Atea's Covid-19 Trial Misses Objective in Overall Patient Population
October 19 2021 - 8:06AM
Dow Jones News
By Michael Dabaie
Atea Pharmaceuticals Inc. said the Phase 2 Moonsong trial
evaluating AT-527 didn't meet the primary endpoint in the overall
population of patients with mild or moderate Covid-19, who were
mostly low-risk with mild symptoms.
The company said the study didn't meet the primary endpoint of
reduction from baseline in the amount of SARS-CoV-2 virus in
patients with mild or moderate Covid-19 compared with a placebo in
the overall study population. About two thirds of patients were
low-risk with mild symptoms.
However, it said that in high-risk patients with underlying
health conditions, a reduction of viral load of about 0.5 log(10)
at day 7 was observed at 550 mg for the prespecified subgroup
analysis and 1,100 mg BID for the exploratory subgroup analysis
compared with placebo.
Atea and its partner Roche Holding AG are assessing potential
modifications to the global Phase 3 Morningsky trial including the
trial's primary endpoint and patient population.
As a result, the company said it now anticipates Phase 3
Morningsky data in the second half of 2022.
"The primary endpoint was not achieved in the overall study
population in patients with mild or moderate Covid-19, however,
Moonsong topline data suggest that AT-527 has antiviral activity in
high-risk patients with underlying health conditions as we
previously reported in the Phase 2 hospitalized study," Atea Chief
Executive Jean-Pierre Sommadossi said.
Atea and Roche are jointly developing AT-527 as an oral
direct-acting antiviral for the treatment of Covid-19.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
October 19, 2021 07:51 ET (11:51 GMT)
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