Roche, Atea Fall After Their Covid Pill Disappoints in Trial

(Bloomberg) -- Roche Holding AG and Atea Pharmaceuticals Inc. shares slid after a failed clinical trial pushed back the timeline on the partners’ experimental Covid-19 pill by a year. 

The antiviral drug missed the main goal of a mid-stage trial of patients with mild or moderate Covid, Atea said Tuesday in a statement. A larger study that’s key for regulatory approval may now need to be modified, delaying its results -- originally expected this year -- to the second half of 2022, according to Atea. The biotech’s shares plunged as much as 74% as of 11:05 a.m. in New York, and Roche’s fell 1.7% in Zurich.

The setback means Roche and its partner are falling farther behind Merck & Co. in the race to bring a Covid pill to market -- an increasingly important effort as the virus appears to be around for the long term, with varying rates of vaccination even in countries with ample supplies of shots. A year and a half into the pandemic, there’s still a need for simple treatments that can prevent patients from reaching the hospital.

Merck’s molnupiravir is set for U.S. Food and Drug Administration committee review next month after positive results. 

What Bloomberg Intelligence Says:

The study failure isn’t a surprise to us given, unlike Merck’s molnupiravir trial, it didn’t just enroll patients at high risk of severe disease, but had the tough aim of reducing symptoms across the spectrum. That’s why it would be good to see the drug’s effect on the one-third of patients who had severe disease. 

--Sam Fazeli, BI Senior Pharma Analyst

Merck’s shares rose as much as 2.6%.  

High-risk patients have shown a reduction of viral load after a week of treatment with the medicine, called AT-527, compared with a placebo, Atea said. Modifying the trial may lead to better results, the company said. 

Changes in the course of the pandemic itself also muddied the results, said Janet Hammond, the company’s chief development officer. The study was designed in late 2020, before either variants or vaccines were much of a factor. Some patients in the trial were vaccinated, but not all got the same shots. Some battled more aggressive variants than others. One way to simplify the results might be to exclude the vaccinated from further studies, Hammond said. 

The experimental Covid pill is the most advanced project in Atea’s portfolio. The Boston-based biotech is also working on antivirals for hepatitis C, dengue and respiratory syncytial virus. 

©2021 Bloomberg L.P.