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Roche Starts Study on Actemra with Gilead’s Drug for Coronavirus


Roche RHHBY announced that it has initiated a late-stage study on its arthritis drug, Actemra/RoActemra, in combination with Gilead Sciences, Inc. GILD experimental antiviral candidate, remdesivir, in hospitalized patients with severe COVID-19 pneumonia.

The companies have collaborated for a phase III, randomized, double-blind, multicenter study (REMDACTA) to evaluate the safety and efficacy of Actemra/RoActemra combined with remdesivir versus placebo plus remdesivir in these patients.

Per the companies, combining an antiviral with an immune modulator could potentially be an effective approach to treating patients with suffering from this disease.

The study will begin enrolling in June, with a target of approximately 450 patients globally.

Additionally, Roche’s ongoing global randomized, double-blind, placebo-controlled phase III clinical trial (COVACTA, NCT04320615) to evaluate the safety and efficacy of intravenous Actemra/RoActemra plus standard of care (SOC) versus placebo plus SOC in hospitalized adult patients with severe COVID-19 pneumonia is nearing completion of enrollment. The company now targets to enroll 450 patients in the COVACTA study, an increase from the original target of 330 patients. Roche believes that the increase in enrollment will generate robust data while minimally extending the recruitment period. Results from this study are expected later this summer.

The protocol for COVACTA allows the inclusion of patients who are being treated with antivirals, including investigational antivirals. Hence, data from the REMDACTA study are designed to supplement the COVACTA study.

We remind investors that remdesivir has been issued an Emergency Use Authorization by the FDA for the treatment of hospitalized patients with severe COVID-19, given the severity of the pandemic and no end in sight.

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 spread and severity, some approved drugs are being tested to see if they are effective in treating infected patients.

Earlier, Incyte INCY initiated RUXCOVID, a global, randomized, double-blind, placebo-controlled phase III study evaluating the efficacy and safety of Jakafi plus SoC in patients 12 years and above with COVID-19-associated cytokine storm. Alexion ALXN is evaluating its rare disease drug, Ultomiris (ravulizumab-cwvz), for the COVID-19 infection.

Roche’s stock has gained 7.7% in the year so far against the industry’s decline of 1.7%.

Separately, the company also announced updated positive data from the phase III ALEX study on lung cancer drug, Alecensa. The study data showed an increased five-year survival rate with Alecensa (alectinib) compared with Xalkori in patients living with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).

Meanwhile, the European Medicines Agency (EMA) approved a new, two-hour infusion time, dosed twice yearly, multiple sclerosis (MS) drug for the treatment of relapsing or primary progressive multiple sclerosis. The approval is based on a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP).

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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