CalciMedica announced that the Food and Drug Administration (FDA) has granted a Fast Track designation for CM4620 for the treatment of acute pancreatitis.

Acute pancreatitis is an inflammatory condition that is becoming more prevalent in the U.S., and is currently the leading cause of gastrointestinal hospitalizations across the country. To date, there are no approved agents for the treatment of acute pancreatitis. 

In Phase 1 safety studies, CM4620 showed positive activity in vivo in several animal models. CalciMedica plans to begin the first of its patient studies early in 2018. 

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CM4620 is a novel calcium release-activated calcium (CRAC) channel inhibitor aimed to regulate calcium levels in immune cells and pancreatic cells. By preventing the accumulation of excess intracellular calcium, CM4620 inhibits inappropriate pancreatic digestive enzyme activation, acinar cell necrosis, and pro-inflammatory cytokine release through several pathways.

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