Roche Holding AG RHHBY announced that it has entered into a collaboration agreement with Massachusetts-based privately held company Atea Pharmaceuticals, Inc. for jointly manufacturing and distributing AT-527, a potential oral treatment for hospitalized COVID-19 patients.
The investigational oral direct-acting antiviral (DAA) AT-527 is being developed by Atea and currently in phase II study for addressing hospitalized patients with moderate COVID-19 infection. A phase III study to evaluate the potential use of AT-527 in patients outside the hospital setting is expected to begin in the first quarter of 2021.
If approved, AT-527 will be distributed in the United States by Atea while Roche will be responsible for distribution in the ex-U.S. markets.
We note that Roche is evaluating its rheumatoid arthritis (RA) drug Actemra for the treatment of COVID-19 in various studies and a positive outcome will be a great boost, given the severity of the ongoing pandemic. Moreover, the company has a few diagnostics tests for SARS-CoV-2, the virus that causes the novel coronavirus disease.
It launched diagnostic products for COVID-19, namely SARS-CoV-2 rapid antigen test in the EU, cobas SARS-CoV-2 & influenza A/B test for use on the cobas 6800/8800 System, cobas SARS-CoV-2 & influenza A/B test on the cobas Liat System in urgent and emergency care settings and Elecsys AntiSARS-CoV-2 S antibody test for the markets accepting the CE Mark.
Roche also entered into a partnership deal with Regeneron Pharmaceuticals for its new antiviral antibody cocktail to address COVID-19. Initial data showed that the REGNCOV2 antibody cocktail reduced viral levels and improved symptoms in non-hospitalized COVID-19 patients.
Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. The pharma/biotech sector is racing against time to develop treatments and vaccines to cure the contagion.
Eli Lilly LLY recently submitted an initial request to the FDA for granting an Emergency Use Authorization (EUA) to its antibody therapy candidate LYCoV555 as a monotherapy for the treatment of high-risk patients who were recently diagnosed with mild-to-moderate COVID-19.
Of late, Vir Biotechnology VIR and GlaxoSmithKline’s GSK investigational monoclonal antibody VIR-7831 entered the phase III portion for the early treatment of COVID-19 in patients who are at high risk of hospitalization.
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