Roche’s treatment for coronavirus enters Phase III
The Swiss company announced that it would work with the US Food and Drug Administration (FDA) to begin a Phase III trial into the use of Actemra (tocilizumab) as a treatment for severe COVID-19 pneumonia.
The trial will recruit approximately 330 patients globally, with enrollment anticipated to begin in early April.
Actemra, which is an anti-interleukin-6 (IL-6) receptor biologic, was previously recommended by China’s National Health Commission for use with patients who had developed severe complications due to COVID-19 on March 3.
With the novel coronavirus showing no signs of slowing down its spread in the US and Europe, the Swiss company has moved to establish whether the treatment can aid in severe cases of the infection.
Levi Garraway, Roche’s chief medical officer, said, “In these unprecedented times, today’s announcement is an important example of how industry and regulators can collaborate quickly to address the COVID-19 pandemic, and we will share the results as soon as possible.”
The rapid pace of developments regarding the virus has led both the FDA and European authorities to provide frequent updates on actions to support development or to secure the supply chain.
Roche stated that there are already independent clinical trials evaluating the treatment for the coronavirus, but that there are no ‘well-controlled’ studies and ‘limited evidence’ regarding safety and efficacy.
Patients on the trial will be followed for 60 days after receiving the treatment, with interim analysis taking place during the study to determine if there are early signs of efficacy.
This line of inquiry is also being followed by other developers of IL-6 inhibiting treatments, with Sanofi and Regeneron also noting that they had begun recruitment for a Phase II/III trial evaluating their Kevzara (sarilumab) product in the same indication.
The developers believe that the IL-6 pathway is linked to the overactive inflammatory response in the lungs of patients with severe coronavirus infection.