The UK company Izana Bioscience is freely providing its phase III-ready anti-inflammatory antibody namilumab in a compassionate use program for the treatment of patients with coronavirus disease in Italy.
In severe cases of coronavirus disease, also known as Covid-19, patients experience hyperinflammation. One of the drivers of inflammation is thought to be a protein called GM-CSF, which is found at higher levels in Covid-19 intensive care patients, according to recent data from China.
The compassionate use program — where Izana freely provides its drug to two centers in Italy — aims to treat these hospitalized patients before they require ventilation and gather data on their treatment.
“Clinicians working on the frontline urgently require new treatment options for their seriously ill Covid-19 patients,” stated the initiator of the program, Carlo Francesco Selmi, Professor of Internal Medicine at Humanitas University, Milan.
“Therapies such as namilumab could play an important role in how we can prevent or reduce deterioration in Covid-19 patients for which there are currently few treatments available.”
Izana’s antibody therapy is a human monoclonal antibody targeting GM-CSF and is in late-stage clinical development for rheumatoid arthritis and ankylosing spondylitis, allowing the company to move rapidly to phase III.
“We’re lucky with namilumab that it’s a very advanced asset,” Izana’s CEO, Someit Sidhu, told me. “It’s been through over 350 patients. So, we have a very deep database and understanding of both the safety and dose.”
“With Covid-19, it’s the severe patient group who seem to be suffering from a multi-organ failure situation. Because of GM-CSF’s critical role in the cytokine pathways and the inflammatory pathways, we believe that there is a very significant potential for GM-CSF to impact that sort of immuno-modulation that the patients suffering from a hyperinflammatory state may benefit from.”
The company expects that, in addition to providing relief for coronavirus patients, the data gathered will help inform broader clinical programs.
Namilumab is not the only example of clinical-stage antibody therapies being drafted into the treatment of inflammation Covid-19. Kiniksa Pharmaceuticals has deployed its phase II/III antibody, mavrilimumab, which also targets GM-CSF, as part of another Italian Covid-19 program. Roivant Sciences is also seeking regulatory approval to trial its phase II-ready GM-CSF-targeting antibody, gimsilumab, in Covid-19 patients in the United States, Europe, and Asia.
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