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Cerecor Gets FDA Clearance For Clinical Trial Of CERC-002 In COVID-19 Induced ARDS

Biopharmaceutical company Cerecor Inc. (CERC) said Thursday it has received clearance from the U.S. Food and Drug Administration to proceed with a proof-of-concept clinical trial of its anti-LIGHT monoclonal antibody CERC-002 in patients with COVID-19 cytokine storm induced Acute Respiratory Distress Syndrome or ARDS.

Cerecor noted that the study will assess the efficacy and safety of CERC-002. The first patient is expected to enroll in June and top-line data are expected in the fourth quarter of 2020. The randomized, multi-center, double-blind, placebo-controlled trial will enroll about 82 patients hospitalized with COVID-19 ARDS.

The primary objective of the study is to demonstrate that treatment with CERC-002 results in fewer instances of respiratory failure and death compared to the standard of care. Patients in the CERC-002 arm will receive a single dose of drug and be followed for 28 days.

Key secondary endpoints include ICU length of stay, hospital length of stay and oxygen saturation at the end of study.

Cerecor's chief medical officer, Dr. Jeffrey Wilkins, said, "There is an urgent need for therapies to help patients with COVID-19 ARDS given the ongoing spread of the SARS-CoV-2 and limited therapeutic options. With FDA clearance, we plan to initiate a clinical trial to evaluate anti-LIGHT antibody therapy in patients with COVID-19 cytokine storm-induced ARDS."

According to Cerecor, the scientific rationale for the study was driven by positive results from a recent biomarker study conducted with Hackensack Meridian Health Network demonstrating elevated levels of the inflammatory cytokine LIGHT in patients hospitalized with COVID-19 cytokine storm-induced ARDS.

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