CalciMedica announced that the first patients in a Phase 2a clinical study for acute pancreatitis have been dosed with its proprietary calcium release-activated calcium (CRAC) channel inhibitor CM4620. The study is intended to provide safety and tolerability data on CM4620 in acute pancreatitis patients with accompanying systemic inflammatory response syndrome (SIRS), as well as provide potential indications of beneficial effects. In some acute pancreatitis patients, including those with SIRS, this can be a very serious disease with significant morbidity and mortality; there is no available therapy other than supportive care.
The study is open-label in design, and is being conducted in the US at several sites. It will evaluate two dose levels of CM4620 versus supportive care alone. Sudarshan Hebbar, MD, Chief Medical Officer at CalciMedica, said “We are very excited to test this compound in patients after our successful Phase 1 studies. CM4620 offers a novel mechanistic approach to an illness with high medical need, especially in those patients with moderate and severe disease. We feel it has the potential to address many of the key features of acute pancreatitis in these types of patients, including pancreatic necrosis, systemic inflammation and organ failure, and potentially pain.” Dr Hebbar added, “An important aspect of the study is early treatment of patients, similar to what is done in heart attack or stroke. We believe that by interrupting the disease process before it has advanced too far, we will see stronger effects of the compound. This should be reflected in reduced severity, quicker recovery and shorter hospital stays. We are looking forward to the results.”