Roche Terminates Development of COVID-19 Oral Antiviral AT-527

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After Pfizer and Merck's recent successes, failed COVID-19 drug developments have been forgotten by industry insiders. Recently, Roche announced it is abandoning its collaboration with Atea Pharmaceuticals on a COVID-19 drug.

More than a year ago, Roche and Atea signed a $350 million collaboration agreement for the oral antiviral drug AT-527. Derived from Atea's nucleoside (acid) prodrug platform, AT-527 is an orally administered direct-acting antiviral currently under investigation for the treatment of non-hospitalized COVID-19 patients to assess its potential in preventing disease progression and long-term COVID-19 complications. AT-527 has a unique mechanism of action as a dual-targeting drug for NdRp and NiRAN, with the potential to create a high genetic barrier through broad-spectrum antiviral coverage against various SARS-CoV-2 variants.

However, a key phase 2 clinical trial conducted in patients with mild to moderate COVID-19 and disclosed in October this year failed to meet its primary endpoint. The data showed that at day 29, the change from baseline in SARS-CoV-2 viral load in the AT-527 treatment group (550mg, BID) was not significantly reduced compared to the placebo group. This prompted both parties to consider relevant adjustments, which might delay the critical study data by approximately one year.

Roche appears to still be collaborating with Atea despite setbacks and delays. However, the company now wishes to withdraw. In an update released this Tuesday, Roche stated, "The company has made the difficult decision to terminate its collaboration with Atea on the AT-527 project in order to focus its efforts on other COVID-19 activities."

Roche mentioned COVID-19 activities, including its internal diagnostic work and the antibody cocktail therapy Ronapreve developed in collaboration with Regeneron. This cocktail therapy received formal approval from the European Commission this week for use in specific COVID-19 patients.

As Roche exits, all rights and licenses previously granted to Roche by Atea will revert to Atea. This strategic collaboration, including the joint development, is expected to officially terminate on February 10, 2022.

Despite Roche's departure, Atea has not abandoned the AT-527 project yet, stating that its phase 3 trial is still ongoing with data expected in the second half of 2022. Janet Hammond, Chief Development Officer of Atea, said: "We remain committed to developing and delivering AT-527 as an oral antiviral treatment that will meet patients' needs as COVID-19 continues to evolve."

However, it may all be too late. Merck/Ridgeback and Pfizer have recently announced strong clinical trial results for their respective COVID-19 oral drugs, molnupiravir and Paxlovid, and many countries are eager to increase the supply of these drugs. Industry analysts predict that sales of the two oral drugs will reach tens of billions of dollars. Atea has little time and few opportunities left.

If these oral drugs, along with other medications from other pharmaceutical companies (such as GlaxoSmithKline/Vir), prove sufficient to prevent COVID-19 deaths and severe illness in the real world, the demand for such therapies may plummet, as we have seen with COVID-19 vaccines.

Source: As Merck and Pfizer predict incoming billions from their COVID drugs, Roche culls pandemic ties with Atea