Roche said Thursday that it has initiated a Phase III study in collaboration with Gilead Sciences to investigate the efficacy of the anti-IL-6 receptor biologic Actemra/RoActemra (tocilizumab) in combination with remdesivir in hospitalised patients with severe COVID-19 pneumonia. The REMDACTA trial will compare the combination to placebo plus remdesivir in patients receiving standard of care.
The study is expected to begin enrolling patients in June with a target of approximately 450 subjects globally. The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care variables, with patients followed for 60 days post-randomisation.
Antiviral plus immune modulator
"As more information about COVID-19 pneumonia becomes available in these unprecedented times, it is more important than ever to work together to fight this disease," remarked Levi Garraway, Roche's head of global product development. Garraway explained "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."
Commenting on the news, Bloomberg Intelligence analyst Sam Fazeli noted that inflammation-dampening drugs are not without risk, since they limit the body's ability to fight the infection. "This makes it crucial to decipher the best timing of treatment," he said.
Earlier this month, the US National Institute of Allergy and Infectious Diseases (NIAID) started enrolling hospitalised adults with COVID-19 in the US to take part in the ACTT 2 study evaluating the combination of remdesivir with Eli Lilly and Incyte's JAK inhibitor Olumiant (baricitinib) as a potential treatment. At the time, the NIAID noted that some patients with COVID-19 experience acute respiratory distress syndrome, and that the potential benefit of Olumiant, which inhibits cytokine signaling, had "been described in a case series of critically ill patients who recovered from COVID-19."
Roche is also completing enrolment in the Phase III COVACTA trial, which is evaluating Actemra/RoActemra plus standard of care, versus placebo plus standard of care, in hospitalised adults with severe COVID-19 pneumonia. The company said Thursday that the original enrolment target of 330 patients has been increased to 450 to "allow for even more robust data." The drugmaker indicated that the study's protocol allows the inclusion of patients who are being treated with antivirals, including investigational drugs.
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