11 March 2021 - - The global Phase III randomized, double-blind, multicenter REMDACTA study of Actemra (tocilizumab) plus Veklury (remdesivir), versus placebo plus Veklury, did not meet its primary endpoint, US-based biotechnology company Genentech said.

Genentech is a member of Switzerland's Roche Group (SIX: RO) (OTCQX: RHHBY).

This was measured by improved time to hospital discharge up to day 28 in patients with severe COVID-19 pneumonia receiving standard of care.

No new safety signals were identified for Actemra in the REMDACTA trial. The study was conducted in collaboration with Gilead Sciences, Inc.

Genentech will continue to evaluate data from the REMDACTA, COVACTA and EMPACTA studies as well as other studies of Actemra in COVID-19 pneumonia.

The EMPACTA study met its primary endpoint, while COVACTA did not meet its primary endpoint. Both were recently published in the New England Journal of Medicine.

REMDACTA did not meet key secondary endpoints, which included likelihood of death, likelihood of progression to mechanical ventilation or death, and clinical status.

The full results of the trial will be submitted for publication in a peer-reviewed journal later this year.

Actemra is not approved for the treatment of COVID-19 pneumonia.

The antiviral medication Veklury was invented and developed by Gilead Sciences and is approved by the US Food and Drug Administration for the treatment of adults and pediatric patients at least 12 years of age and weighing at least 40 kilograms requiring hospitalization for COVID-19.

Veklury is contraindicated in patients who are allergic to Veklury or any of its components.

REMDACTA is a two-armed global Phase III, randomized, double-blind, multicenter study (REMDACTA, NCT04409262) to evaluate the efficacy and safety of Actemra plus Veklury, versus placebo plus Veklury in hospitalized patients with severe COVID-19 pneumonia receiving standard of care.

Veklury is an antiviral medicine that works to stop replication of SARS-CoV-2, the virus that causes COVID-19.

The REMDACTA trial is being conducted in collaboration with Gilead Sciences, Inc. The primary endpoint of the study is improvement in time to hospital discharge by day 28.

Key secondary endpoints include likelihood of death, likelihood of progression to mechanical ventilation or death, and clinical status.

Clinical status is measured by the 7-category ordinal scale, which tracks patients' clinical status based on the need for intensive care and/or ventilator use, as well as supplemental oxygen requirements. Patients will be followed for 60 days post-randomization.

COVACTA is a global, randomized, double-blind, placebo-controlled Phase III study (COVACTA, NCT04320615) which evaluated the safety and efficacy of intravenous Actemra added to standard of care in adult patients hospitalized with severe COVID-19 pneumonia compared to placebo plus standard of care.

The primary and secondary endpoints included clinical status, mortality, mechanical ventilation and intensive care unit variables. Patients were followed for 60 days post-randomization.

EMPACTA (Evaluating Minority Patients with Actemra) is a Phase III, randomized, double-blind, placebo-controlled multicenter study (EMPACTA, NCT04372186) which evaluated the efficacy and safety of Actemra in the treatment of hospitalized COVID-19 pneumonia among patients that are often underrepresented in clinical trials.

The primary endpoint was the cumulative proportion of participants dying or requiring mechanical ventilation by day 28. Secondary endpoints included: time to clinical failure, defined as the time to death, mechanical ventilation, ICU admission, or withdrawal (whichever occurs first); mortality rate by day 28; and time to hospital discharge or "ready for discharge."

Actemra was the first humanized interleukin-6 receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate, that did not provide enough relief.

The extensive Actemra RA IV clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries.

The Actemra RA subcutaneous clinical development program included two Phase III clinical studies and enrolled more than 1,800 people with RA in 33 countries.

Actemra subcutaneous injection is also approved for the treatment of adult patients with giant cell arteritis, for the treatment of patients two years of age and older with active polyarticular juvenile idiopathic arthritis or active systemic juvenile idiopathic arthritis, and for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).