Experimental drug cuts the risk of hospitalized COVID-19 patients needing a ventilator by 54%, trial data show
- Lenzilumab is a monoclonal antibody that targets a protein known as granulocyte-macrophage colony stimulating factor (GM-CSF)
- GM-CSF is believed to be responsible for cytokine storms occur, which when the body doesn’t just fight off the virus but also attacks its own cells and tissues
- In a group of 520 hospitalized COVID patients, half were given infusions of lenzilumab and other drugs and half were given a placebo and other treatments
- Researchers found 15.6% of patients needed ventilation in the lenzilumab arm compared to 22.1% in the placebo arm, reducing the need by 54%
- Additionally, 9.6% of patients given lenzilumab arm died in comparison with 13.9% who received a placebo
A new drug may help improve the conditions of severely ill coronavirus patients, new trial data suggest.
Lenzilumab, developed by Humanigen Inc, has anti-inflammatory properties that scientists believe can control the immune system’s overreaction to the virus.
When given in combination with other treatments, hospitalized patients were 54 percent more likely to survive without the need for mechanical ventilation.
With only 15.5 percent of the population fully immunized against COVID-19, and hospitalizations on the rise, there a pressing need to test experimental therapies to stop the disease, which has killed more than 549,000 Americans, in its tracks.
Researchers found 15.6% of patients needed ventilation in the lenzilumab arm of the clinical trial compared to 22.1% in the placebo arm, reducing the need by 54%. Additionally, 9.6% of patients given lenzilumab arm died in comparison with 13.9% who received a placebo
Lenzilumab (pictured) is a monoclonal antibody that targets a protein known GM-CSF, which is believed to be responsible for so-called cytokine storms.
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.
Specifically, lenzilumab targets a protein known as granulocyte-macrophage colony stimulating factor (GM-CSF).
GM-CSF is believed to be responsible for the dangerous overreaction to the virus by the body’s immune system called a cytokine storm.
These so-called storms occur when the body doesn’t just fight off the virus but also attacks its own cells and tissues.
In cases of COVID-19, the disease caused by the virus, cytokine storms can trigger respiratory distress, which can lead to multi-system organ failure and death.
By using lenzilumab, patients would have reduced inflammatory cytokine production, and lessen their odds of developing lung injury.
For the Phase III trial, 520 participants aged 18 or older were enrolled across 29 sites in the United States and Brazil.
To be enrolled, the patients needed to be suffering from hypoxia, meaning their blood oxygen saturation levels were 94 percent or less, or were on low-flow oxygen.
Patients were given three infusions of either lenzilumab and other treatments, including steroids and/or remdesivir, or a placebo and those same treatments.
On day 28, researchers found that 15.6 percent of patients needed ventilation in the lenzilumab arm of the trial compared to 22.1 percent in the placebo arm.
This shows patients were 54 percent more likely to survive without the need for invasive ventilation.
What’s more, 9.6 percent of patients in the lenzilumab arm compared with 13.9 percent in the placebo arm
The company says it plans to immediately submit an application for emergency use with the U.S. Food and Drug Administration.
‘The data strongly suggest that lenzilumab improved outcomes for hospitalized patients with COVID-19 pneumonia,’ said principal investigator Dr Zelalem Temesgen, a professor of medicine at the Mayo Clinic, in a statement.
‘The dosing regimen used in this study was specifically designed for hospitalized patients with COVID-19 pneumonia as a potential foundational therapy.
‘Lenzilumab could make the difference between going on a ventilator, which reduces one’s chance of survival, and leaving the hospital alive.’
Humanigen’s lenzilumab is also being tested in a National Institutes of Health-backed study in COVID-19 patients on mechanical ventilation.