Roche and Atea Pharmaceuticals, Inc. have partnered to develop, manufacture and distribute AT-527, Atea’s investigational oral direct-acting antiviral, to treat COVID-19. AT-527 acts by blocking the viral RNA polymerase enzyme needed for viral replication, and is currently being studied in a Phase II trial for hospitalized patients with moderate COVID-19. A Phase III trial, expected to start in 1Q21, will explore the potential use in patients outside of the hospital setting. In addition, AT-527 may be developed for post-exposure prophylactic settings.

AT-527, while being a potential oral treatment option for hospitalized patients, also has the potential to be the first oral treatment option for COVID-19 patients that are not hospitalized.  Additionally, the manufacturing process of small-molecule DAAs allows the ability to produce large quantities of the treatment. If successful, AT-527 could help treat patients early, reduce the progression of the infection, and contribute to decreasing the overall burden on health systems.

The collaboration aims to accelerate the clinical development and manufacturing of AT-527, to investigate its safety and efficacy, and to provide this potential treatment option to patients around the world as quickly as possible. If AT-527 proves safe and effective in clinical trials and regulatory approvals are granted, Atea will be responsible for distributing this treatment option in the U.S, with the option to request Genentech’s support, and Roche will be responsible for distribution outside the U.S.