Experimental drug reduces risk of hospital COVID-19 patients needing ventilator by 54%, study data shows
- 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, which when the body not only fights the virus, but also attacks its own cells and tissues
- In a group of 520 hospitalized COVID patients, half received infusions of lenzilumab and other drugs and half received placebo and other treatments.
- Researchers found that 15.6% of patients required ventilation in the lenzilumab arm compared to 22.1% in the placebo arm, reducing need by 54%
- In addition, 9.6% of patients who received the lenzilumab arm died, compared to 13.9% who received a placebo
A new drug could help improve the conditions of critically ill coronavirus patients, new research data suggests.
Developed by Humanigen Inc, Lenzilumab has anti-inflammatory properties that scientists believe can control the immune system’s overreaction to the virus.
In combination with other treatments, hospital patients were 54 percent more likely to survive without mechanical ventilation.
With only 15.5 percent of the population fully immunized against COVID-19 and hospital admissions on the rise, there is an urgent need to test experimental therapies to stop the disease, which has killed more than 549,000 Americans in its path.
Researchers found that 15.6% of patients required ventilation in the lenzilumab arm of the clinical trial, compared with 22.1% in the placebo arm, reducing need by 54%. In addition, 9.6% of patients who received the lenzilumab arm died, compared to 13.9% who received a placebo
Lenzilumab (pictured) is a monoclonal antibody that targets a protein known as 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 infections.
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, a so-called cytokine storm.
These so-called storms occur when the body not only fights the virus, but also attacks its own cells and tissues.
In cases of COVID-19, the disease caused by the virus, cytokine storms can cause breathing problems, which can lead to organ failure and death.
By taking lenzilumab, patients are said to reduce the production of inflammatory cytokines and their risk of lung injury.
The Phase III study enrolled 520 participants 18 years of age or older at 29 sites in the United States and Brazil.
To enroll, the patients had to be either hypoxic, meaning their blood oxygen saturation levels were 94 percent or less, or they were using low-flow oxygen.
Patients received three infusions of either lenzilumab and other treatments, including steroids and / or remdesivir, or placebo and the same treatments.
On Day 28, researchers found that 15.6 percent of patients required ventilation in the study’s lenzilumab arm, compared with 22.1 percent in the placebo arm.
This shows that patients were 54 percent more likely to survive without invasive ventilation.
In addition, 9.6 percent of patients in the lenzilumab arm compared to 13.9 percent in the placebo arm
The company says it plans to file an immediate application for emergency use with the U.S. Food and Drug Administration.
“ The data strongly suggests that lenzilumab improved outcomes for hospitalized patients with COVID-19 pneumonia, ” said lead investigator Dr. Zelalem Temesgen, a professor of medicine at the Mayo Clinic, in a statement. statement
The dosing regimen used in this study was specifically designed for hospital patients with COVID-19 pneumonia as a potential base therapy.
“Lenzilumab could make the difference between artificial respiration, which reduces the chances 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.