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Roche's Actemra Meets Goal in Phase III Coronavirus Study

Roche RHHBY announced positive results from a late-stage study evaluating arthritis drug, Actemra/RoActemra (tocilizumab), in patients with COVID-19-associated pneumonia.

The phase III study, EMPACTA (Evaluating Minority Patients with Actemra), a randomized, double-blind, placebo-controlled multicenter study, is evaluating the efficacy and safety of Actemra in the treatment of hospitalized COVID-19-associated pneumonia among patients who are often underrepresented in clinical trials.

The study met its primary endpoint as study results showed that patients with COVID-19-associated pneumonia who received Actemra/RoActemra plus standard of care were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care.

In addition, the cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra/RoActemra arm versus 19.3% in the placebo arm. The study did not identify any new safety signals for Actemra/RoActemra.

Roche will share this data with the FDA and other health authorities around the world. However, key secondary endpoints were not met.

Meanwhile, REMDACTA, a two-armed global phase III, randomized, double-blind, multi-center study, is evaluating the efficacy and safety of Actemra/RoActemra plus Gilead Sciences’ GILD remdesivir, versus placebo plus remdesivir in hospitalized patients with severe COVID-19-associated pneumonia who are already receiving standard of care.

However, the COVACTA study investigating Actemra/RoActemra did not meet its primary endpoint of improved clinical status in patients with COVID-19-associated pneumonia or the key secondary endpoint of reduced patient mortality. Roche is also evaluating this drug in the phase II MARIPOSA study.

Last month, Roche announced a partnership with Regeneron REGN to develop, manufacture and distribute REGN-COV2, Regeneron’s investigational antiviral antibody combination, to people around the globe.

Roche’s stock has gained 14% in the year so far compared with the industry’s growth of 1.3%.

 

Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. The pharma/biotech sector is running a race against time to come up with treatments and vaccines to cure the contagion. Given the alarming levels of the spread and severity of the pandemic, quite a few biotechs are developing antibodies or evaluating their approved drugs or pipeline candidates to determine if they are effective enough to treat the infected patients.

Another pharma giant, Eli Lilly and Company LLY and partner Incyte announced that rheumatoid arthritis drug, Olumiant, in combination with remdesivir met the primary endpoint of reduction of time to recovery in comparison with remdesivir alone.

Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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