Privately-held CalciMedica, announced that it received Fast-Track designation from the US 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."
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.