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The companies will work to accelerate the clinical development and manufacturing of the treatment, while determining its safety and efficacy.
Roche and Boston, MA-based Atea Pharmaceuticals announced on Oct. 22 that they are collaborating to develop, manufacture, and distribute AT-527, Atea’s investigational oral direct-acting antiviral for the treatment of COVID-19.
Under the terms of the partnership, the companies will work to accelerate the clinical development and manufacturing of the treatment, while determining its safety and efficacy, a Roche press release said. If clinical trials and regulatory approvals are granted, Atea will distribute the treatment in the United States, and Roche will handle distribution outside of the US.
AT-527 is currently involved in a Phase II clinical trial for hospitalized patients with moderate COVID-19, with a Phase III clinical trial for patients outside of the hospital setting slated to begin during the first quarter of 2021.
"The ongoing complexities of COVID-19 require multiple lines of defense. By joining forces with Atea, we hope to offer an additional treatment option for hospitalized and non-hospitalized COVID-19 patients, and to ease the burden on hospitals during a global pandemic," said Bill Anderson, CEO of Roche Pharmaceuticals, in the press release. "In jointly developing and manufacturing AT-527 at scale, we seek to make this treatment option available to as many people around the world as we possibly can."
“Roche shares our passion for delivering innovative new medicines to address great unmet medical needs. The COVID-19 pandemic has highlighted the urgent need for a novel, oral antiviral to treat this highly infectious and often deadly virus,” said Jean-Pierre Sommadossi, PhD, CEO and founder of Atea Pharmaceuticals, in the press release. “AT-527 is expected to be ideally suited to combat COVID-19 as it inhibits viral replication by interfering with viral RNA polymerase, a key component in the replication machinery of RNA viruses. Importantly, the manufacturing process for our small molecule direct-acting antiviral allows us to produce AT-527 quickly and at scale.”