#HGEN announced the first case-control data of lenzilumab in severe COVID-19 demonstrating an 80% reduction in relative risk of invasive mechanical ventilation (IMV) and/or death for patients treated with lenzilumab compared to the matched control group. Lenzilumab, the company’s proprietary Humaneered® anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody drug candidate, is being evaluated in an ongoing Phase III trial and was selected by the National Institutes of Health for its COVID-19 Big Effect Trial. The manuscript, titled “GM-CSF neutralization with lenzilumab in severe COVID-19 patients: A case-control study” was published in Mayo Clinic Proceedings, a premier peer-reviewed journal.
The study involved a total of 39 patients, including 12 treated with lenzilumab, and 27 contemporaneous matched control patients who received standard of care treatment. Lenzilumab treatment was associated with a reduction in risk of progression to IMV and/or death compared to matched controls (8% vs. 41%, p=0.07). Median time to resolution of acute respiratory distress syndrome (ARDS) was one day in the lenzilumab treatment arm versus eight days in the control group (p<0.001). Patients treated with lenzilumab were discharged in a median of five days versus 11 days in the control arm (p=0.008).
Lenzilumab treatment was also associated with a significant reduction in the inflammatory marker c-reactive protein (CRP) relative to the control group (p=0.01) and an improvement in lymphocyte counts relative to the control group (p=0.04). These data suggest that GM-CSF neutralization with lenzilumab may restore balance to the dysregulated immune response induced by SARS-CoV-2 by supressing the myeloid inflammatory response and improving T-cell counts that are thought to be responsible for viral clearance. There were no treatment-emergent adverse events attributable to lenzilumab.
80% reduction in relative risk of invasive mechanical ventilation and/or death in patients treated with lenzilumab compared to the control group
Median time to resolution of acute respiratory distress syndrome (ARDS) reduced to one day for patients treated with lenzilumab versus eight days in control group
Lenzilumab patients discharged from the hospital in less than half the time compared with control group
See HGEN's press release.
See published manuscript.
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