Humanigen Inc (OTCMKTS:HGEN) has said the first case-control data of lenzilumab in severe coronavirus (COVID-19) cases demonstrated an 80% reduction in relative risk of invasive mechanical ventilation (IMV) and/or death for patients treated with the drug compared to a matched control group.
Lenzilumab, an 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.
Humanigen said the manuscript of the study 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.
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“We believe these to be some of the most compelling data published to date of an investigational therapeutic with potential to substantially fight the COVID-19 pandemic and we look forward to validating these data with the results of our ongoing Phase III study,” Dr Dale Chappell, chief scientific officer of Humanigen said in a statement.
“We also appreciate that the stakes are even higher after some other pathways being explored across the industry haven’t met their clinical endpoints and rates of infection are increasing in many areas.”
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.
The company said the lenzilumab treatment was associated with a reduction in risk of progression to IMV and/or death compared to matched controls (8% vs 41%). 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. Patients treated with lenzilumab were discharged in a median of five days versus 11 days in the control arm.
Lenzilumab treatment was also associated with a significant reduction in the inflammatory marker c-reactive protein (CRP) relative to the control group and an improvement in lymphocyte counts relative to the control group.
California-based Humanigen said the 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.
“Based on the pathophysiology of an immune hyper-response or cytokine storm following SARS-CoV-2 infection, these data along with prior studies conducted at Mayo Clinic on GM-CSF depletion point to the potential impact of treating cytokine storm in COVID-19 with lenzilumab,” said Humanigen CEO Dr Cameron Durrant.
“As vaccine development continues to progress and we await compelling data, we must also look toward nearer-term achievable goals, such as bringing effective treatments to hospitalized COVID-19 patients this winter. Having a therapeutic that can reduce the risk of ventilation and death from COVID-19 would have a dramatic impact on the arc of the current pandemic both nationally and globally, and potentially help re-set societal response to the pandemic.”
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