Roche and Atea partner will jointly develop AT-527 an orally administered direct-acting antiviral (DAA) currently being studied under Phase 2 clinical trials
Roche, Atea to co-develop AT-527 for Covid-19 treatment. (Credit: F. Hoffmann-La Roche Ltd.)
Roche has joined forces with Atea Pharmaceuticals to develop, manufacture and distribute the latter’s investigational oral direct-acting antiviral AT-527, for use against Covid-19.
AT-527 is an investigational, oral, purine nucleotide prodrug, with potential antiviral activity against several enveloped single-stranded RNA viruses, including human flaviviruses and coronaviruses.
The drug was designed to uniquely inhibit viral RNA dependent RNA polymerase, an enzyme that plays crucial role in the replication of RNA viruses.
Currently under Phase 2 clinical studies in hospitalised patients with moderate Covid-19, AT-527 also showed antiviral activity and safety in treating hepatitis C patients, and has potential to become the first oral treatment for non-hospitalised Covid-19 patients, said the company.
Roche Pharmaceuticals chief executive officer Bill Anderson said: “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.
“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, Atea will conduct Phase 3 AT-527 clinical trial in second quarter 2021
The collaboration targets the clinical development and manufacturing of AT-527, to investigate the safety and efficacy of the drug and rapidly provide the potential treatment option to patients.
Under the terms of the agreement, the companies expected to conduct a Phase 3 clinical trial in second quarter 2021 evaluate the potential use in patients outside of the hospital setting.
Once the safety and effectiveness established in clinical trials and regulatory approvals are granted, Atea will distribute the drug in the US, while Roche will manufacture and distribute the drug across territories outside the US.
The company said that the manufacturing process of small-molecule DAAs facilitates the production in large quantities.
Atea Pharmaceuticals founder and chief executive officer Jean-Pierre Sommadossi said: “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.
“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.”