Trial is testing an oral anti-inflammatory drug that could provide early intervention to regulate immune response to virus

Rutgers has launched a clinical trial to test the safety and efficacy of an oral anti-inflammatory drug that could help prevent serious illness and death in early-stage COVID-19 patients.

The drug, EDP1815, developed by Evelo Biosciences Inc., will be given to newly hospitalized COVID-19 patients at Robert Wood Johnson University Hospital to determine if it can regulate the onslaught of cytokine proteins, which cause the immune system to malfunction and become deadly and is the reason for severe cases of respiratory distress and death.

The trial is led by Reynold Panettieri Jr., vice chancellor for translational medicine and science at Rutgers Biomedical and Health Sciences, and conducted through the Rutgers Institute for Translational Medicine and Science and the New Jersey Alliance for Clinical and Translational Science.

“An earlier clinical trial of the drug in non-COVID-19 patients showed minimal side effects and was effective in reducing the hyperinflammatory response without suppressing the immune system,” Panettieri said. “Our further evaluation in COVID-19 patients will discover how the drug offers benefits to those at risk from developing severe complications related to the virus.”

Many of the most severe cases of acute respiratory distress and death in COVID-19 patients have been linked to an overactive response by cytokines, proteins in the cells that signal a reaction by the immune system. These “cytokine storms” cause the immune system to attack organs, such as the lungs, that they should be protecting.

EDP1815, which has been in development for the treatment of multiple inflammatory diseases, has been shown to be safe and effective for patients with psoriasis. Since it acts on the surface of the gut and does not circulate through the body, patients are not at risk for drug interactions unlike with other existing anti-inflammatories, which cannot be used in combination with other COVID-19 medicines.

The study will evaluate up to 60 newly hospitalized COVID-19 patients at Robert Wood Johnson University Hospital — half receiving EDP1815 and half a placebo — for up to 14 days to see if the treatment reduces the need for oxygen therapy. Patients can enter the trial within 36 hours after arriving in the emergency department with symptoms and testing positive for the virus.

“The readily available testing makes Rutgers an ideal location for successfully conducting early intervention studies,” said Simba Gill, chief executive officer at Evelo Biosciences. “Early intervention may be key to preventing the serious complications that occur as a result of the hyperinflammation caused by the coronavirus. We believe EDP1815’s unique profile could make the drug best suited for early intervention studies.”

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