Cerecor Inc. (NASDAQ:CERC) has announced that the FDA has given it a clearance to go on with its proof-of-concept clinical study of the Anti-LIGHT monoclonal antibody CERC-002 in COVID-19 patients with cytokine-induced ARDS.
Cerecor to evaluate efficacy and safety of CERC-002
The randomized, double-blind multicentre, placebo-controlled clinical trial will assess the safety and efficacy of CERC-002. The company expects to enroll its first patient in the trial in June with the target being around 82 hospitalized patients with COVID-19 induced ARDS. Cerecor expects to release top-line data from the study in the fourth quarter of this year.
The clinical study’s objective is to show that CERC-002 treatment can result in fewer incidences of respiratory failure and deaths than standard of care. The company will administer single doses of CERC-002 to patients in the study who will be observed for four weeks. The trial’s main secondary endpoints include hospital length stay, ICU length stay, and oxygen saturation at the end of the trial.
The clinical study’s rationale is based on the positive result from a recent Hackensack Meridian Health Network study that showed elevated inflammatory cytokine LIGHT levels in hospitalized patients with COVID-19 cytokine storm-induced ARDS. According to data, LIGHT could be playing a role in cytokine storm s resulting in ARDS. A study carried by Cerecor and Myriad Genetics Inc. (NASDAQ:MYGN) indicated that levels of cytokine LIGHT are highly associated with mortality and severity of COVID-19 ARDS.
CERC-002 the first anti-LIGHT therapy
CERC is the first-in-class monoclonal antibody targeting inflammatory cytokine LIGHT. So far, it is the only anti-LIGHT therapy currently under development that has the potential to be a treatment alternative for patients in critical need.
Cerecors’s chief scientific officer, Garry Neil, indicated that the company recognizes the effect of cytokine storm-induced ARDS and the need for a treatment alternative for patients. He added that the company is focused on the CERC-002 program to develop a treatment alternative for patients with ARDS resulting from cytokine storm.