FDA News

FDA grants fast-track status to novel acute pancreatitis therapy

The FDA has issued fast-track designation to CM4620, a calcium release-activated calcium channel inhibitor for the treatment of acute pancreatitis, for which there are currently no approved therapies, the manufacturer announced.

CM4620 (CalciMedica) “inhibits the uncontrolled increase in intracellular calcium in pancreatic acinar cells, preventing inappropriate digestive enzyme activation, acinar cell dysfunction and death, or necrosis,” according to a press release. The agent 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.”

In vivo animal models of acute pancreatitis have shown the agent has effects on pancreatic necrosis and markers of systemic inflammation like neutrophil enzyme myeloperoxidase in the lung, and the company is currently finishing phase 1 safety studies. It plans to begin patient studies early next year.

“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,” Michael Dunn, president of CalciMedica, said in the press release. “We believe CM4620 holds great promise for patients suffering from acute pancreatitis, who have no therapeutic options today other than supportive care.”

The FDA issues fast-track designation to agents that treat serious conditions and fill an unmet medical need, providing recipients with additional support from the FDA. The designation also makes the agent eligible for accelerated approval and priority review.

Disclosures: Dunn is employed by CalciMedica.

The FDA has issued fast-track designation to CM4620, a calcium release-activated calcium channel inhibitor for the treatment of acute pancreatitis, for which there are currently no approved therapies, the manufacturer announced.

CM4620 (CalciMedica) “inhibits the uncontrolled increase in intracellular calcium in pancreatic acinar cells, preventing inappropriate digestive enzyme activation, acinar cell dysfunction and death, or necrosis,” according to a press release. The agent 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.”

In vivo animal models of acute pancreatitis have shown the agent has effects on pancreatic necrosis and markers of systemic inflammation like neutrophil enzyme myeloperoxidase in the lung, and the company is currently finishing phase 1 safety studies. It plans to begin patient studies early next year.

“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,” Michael Dunn, president of CalciMedica, said in the press release. “We believe CM4620 holds great promise for patients suffering from acute pancreatitis, who have no therapeutic options today other than supportive care.”

The FDA issues fast-track designation to agents that treat serious conditions and fill an unmet medical need, providing recipients with additional support from the FDA. The designation also makes the agent eligible for accelerated approval and priority review.

Disclosures: Dunn is employed by CalciMedica.