A new clinical trial is testing the safety and efficacy of an oral anti-inflammatory drug that could help prevent serious illness and death from “cytokine storms” in early-stage COVID-19 patients.
Researchers will give the drug, EDP1815, developed by Evelo Biosciences Inc., to newly hospitalized COVID-19 patients at Robert Wood Johnson University Hospital in New Jersey 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.
“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,” says Reynold Panettieri Jr., vice chancellor for translational medicine and science at Rutgers Biomedical and Health Sciences, who is leading the trial. “Our further evaluation in COVID-19 patients will discover how the drug offers benefits 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—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.
Researchers are conducting the clinical trial through the Rutgers Institute for Translational Medicine and Science and the New Jersey Alliance for Clinical and Translational Science.
Source: Rutgers University