ROCKVILLE, Md.—Cerecor Inc. and Myriad Genetics, Inc. reported today that levels of a novel cytokine called LIGHT have been highly correlated with disease severity and mortality in a COVID-19 acute respiratory distress syndrome (ARDS) biomarker study. The biomarker study was conducted using the serum samples of 47 hospitalized COVID-19 patients and 30 healthy controls from Hackensack Meridian Health Network.

 

LIGHT is a cytokine with inflammatory actions encoded by the TNFSF14 gene; it has been shown to play a key role in the immune response to viral pneumonia. It also plays an important role in regulating immune responses in the lung, gut and skin. The cytokine stimulates T cell and B cell response, and induces the release of other cytokines such as IL1, IL6, IL-8, IL-10, TNF and GM-CSF.

 

“These data are compelling and demonstrate that the inflammatory cytokine LIGHT may play a key role in cytokine storm associated with COVID-19 ARDS that leads to increased morbidity and mortality,” said Dr. David Perlin, Ph.D., chief scientific officer, senior vice president of the Center for Discovery and Innovation, and professor of Medical Sciences at the Hackensack Meridian School of Medicine at Seton Hall University. “Reducing LIGHT levels might be a key to dampening the cytokine storm in these patients, preventing the need for ventilator support and reducing mortality.”

 

LIGHT levels were significantly elevated in the serum of hospitalized patients with COVID-19 versus healthy controls. The highest LIGHT levels were found in patients who required ventilator support, particularly in patients over 60. The data also demonstrated that elevated LIGHT levels were strongly linked with mortality.

 

Approximately 1,500 people in the U.S. died from COVID-19 every day in April. The viral infection triggers a hyperactive immune response leading to cytokine storm and ARDS, which is a leading cause of death in patients who die of COVID-19. Although this hyper-inflammatory process is poorly understood, the data from this study implicate LIGHT as a potential key driver of cytokine storm leading to ARDS and death.

 

“As a company, we recognized the impact of cytokine storm-induced ARDS and the need for treatment options for patients in this area of high unmet need. We remain focused on the CERC-002 clinical program, and rapidly moving it forward for the treatment of cytokine storm-induced ARDS,” noted Dr. Garry Neil, M.D., chief scientific officer of Cerecor.

 

CERC-002 is a fully human monoclonal antibody with neutralizing action against LIGHT, for the treatment of children with pediatric Crohn’s disease. Cerecor holds an open Investigational New Drug application with the U.S. Food and Drug Administration, and CERC-002 is currently being studied in a Phase 1 clinical trial for patients with refractory severe Crohn’s disease. The trial is not recruiting at present, due to the COVID-19 pandemic.

 

Myriad Genetics’ subsidiary Myriad RBM, Inc. has developed an ultra-sensitive assay for the detection of free LIGHT, in collaboration with Cerecor. The assay is reportedly validated for serum or plasma samples, and has sufficient sensitivity to reliably measure LIGHT from normal and disease subjects.