Most of the drugs being developed for Covid-19 fall into two categories: direct-acting antivirals against the SARS-CoV-2 virus itself and anti-inflammatory medicines meant to address the symptoms of the disease. A newly initiated clinical trial is now combining the two.
Basel, Switzerland-based Roche said Thursday that it had started a Phase III trial combining its anti-inflammatory drug, Actemra (tocilizumab), with Foster City, California-based Gilead Sciences’ antiviral, remdesivir. The trial, which is designed to enroll 450 patients, compares Actemra and remdesivir against remdesivir and placebo.
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The trial, which is expected to start enrolling patients in June, had not yet been posted on ClinicalTrials.gov as of late morning Thursday. However, Roche said results from the study would be expected in the summer.
“Based on our current understanding, we believe that combining an antiviral with an immune modulator could potentially be an effective approach to treating patients with severe disease, Roche chief medical officer Levi Garraway said in a statement. “We’re pleased to partner with Gilead to determine whether combining these medicines could potentially help more patients during this pandemic.”
Data from the much-published Phase III clinical trial conducted by the National Institute of Allergy and Infectious Diseases showed that while the rate of death among patients on remdesivir was numerically lower than that of patients in the placebo arm, the difference was not statistically significant, despite a significant benefit in the time to recovery. Meanwhile, several anti-inflammatory drugs – of which Actemra is but one – are in clinical trials to determine whether they can address the inflammation that is responsible for much of the morbidity and mortality associated with Covid-19.
Other anti-inflammatory medicines that have been tested include Regeneron Pharmaceuticals and Sanofi’s Kevzara (sarilumab), which like Actemra is a monoclonal antibody targeting the inflammatory cytokine IL-6; Incyte and Novartis’ Jakafi (ruxolitinib) and other JAK inhibitors like Eli Lilly’s Olumiant (baricitinib) and Pfizer’s Xeljanz (tofacitinib); and AstraZeneca’s BTK inhibitor Calquence (acalabrutinib).
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