Roche to pay Atea $350M for ex-U.S. rights to COVID-19 antiviral

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Roche to pay Atea $350M for ex-U.S. rights to COVID-19 antiviral

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Roche to pay Atea $350M for ex-U.S. rights to COVID-19 antiviral

https://www.fiercebiotech.com/biotech/r ... -antiviral

Roche is paying Atea Pharmaceuticals $350 million upfront for the ex-U.S. rights to COVID-19 antiviral AT-527. The oral direct-acting antiviral is set to enter a phase 3 trial in non-hospitalized patients early next year, giving Roche and Atea a shot at establishing it as the go-to early treatment for COVID-19.

Atea put its COVID-19 program on the map in May when it raised $215 million in a round led by Bain Capital Life Sciences. Up to that point, Atea was perhaps best known for being set up by Jean-Pierre Sommadossi, co-founder of Sovaldi developer Pharmasset.

Reflecting Sommadossi’s background, Atea initially studied its oral purine nucleotide prodrug AT-527 in hepatitis C, before the pandemic and in vitro evidence of efficacy in coronaviruses persuaded it to target SARS-CoV-2. A phase 2 trial of 190 hospitalized patients with moderate COVID-19 got started in May and is due to wrap up around the end of the year, according to ClinicalTrials.gov.

“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,” Sommadossi said in a statement.

The phase 2 results will provide a clearer picture of whether AT-527 is efficacious in COVID-19, but Roche has already seen enough to bet $350 million and commit to milestones and royalties. The outlay secures Roche ex-U.S. rights to AT-527. Atea will retain responsibility for distributing the drug in the U.S., although it has an option to ask for the support of Roche’s Genentech.

While AT-527 is currently in development in hospitalized patients, Roche centered its discussion of the value of the drug on its potential role in non-hospitalized patients. As an oral small molecule, AT-527 has several potential advantages over anti-SARS-CoV-2 antibodies outside of hospital settings. AT-527 stands to be cheaper, easier to administer and manufactured at larger quantities.

Atea and Roche plan to start a phase 3 trial in non-hospitalized patients in the first quarter of 2021. By then, the U.S. and other countries may have begun vaccinating their populations against the novel coronavirus, thereby beginning the process of bringing the pandemic under control. However, with the rollout of immunization programs taking time and vaccines likely to only offer partial protection, Atea and Roche are betting there will remain a need for treatments for some time.

Roche foresees AT-527 being used to treat patients early, perhaps even in post-exposure prophylactic settings. Widespread access to an effective early treatment could stop some cases from progressing to severe COVID-19, thereby improving patient outcomes and reducing the burden on healthcare systems.

The deal opens up another front in Roche’s response to the pandemic. In August, Roche secured the ex-U.S. rights to Regeneron’s REGN-COV2, securing itself a leading spot in the race to bring COVID-19 antibody therapies to market. The deals position Roche to apply its development and manufacturing muscle to drugs with the potential to defang SARS-CoV-2.
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