Izana Bioscience has initiated a compassionate use study involving namilumab (IZN-101) in the treatment of patients with rapidly worsening COVID-19 in cooperation with the Humanitas research group. The study will take place in Bergamo and Milan, Italy.
 
Namilumab is the company’s wholly-owned, phase III-ready, fully human monoclonal antibody therapy targeting granulocyte-macrophage colony stimulating factor (GM-CSF), currently in late-stage clinical development for the treatment of rheumatoid arthritis and ankylosing spondylitis.
 
GM-CSF is a pro-inflammatory cytokine that plays a central role in a broad range of immune-mediated diseases. The cytokine has been found in higher levels of COVID-19 ICU patients suggests that early intervention could be beneficial in patients with rapidly worsening COVID-19.
 
The compassionate use program will gather data from hospitalized, rapidly worsening COVID-19 patients, and has the overall objective of treating them before they are admitted to intensive care or require ventilation.

It also aims to support namilumab’s future development for the treatment of COVID-19, and discussions with global regulatory authorities, including the UK, are in progress.