Roche and Atea Pharmaceuticals, Inc. announced today that they are joining forces in the fight against COVID-19 to develop, manufacture and distribute AT-527, Atea’s investigational oral direct-acting antiviral, to people around the globe. AT-527 acts by blocking the viral RNA polymerase enzyme needed for viral replication, and is currently being studied in a Phase 2 clinical trial for hospitalised patients with moderate COVID-19. A Phase 3 clinical trial, expected to start in Q1 2021, 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 holds 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 a much needed 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 United States.
“The ongoing complexities of COVID-19 require multiple lines of defence. By joining forces with Atea, we hope to offer an additional treatment option for hospitalised and non-hospitalised COVID-19 patients, and to ease the burden on hospitals during a global pandemic.” said Bill Anderson, Chief Executive Officer of Roche Pharmaceuticals. “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, Ph.D., Chief Executive Officer and Founder of Atea Pharmaceuticals. “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.”
AT-527 is an investigational, oral, purine nucleotide prodrug, which has demonstrated in vitro and in vivo antiviral activity against several enveloped single-stranded RNA viruses, including human flaviviruses and coronaviruses. This highly selective purine nucleotide prodrug was designed to uniquely inhibit viral RNA dependent RNA polymerase, an enzyme that is essential for the replication of RNA viruses. Antiviral activity and safety of AT-527 has been demonstrated in Phase 2 clinical studies of hepatitis C patients, and in preclinical in-vitro assays with SARS-CoV2 virus. AT-527 is not yet licensed or approved for any indication in the United States or any other country.