CalciMedica moves inflammation-targeting COVID-19 drug into phase 2

Concept of SARS-CoV-2 or COVID-19
The phase 2 study of the drug aims to enroll 60 patients with severe pneumonia caused by COVID-19. (COVID-19 coronavirus Maksim Tkachenko / iStock / Getty Images Plus)

As the number of COVID-19 cases rises, so does the demand for critical medical supplies, leading governments and companies to ramp up the production of new ventilators and the FDA to authorize the use of other devices, such as CPAP machines, to fill the gap. Others, like CalciMedica, are looking for a drug solution to intervene before a patient will need a ventilator.

The FDA green-lighted a clinical trial for the company’s CRAC channel inhibitor in patients with severe pneumonia caused by the new coronavirus, SARS-CoV-2. The drug, CM4620-IE, is designed to settle down an overactive immune system to reduce inflammation, CalciMedica Chief Medical Officer Sudarshan Hebbar, M.D., told FierceBiotech.

“The CRAC channel is a proximal step in cytokine production by T cells. We downregulate IL-6, IL-17, tumor necrosis factor alpha and other bad actors. In addition, we minimize neutrophil burst and neutrophil migration,” he said.

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The drug is designed to ward off cytokine storm, which happens when the immune system is activated too strongly and damages the body’s own cells, as well as protect the barrier between the lungs and their blood supply, preventing the breakdown of capillaries and fluid filling the lung’s air sacs. It is given intravenously, so it works quickly, Hebbar said, which is important in patients whose condition can deteriorate quickly, necessitating mechanical ventilation.

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The phase 2 study of the drug aims to enroll 60 patients with severe pneumonia caused by COVID-19. One-third of them will receive standard of care, while the remaining two-thirds will receive CalciMedica’s drug alongside standard of care.

 “There is a dire need for a fast-acting, potent treatment for patients with severe COVID-19 pneumonia,” said Charles Bruen, M.D., a critical care and emergency physician at Regions Hospital in St. Paul, Minnesota, which started enrolling patients for the study on Thursday.

“It has the potential to prevent the development of ARDS [acute respiratory distress syndrome] 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 U.S,” Bruen added, referring to a life-threatening type of lung failure caused by inflammation. Even patients who recover from ARDS may have permanent damage to their lungs.

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