UK-based Izana Bioscience has launched a compassionate use study of namilumab (IZN-101) in patients with rapidly worsening Covid-19 in Bergamo and Milan, Italy.
The two-centre study is being conducted in collaboration with the Humanitas Research group. Eligible patients who are being treated at Humanitas Research Hospitals will be enrolled in the study.
Namilumab is a human monoclonal antibody designed to act on granulocyte macrophage-colony stimulating factor (GM-CSF), involved in various immune-mediated diseases.
Currently, the drug is being developed to treat rheumatoid arthritis and ankylosing spondylitis.
Based on data from studies in China, GM-CSF levels are higher in Covid-19 patients admitted to ICU, indicating potential benefits of early intervention in rapidly worsening individuals.
Izana Bioscience chief executive and co-founder Dr Someit Sidhu said: “The role of GM-CSF in immune-mediated diseases is backed by a strong body of evidence and our growing understanding of Covid-19.
“Evidence suggests that anti-GM-CSF therapy has the potential to change the way patients’ immune systems respond to the virus and therefore to reduce dangerous inflammation and support recovery.”
The compassionate use study will collect data from hospitalised patients and aims to provide treatment before admission to intensive care or need for ventilation.
In addition, the study is intended to help support future development of namilumab in Covid-19 indication. The company is in discussions with regulatory authorities worldwide, including the UK.
Humanitas University internal medicine professor and study coordinator Carlo Selmi said: “Clinicians working on the frontline urgently require new treatment options for their seriously ill Covid-19 patients.
“Anti-GM-CSF therapies such as namilumab could play an important role in how we can prevent or reduce the deterioration in Covid-19 patients for which there are currently few treatments available.”
CRO company Ergomed agreed to support namilumab’s clinical development programme in Covid-19. The company will leverage its expertise, capabilities and clinical site management model.