New Delhi: A team of international researchers has identified a drug that may be used to treat some patients hospitalized with Covid-19 pneumonia, according to a study published in The Lancet Respiratory Medicine journal. The trial was led by the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust.
The trial, called CATALYST, tested UK-based biopharmaceutical company Izana Biosciences’s namilumab (IZN-101) as a potential therapeutic to treat patients hospitalized with Covid-19 pneumonia.
The patients were receiving ‘usual’ care and had high levels in their blood of a marker of inflammation known as C reactive protein (CRP).
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Inflammation causes CRP levels in the blood to rise. Also, elevated levels of CRP can serve as a potential early marker to predict the severity of Covid-19.
Namilumab is an antibody already in late-stage trials to treat rheumatoid arthritis. It targets a ‘cytokine’ that is naturally secreted by immune cells in the body. However, uncontrolled secretion of cytokine is believed to be a key driver of the excessive and dangerous lung inflammation seen in Covid-19 patients.
The trial was conducted between June 2020 and February 2021 in patients aged more than 16 and suffering from Covid-19 pneumonia. The patients were either being treated in a ward or in Intensive Care Units (ICU) at nine NHS hospitals across the UK.
Of the participants involved in the study, 54 patients were receiving usual care, which means they received steroids and oxygen or ventilation, depending on the severity of the disease. The remaining 57 patients were being given usual care as well as a single intravenous dose of 150 milligrams of namilumab, the study said.
Probability Of Reduction In CRP Was 97% In Namilumab Group
The study participants had CRP levels greater than 40 milligrams per liter. There was a 97 per cent probability of CRP being reduced over time in the patients given namilumab compared with those who received just usual care, the study found.
After being monitored for 28 days, it was found that there were fewer deaths and more discharges from the hospital or ICU in the batch who had received namilumab compared to those receiving usual care alone.
As many as 43 patients receiving namilumab were discharged from the hospital or ICU by Day 28. This accounted for 78 per cent of the patients. On the other hand, only 33 patients who were given usual care were discharged by the same time, accounting for 61 per cent of all participants, the study said.
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By Day 28, six patients in the namilumab group were still in the hospital, compared to 11 patients in the usual care group. In the namilumab group, 6 patients died, while in the usual care group, 10 patients died.
The differences between the two groups in overall probability of those being discharged from ICU or a ward at 28 days was calculated. In the usual care group, the probability of being discharged from a ward was 64 per cent at Day 28. In the namilumab cohort, it was 77 per cent.
For patients in the ICU, the probability of discharge at Day 28 was 47 per cent in the usual care group, while it was 66 per cent in the Namilumab cohort.
Dr. Ben Fisher, co-chief investigator of the CATALYST trial at the University of Birmingham’s Institute of Inflammation and Aging, said that the research provided important proof-of-concept evidence that namilumab reduces inflammation in hospitalized patients with Covid-19 pneumonia, according to a statement issued by the University of Birmingham.
He said the sample size was too small for a definitive assessment of clinical outcomes and further studies were required for this. He said the results might not generalize to hospitalised patients without evidence of pneumonia or raised CRP patients not requiring hospitalisation.
Therefore, it is important that namilumab is now prioritized for further Covid-19 research in a much larger national Phase III clinical trial, he explained.
Namilumab Can Dampen Hyper-Inflammation In Patients With Severe Covid-19
Dr Someit Sidhu, co-founder of Izana Bioscience, said the company was proud to support the CATALYST trial led by the highly experienced team at the University of Birmingham and UHB.
“We believe namilumab can play a significant role in dampening the hyper-inflammation seen in patients with severe Covid-19 infection and are committed to working with regulators and partners across the world to ensure this potential therapy can be developed for patients with Covid-19 who urgently need treatments,” the statement quoted him as saying.
Infliximab Drug Was Also Tested
A second drug called infliximab (CT-P13) was also tested by the CATALYST team. The same patients with Covid-19 pneumonia and CRP levels greater than 40 milligrams per liter receiving usual care and a single intravenous dose of five milligrams per kilogram of infliximab were compared. The study, however, found infliximab was not more effective than usual care, with just a 15 per cent probability of CRP being reduced.
Dr Fisher added that the findings relating to infliximab were important as the researchers continue to investigate and identify existing and new anti-inflammatory drugs that might play a critical role in targeting and reducing the most serious symptoms of Covid-19.
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