University Hospital Ghent and VIB are assessing a drug called Leukine® to treat patients with respiratory illness associated with COVID-19. Major medical centers in Germany and Italy are considering joining the study. The study will evaluate the effect of Leukine® on lung function and patient outcomes.
Alveolar macrophages, a cell type in the lungs, depend on a growth factor (known as GM-CSF) for differentiation and normal functioning. GM-CSF plays a critical role in the defense against viruses and maintaining proper functioning of the immune system. The growth factor provides resistance to influenza and, in animal studies, GM-CSF reduced mortality due to viral pneumonia. Recent data highlight the importance of understanding the immune status of patients and the activation of the immune system to help clear viruses and reduce the risk of secondary infections.
Leukine® is a yeast-derived version of GM-CSF, developed by Partner Therapeutics. It was initially approved in the United States in 1991 and has been approved for use in five clinical indications. Its safety and tolerability profile are well understood.
“Patients with COVID-19 who progress to acute hypoxic respiratory failure due to COVID-19 have very limited treatment options and a high mortality rate,” said Prof. Bart Lambrecht, Principal Investigator for the trial at University Hospital Ghent and the VIB-UGent Center for Inflammation Research. “We rapidly initiated this study with Leukine® because GM-CSF has profound effects on antiviral immunity, can provide the stimulus to restore immune homeostasis in the lung, and can promote lung repair mechanisms.”
Collaboration against COVID-19
“Partner Therapeutics is committed to investigating Leukine in patients with COVID-19 and we are working with academic and government agencies here in the US and in Europe in this effort,” said Dr. Debasish Roychowdhury, Chief Medical Officer at Partner Therapeutics. “We believe, like many investigators and scientists, that GM-CSF has multiple ways by which it may help these patients, including playing a role in clearing the infection, boosting the immune system and repairing damaged tissues.”
For the treatment of COVID-19 associated acute hypoxic respiratory failure, Leukine® will be used in nebulized form for direct inhalation or through intravenous administration for patients already on a respirator. Nebulized Leukine® has already been studied in phase 2 and phase 3 randomized trials in lung conditions that affect alveolar macrophages. IV administration of Leukine® has been studied extensively in other conditions.