San Diego biotech company CalciMedica has partnered with two Midwestern hospitals to test a drug designed to help COVID-19 patients who are battling severe pneumonia.

The ongoing phase 2 trials — one in St. Paul, Minn., the other in Detroit — are actively recruiting patients, and treatment has already begun for those enrolled. CalciMedica expects to conclude the trials within a couple months. If successful, the anti-inflammatory drug could help COVID-19 patients stay off ventilators and return home from the hospital sooner.

“If our hypothesis is correct, this will have a significant impact in helping health care providers,” said Dr. Sudarshan Hebbar, chief medical officer of the privately held biotech company. “Patients will come to the hospital, they’ll be treated early to keep them off ventilators and out of the ICU, and that will be very beneficial.”

While most people infected with SARS-CoV-2, the virus that causes COVID-19, recover without specialized medical care, a minority develop pneumonia. That happens when the immune response to the virus kicks into overdrive, filling the lungs with dead cells and fluid that make it difficult to breathe.


“These are really bad pneumonias. You see these chest X-rays and you just say, ‘Wow,’” said Dr. Jess Mandel, chief of pulmonary critical care and sleep medicine at UC San Diego.

Ventilators can help patients whose lungs are so weak that they are no longer able to breathe on their own. But these machines are often in short supply, as COVID-19 outbreaks in New York, Italy, and China have illustrated.

And even when patients are put on ventilators, prolonged use can lead to respiratory and heart issues. The heavy sedation that comes with being put on these machines can also make it harder for patients to think and remember clearly after they’ve been taken off a ventilator.

That’s why CalciMedica is testing whether its small molecule drug can prevent COVID-19 patients with severe pneumonia from needing a ventilator. Before the pandemic, the company was already testing whether the drug tamped down inflammation that had spread to the lungs of patients with an inflamed pancreas.


Those studies, conducted at Regions Hospital in St. Paul and Henry Ford Hospital in Detroit, have stopped as the company quickly pivoted to test the drug’s usefulness in COVID-19 patients. With permission from the Food and Drug Administration, CalciMedica is working with these hospitals to recruit at each site 60 patients, 40 of whom will receive the drug and 20 who will be getting the current regimen of oxygen, fluids and close monitoring.

Each patient who gets the experimental treatment will get an intravenous drip of drug spaced out over three days. The physicians treating these patients will keep a close eye on whether they need less oxygen, leave the hospital sooner, and are less likely to go on a ventilator than those in the control group. Physicians at the Regions Hospital treated their first patient on April 10 and have treated less than a dozen patients thus far, according to Dr. Charles Bruen, who is overseeing the trial at Regions.

Within a couple of weeks, physicians should have a preliminary sense of the drug’s safety, though the trial will run for a couple of months, according to Hebbar. The next step would be a much larger trial to test the drug’s effectiveness. If that proves successful, CalciMedica would likely need to rapidly scale up production of its drug, though Hebbar says it is too early for the company to discuss potential partnerships for doing so.

Regardless of the trial results, the drug is not a panacea and would not replace the need for a vaccine or the social distancing measures that have been enacted throughout the country. But Bruen believes it could still help some of the most vulnerable patients breathe a bit easier.


“This is not the medication we’re going to use to either prevent from people from getting COVID-19 or cure them of it,” Bruen said. “This will probably be a part of our armamentarium against COVID-19 for those that end up developing pneumonia and needing hospitalization, but perhaps we can help them.”

