Humanigen Inc. (HGEN) Reports Complete Enrollment in Phase 3 Study of Lenzilumab in Hospitalized Patients with COVID-19

January 29, 2021 7:12 AM EST

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Humanigen, Inc. (NASDAQ: HGEN) today announced it has completed enrollment for its pivotal phase 3 study of lenzilumab for COVID-19. The Company expects to announce top-line data in March 2021.

The primary objective of this Phase 3 randomized, double-blind, placebo-controlled clinical trial, which enrolled 520 patients, is to determine whether lenzilumab in addition to current standard of care can alleviate the immune-mediated cytokine release syndrome (CRS) and improve ventilator-free survival in hospitalized and hypoxic patients with COVID-19 pneumonia.

“Completing enrollment in this Phase 3 study is a significant milestone in the clinical development of lenzilumab,” said Cameron Durrant, MD, MBA, chief executive officer of Humanigen. “Therapeutics are an important tool alongside vaccines to tackle the coronavirus. We are grateful to the trial participants, their families, investigators and healthcare professionals for their contributions and partnership in continuing to advance the development of lenzilumab.”

Humanigen's investigational treatment lenzilumab, a proprietary Humaneered® anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody, is designed to prevent and treat cytokine storm, a complication believed to be a cause of the acute respiratory distress syndrome (ARDS) that can result in invasive mechanical ventilation and death in certain COVID-19 patients. Data showed that almost 90 percent of hospitalized patients with COVID-19 are at risk of this immune hyper-response.

More details on Humanigen’s programs in COVID-19 can be found on the company’s website under the COVID-19 tab. Details on this Phase 3 lenzilumab clinical trial can be found at using Identifier NCT04351152.

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