncontrolled increase in intracellular calcium in pancreatic acinar cells, preventing inappropriate digestive enzyme activation, acinar cell dysfunction and death, or necrosis. CM4620 also inhibits the Icrac pathway in human T cells, blocking the release of pro-inflammatory cytokines like IL-2 and IL-17, and has been shown to reduce neutrophil activation. CM4620 has demonstrated activity in vivo in several animal models of acute pancreatitis, both on pancreatic necrosis and markers of systemic inflammation, like the neutrophil enzyme myeloperoxidase in the lung. Currently, CalciMedica is completing Phase 1 safety studies of CM4620 and plans to advance the program into patient studies early in 2018.
About CalciMedica, Inc.
CalciMedica is a privately-held, clinical stage biopharmaceutical company focused on CRAC channels and leading the discovery and development of novel CRAC channel modulators for the treatment of acute or chronic diseases in which inflammation plays a role. CRAC channels control calcium entry into immune and other cell types. In T cells, calcium signaling is essential for the adaptive immune response, and the CRAC channel has been clinically validated as an important drug target in humans through the use of calcineurin inhibitors that act downstream from CRAC channels. CalciMedica maintains its headquarters in San Diego, CA. For more information, please visit www.calcimedica.com.
Michael Dunn, President