Benzinga | Jul 21, 2020 07:06AM EDT

Cerecor Announces First Patient Enrolled In Multicenter Proof-Of-Concept Study Evaluating CERC-002 For COVID-19 ARDS

ROCKVILLE, Md., July 21, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare pediatric and orphan diseases, today announced the first patient has been enrolled in a proof-of-concept trial evaluating the safety and efficacy of the anti-LIGHT monoclonal antibody, CERC-002, in patients with COVID-19 cytokine storm-induced Acute Respiratory Distress Syndrome (ARDS).

The proof-of-concept, randomized, multicenter, double-blind, placebo-controlled trial will enroll approximately 82 subjects 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 versus 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 intensive care unit (ICU) length of stay, hospital length of stay, and oxygen saturation at the end of the study. Top-line data are expected in the fourth quarter of 2020.

"We believe that suppressing levels of the inflammatory cytokine LIGHT, which is associated with increased morbidity and mortality in ventilated COVID-19 patients, might dampen the cytokine storm and prevent severe ARDS in this population," said H. Jeffrey Wilkins, MD, Chief Medical Officer of Cerecor. "As the first and only fully human anti-LIGHT monoclonal antibody, we believe CERC-002 has the potential to treat patients hospitalized with COVID-19 ARDS. Our collaboration with PRA Health Sciences -- a contract research organization and healthcare intelligence partner -- has helped us to rapidly identify, recruit and initiate key centers to expedite the study. Both organizations look forward to advancing this program, as we strive to provide an effective therapeutic option for hospitalized COVID-19 patients to keep them from progressing to ARDS."

The scientific rationale for the study is supported by positive results from Cerecor's and Myriad Genetics' recent biomarker study, conducted with Hackensack Meridian Health Network, which demonstrated elevated levels of the inflammatory cytokine LIGHT in patients hospitalized with COVID-19 cytokine storm-induced ARDS. In the patients studied, LIGHT levels were significantly elevated in the serum of hospitalized patients with COVID-19 versus healthy controls (p value < 0.0001). The highest LIGHT levels were found in patients who required ventilator support, particularly in patients over 60 years of age. Importantly, the data demonstrated elevated LIGHT levels were also strongly linked with mortality (p=0.02). The data suggest that LIGHT might play a key role in cytokine storm that leads to ARDS. CERC-002 is a first-in-class monoclonal antibody targeted against the inflammatory cytokine LIGHT. It is the only anti-LIGHT therapy in clinical development and has the potential to be a treatment option for this patient population in critical need.