Early data from a clinical trial in France has demonstrated encouraging profile of Roche unit Genentech’s rheumatoid arthritis drug tocilizumab (Actemra) to treat seriously ill Covid-19 patients.
The study, which was conducted by the Paris university hospital trust (AP-HP), involved 129 hospitalised patients with moderate or severe viral pneumonia.
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Tocilizumab is designed to mitigate the body’s natural immune response. It is thought to act by addressing cytokine storm, a hyper-immune response induced by the viral pneumonia.
During the trial, the drug was able to ‘significantly’ decrease the number of deaths or life support interventions when compared to a control group.
Around 50% of the trial participants received two tocilizumab injections and standard antibiotics therapy, while the control involved only standard treatment.
The study results, which are yet to be published, were said to indicate clear ‘clinical benefit’ with tocilizumab. However, additional research is required to validate the drug’s effectiveness and potential side effects.
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By GlobalDataLast month, Genentech received US Food and Drug Administration (FDA) approval to conduct a Phase III trial of the drug for the treatment of adults with severe Covid-19 pneumonia.
The Phase III trial, to be performed in partnership with the Biomedical Advanced Research and Development Authority (BARDA), will assess a combination of intravenous tocilizumab and standard of care in hospitalised patients.
In the US, Baylor College of Medicine has started assessing the drug in patients suffering from severe Covid-19 pneumonia.
Patients hospitalised at Baylor St. Luke’s Medical Center and Harris Health System’s Ben Taub Hospital are being enrolled for the study, with an aim to recruit around 330 participants by the end of May.
The study will track clinical response to the drug, along with its safety and effectiveness. It will also monitor disease progression, duration of hospitalisation and need for critical care, among other supportive treatments.
In addition to Baylor College of Medicine, the trial is being performed at more than 50 sites across the US, Europe and Canada.
