Roche/Gilead tag team fights COVID-19 with Actemra/remdesivir

The 450-patient phase 3 trial combines an antiviral with an immune modulator

Roche and Gilead Sciences are joining forcers to fight COVID-19 with a 450-patient trial that will combine two drugs already being tested against coronavirus as monotherapies.

The 450-patient phase 3 trial is pairing Gilead’s polymerase inhibitor remdesivir – designed to inhibit replication of the virus – with Roche’s IL-6 inhibitor Actemra/RoActemra (tocilizumab) which acts as an anti-inflammatory drug.

The hope is the two drugs will provide a double whammy in COVID-19 patients, attacking the virus directly and also curbing the runaway immune response – known as the ‘cytokine storm’ – that in some patients leads to pneumonia and acute respiratory distress syndrome (ARDS) and can also damage other organs.

The study – called REMDACTA – will start enrolling hospitalised COVID-19 patients next month, according to Roche.

“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,” said Levi Garraway, Roche’s chief medical officer.

“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,” he added.

The US and Japan have also approved emergency use of remdesivir, while the European Commission has issued recommendations for compassionate use and started a rolling review of its use in coronavirus patients.

The drug has been shown to cut the recovery time for people hospitalised with severe coronavirus symptoms, although it doesn’t seem to be as effective in those who are the worst affected and require mechanical ventilation.

There seems to be little doubt that multiple drugs will be needed to manage severe COVID-19 cases, which along with attacking the lungs also affects other organs and can lead to septic shock and catastrophic reductions in blood pressure.

Roche meanwhile says it is close to completing the target enrolment of 450 subjects in its phase 3 trial of Actemra in severe COVID-19, and results should be available in the summer.

Sales of the drug rocketed in the first quarter of the year as orders flooded in from around the world in the early stages of the pandemic.

It was first approved to treat rheumatoid arthritis, but has emerged as an important treatment for cytokine storm – also known as cytokine release syndrome (CRS) – that occurs in patients treated with CAR-T cell therapies for cancer.