Roche is one of the many pharmaceutical companies throwing its hat in the ring in the race to develop a safe and effective COVID-19 treatment. Its drug rheumatoid arthritis drug Actemra began as a front runner, although the world’s first clinical trial of Actemra reported disappointing results.
Actemra, like other arthritis drugs, is designed to inhibit interleukin-6 (IL-6) proteins associated with dangerous inflammation. Researchers hope that the drug can be used to target the inflammation triggered by the coronavirus as well.
Roche Launched Phase III Clinical Trial in March 2020
On March 19, 2020, the Swiss pharmaceutical company Roche announced its partnership with the FDA to initiate a randomized, double-blind, placebo-controlled Phase III clinical trial of Actemra.
In partnership with the Biomedical Advanced Research and Development Authority (BARDA), Roche’s Phase III trial is designed to “evaluate the safety and efficacy of Actemra plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care.”
Enrollment began in April with a target of about 450 patients globally. Researchers seek to establish data on the following primary and secondary endpoints:
- Clinical status
- Mortality
- Mechanical ventilation cases
- Intensive care unit cases
“We are initiating a clinical trial to study Actemra/RoActemra for the treatment of people hospitalised with COVID-19 pneumonia, so that we can better establish the potential role for Actemra/RoActemra in fighting this disease,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development, at the time.
Early Trial Results Fall Short of Expectations
The Italian Medicines Agency (Aifa) authorized a small study of Actemra in the spring and recently reported its early findings. In the trial, which enrolled 126 patients, Actemra did not reduce severe respiratory symptoms, intensive care visits, or death any better than standard treatments.
However, the trial only included a third of the intended number of volunteers, and it was stopped early after an interim analysis raised doubts as to the medication’s efficacy.
“Although not effective in all patients with COVID-19 pneumonia, it is possible that selected subgroups of patients may have a better response,” Aifa said. Experts will have the opportunity to more closely evaluate this possibility after Aifa sends its detailed data to a scientific journal for publication.
Roche has no plans to allow the small Italian study to derail its Phase III study of Actemra and hopes to uncover results that “will provide robust evidence about the benefit/risk profile,” according to a Roche spokesman.
Sources
- https://www.reuters.com/article/us-health-coronavirus-roche-hldg/roche-rheumatoid-arthritis-drug-fails-to-help-covid-19-patients-in-italian-study-idUSKBN23O3GG
- https://www.fiercepharma.com/pharma/roche-s-actemra-fails-italian-study-early-stage-covid-19-pneumonia
- https://www.roche.com/media/releases/med-cor-2020-03-19.htm