Actemra/RoActemra is an anti-IL-6 receptor biologic approved for the treatment of moderate-to-severe active rheumatoid arthritis (RA) in adult patients
Roche initiates phase 3 REMDACTA clinical trial to evaluate Covid-19 treatment. (Credit: F. Hoffmann-La Roche Ltd.)
Roche, in collaboration with Gilead Sciences, has initiated a phase 3 clinical study of Actemra/RoActemra plus investigational antiviral remdesivir, dubbed REMDACTA, in hospitalised patients with severe Covid-19 pneumonia.
Actemra/RoActemra is an anti-IL-6 receptor biologic approved for the treatment of moderate-to-severe active rheumatoid arthritis (RA) in adult patients. The drug is available in both intravenous (IV) and subcutaneous (SC) formulations.
The drug can be used alone or with methotrexate (MTX) in adult RA patients who are intolerant to, or have failed to respond to, other disease-modifying anti-rheumatic drugs (DMARDs)
The US Food & Drug Administration (FDA) has granted Emergency Use Authorisation (EUA) for remdesivir to treat hospitalised patients with severe Covid-19. Remdesivir is an investigational antiviral drug, currently being studied in multiple ongoing international clinical trials.
Roche chief medical officer and global product development head Levi Garraway said: “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.
“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. We’re pleased to partner with Gilead to determine whether combining these medicines could potentially help more patients during this pandemic.”
REMDACTA study will enrol around 450 Covid-19 patients with severe pneumonia
REMDACTA is a two-armed global phase 3, randomised, double-blind, multicentre study, designed to evaluate the safety and efficacy of Actemra/RoActemra plus remdesivir, compared to placebo plus remdesivir in Covid-19 patients with severe pneumonia.
The primary and secondary endpoints of the clinical trial include clinical status, mortality, mechanical ventilation, and intensive care variables, and the patients will be followed for 60 days after randomisation.
The clinical trial is expected to initiate enrolment of participants, targeting approximately 450 patients around the world, in June 2020.