A UK-based bioscience company co-founded by an Indian-origin intrepreneur is testing a rheumatoid arthritis drug to explore its scope in the treatment of patients with rapidly worsening COVID-19 symptoms at hospitals in Italy.
Izana Bioscience said the tests of its antibody therapy namilumab will take place over the coming weeks on COVID-19 patients at Humanitas Research Hospitals in Bergamo and Milan in cooperation with the Humanitas research group.
Izana said that namilumab is the company's 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.
We are very pleased to be supporting this programme with our anti-GM-CSF mAb, namilumab, for the potential treatment of critically-ill Covid-19 patients, said Someit Sidhu the chief executive of Izana Bioscience.
The role of GM-CSF in immunemediated 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, he said.
The so-called compassionate use testing programme, under the leadership of Professor Carlo Selmi head of the Rheumatology and Clinical Immunology Unit at Humanitas Research Hospital and Associate Professor of Internal Medicine at Humanitas University, will gather data from hospitalised, 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.
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Professor Carlo Selmi, coordinator of the study and associate professor of Internal Medicine at Humanitas University, 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.
I am convinced that, even in complicated scenarios such as the current one, it is mandatory to maintain a rigorous scientific approach and in this compassionate use programme we hope to identify patients with a higher inflammatory burden, those we believe are most likely to respond to anti GM-CSF therapy.
Several individual patients are undergoing COVID-19 treatment at Humanitas and eligible ones will be subjected to compassionate use with Namilumab in accordance with local regulations. GM-CSF is a pro-inflammatory cytokine that plays a central role in a broad range of immunemediated diseases.
The cytokine has been found in higher levels of COVID-19 ICU patients, according to recent data from China suggesting that early intervention could be beneficial in patients with rapidly worsening COVID-19.
Izana Bioscience, based in Oxford, describes itself as a translational medicine company focused on bringing innovative science to market. The company has been initially focused on the development of namilumab in rheumatoid arthritis.