First US COVID-19 Patient Treated with Artificial Antibody in Clinical Trial

Temple University Hospital (Philadelphia, PA, USA) has treated the first patient in the US in the BREATHE clinical trial evaluating the impact of intravenous treatment with gimsilumab on mortality for patients with COVID-19 and acute respiratory distress syndrome (ARDS).

Gimsilumab is a fully human monoclonal antibody targeting granulocyte macrophage-colony stimulating factor (GM-CSF), which is believed to be a key driver of lung hyper-inflammation. Previous evidence from SARS-CoV-1 animal models and emerging data from COVID-19 patients suggests that GM-CSF contributes to the immunopathology caused by SARS-CoV-2 infection in patients with or at risk of developing ARDS. GM-CSF has been found to be up-regulated in the serum of COVID-19 patients according to recent data from patients in China.

Gimsilumab has been tested in numerous non-clinical studies and two prior clinical studies, including a four-week Phase 1 study in healthy volunteers which completed dosing in February. It has demonstrated a favorable safety and tolerability profile based on data collected to date. The multi-site clinical trial will enroll up to 270 patients with a confirmed diagnosis of COVID-19 and clinical evidence of acute lung injury or ARDS. Subjects will be randomized 1:1 to receive either gimsilumab or placebo. The primary endpoint of the study is incidence of mortality by Day 43. Key secondary endpoints include the incidence and duration of mechanical ventilation use during the study, number of days in the intensive care unit, and number of days of inpatient hospitalization.

“Emerging evidence suggests that GM-CSF may contribute to clinical worsening in COVID-19. We are proud to participate in this clinical trial testing gimsilumab in this vulnerable patient population,” said Gerard J. Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University and Director of the Temple Lung Center, who is the principal investigator at Temple University Hospital for the trial.

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