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Atea Pharmaceuticals Provides Update and Topline Results for Phase 2 MOONSONG Trial Evaluating AT-527 in the Outpatient Setting
Topline Phase 2 MOONSONG trial results did not meet the primary endpoint in the overall population of patients with mild or moderate COVID-19, who were mostly
About this update from Atea Pharmaceuticals, Inc.
[{"type":"text","content":"Topline Phase 2 MOONSONG trial results did not meet the primary endpoint in the overall population of patients with mild or moderate COVID-19, who were mostly low-risk with mild symptoms In high-risk patients with underlying health conditions, a reduction of viral load of approximately 0.5 log10 at Day 7 was observed at 550 mg (prespecified subgroup analysis) and 1,100 mg BID (exploratory subgroup analysis) compared with placebo Informed by results from MOONSONG, in addition to the positive interim Phase 2 trial results in hospitalized patients and other data, the Phase 3 MORNINGSKY trial protocol is being rapidly assessed for potential modifications AT-527 was generally safe and well-tolerated in all studies to-date and has shown to be non-mutagenic with no effects on fertility and reproduction in non-clinical studies Conference call at 8:30 a.m. ET today BOSTON, Oct. 19, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today reported that the global Phase 2 MOONSONG trial evaluating AT-527 in the outpatient setting did not 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 to placebo in the overall study population, of which 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 approximately 0.5 log10 at Day 7 was observed at 550 mg (prespecified subgroup analysis) and 1,100 mg BID (exploratory subgroup analysis) compared with placebo. Based on the MOONSONG topline and additional recent results for AT-527 as well as the evolving COVID-19 environment, Atea, together with Roche, are assessing potential modifications to the global Phase 3 MORNINGSKY trial including the trial’s primary endpoint and patient population. As a result, we now anticipate 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. Based on these and other AT-527 data, we with our partner Roche, ...