As of this morning – Monday April 5 – the current recorded case count for COVID-19 (coronavirus) in the UK has hit 47,806 with 4,934 deaths.
Oxford, UK-based biopharma Izana Bioscience has announced the initiation of a two-centre compassionate use study involving namilumab (IZN-101) in the treatment of patients with rapidly worsening COVID-19 in cooperation with the Humanitas research group.
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.
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, according to recent data from China suggesting that early intervention could be beneficial in patients with rapidly worsening COVID-19, the firm noted.
The compassionate use programme 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.
The study will take place in Italy 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.
He 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.”
Ergomed plc, a CRO specialised in providing bespoke solutions and research services to the pharmaceutical industry, is facilitating this programme.
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