Roche and Atea partner to develop potential oral treatment for coronavirus patientsChristian Fernsby ▼ | October 22, 2020
Roche and Atea Pharmaceuticals, Inc. are joining forces in the fight against coronavirus to develop, manufacture and distribute AT-527, Atea’s investigational oral direct acting antiviral.
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 hospitalised patients, also holds the potential to be the first oral treatment option for coronavirus patients that are not hospitalised.
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,
If approved, Atea will distribute AT-527 in the United States and Roche will be responsible for global manufacturing and 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."
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. ■