The FDA greenlit the study of an investigational drug that can inhibit the overproduction of cytokines in patients with COVID-19 at risk of ARDS, thereby reducing the chances they may need intubation and ventilation.

In COVID-19, the body’s immune response can trigger a “cytokine storm” that attacks pulmonary endothelial cells, causing severe pneumonia and hypoxemic respiratory failure, ARDS, and death.

The investigational drug CM4620-IE from CalciMedica Inc is a potent and selective small molecule CRAC channel inhibitor that prevents CRAC channel overactivation. The drug has demonstrated clinical safety and potential efficacy in patients with hypoxemia secondary to systemic inflammatory response syndrome (SIRS) from acute pancreatitis.

CalciMedica Inc received a “Study May Proceed” letter from the FDA on Apr 9.

The open-label Phase 2 clinical study aims to enroll 60 patients with severe COVID-19 pneumonia. Forty patients will be assigned to receive CM4620-IE plus standard of care and 20 assigned to receive standard of care alone. The first patients are being enrolled at Regions Hospital in St. Paul and additional patients are expected to be enrolled within the next week at Henry Ford Hospital in Detroit. Additional study sites are being evaluated.

“There is a dire need for a fast-acting, potent treatment for patients with severe COVID-19 pneumonia,” said Charles A. Bruen, MD, a critical care and emergency physician at Regions Hospital in Saint Paul, Minn. “Recent clinical studies demonstrated safety and potential efficacy of CM4620-IE in critically ill patients with acute pancreatitis. Its rapid onset makes it ideal for acute settings. It has the potential to prevent the development of ARDS in patients with severe COVID-19 pneumonia and reduce the need for ventilators at a time when there is a shortage of ventilators in healthcare facilities across the US.”

CalciMedica’s rapid receipt of notification from the FDA that it could proceed with its study is part of the agency’s initiative to expedite access to investigational drugs for the treatment COVID-19.

Sudarshan Hebbar, MD, chief medical officer of CalciMedica, added, “The FDA’s quick decision to allow CalciMedica to proceed with dosing of COVID-19 patients underscores the potential of CM4620-IE to benefit these patients. Patient safety is key for us as we rapidly evaluate CM4620-IE in patients with severe COVID-19 pneumonia. Due to the fast-acting nature of the drug, it may quickly lessen the cytokine storm associated with COVID-19 and may stabilize the pulmonary endothelial capillary barrier and prevent more serious lung injury.”