Atea Pharmaceuticals Inc (NASDAQ:AVIR) has reported data from the Phase 2 MOONSONG trial of AT-527 in the outpatient setting in patients with mild or moderate COVID-19.
The trial did not meet the primary endpoint of clear reduction in SARS-CoV-2 viral load in the overall population compared to placebo. Approximately two-thirds of patients were low-risk with mild symptoms.
However, in high-risk patients with underlying health conditions, a reduction of viral load of about 0.5 log10 at Day 7 was observed at 550 mg and 1,100 mg BID compared with placebo.
Based on AT-527 data and the evolving COVID-19 environment, Atea and its partner Roche Holdings AG (OTC: RHHBY) are assessing potential modifications to the Phase 3 MORNINGSKY trial.
Hence, the companies now anticipate Phase 3 MORNINGSKY data in the 2H of 2022 against 2H of 2021 expected earlier.
"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.
"Based on these and other AT-527 data, we with our partner Roche, are assessing potential modifications to the Phase 3 MORNINGSKY protocol that may likely lead to improved clinical outcomes," said CEO Jean-Pierre Sommadossi.
"We remain committed to our goal of developing and delivering AT-527 as an oral antiviral that will address treatment needs as COVID-19 continues to evolve."
AVIR shares plunged $28.18, or 69.4% to $12.42 at the open Tuesday.
