March 29 (Reuters) - Drug developer Humanigen Inc said on Monday its lead drug candidate met the main goal of improved survival without the need for mechanical ventilation in patients hospitalized with COVID-19, in a late-stage trial.
Patients receiving the drug, lenzilumab, in combination with other treatments including steroids and Gilead Inc’s remdesivir, were 54% were more likely to survive without mechanical ventilation versus patients on placebo through day 28, Humanigen said.
The study aimed to determine whether lenzilumab can prevent and treat an immune hyper-response called “cytokine storm” and enable ventilator-free survival.
Cytokine storm is phenomenon wherein the body’s immune system has a dangerous overreaction to virus, and ends up killing not only the offending viruses, but the host’s cells and tissues too.
“Our next step is to submit an application for Emergency Use Authorization (EUA) to the Food and Drug Administration as soon as possible,” Chief Executive Officer Cameron Durrant said in a statement.
The trial had enrolled 520 participants across 29 sites in the United States and Brazil who received three infusions of either lenzilumab or placebo along with other treatments.
Lenzilumab belongs to a class of drugs known as monoclonal antibodies, similar to the ones being developed by Regeneron Pharmaceuticals Inc and Eli Lilly and Co for COVID-19.
Monoclonal antibodies are manufactured copies of proteins produced by the body to fight coronavirus infection.
Humanigen’s Lenzilumab is also being tested in a National Institutes of Health-backed study in COVID-19 patients on mechanical ventilation. (Reporting by Mrinalika Roy in Bengaluru; Editing by Shinjini Ganguli)