Atea Pharmaceuticals Inc. reported positive interim results from the global Phase 2 study evaluating AT-527 in hospitalized patients with mild-to-moderate Covid-19.
Roche Holding AG and Atea are jointly developing AT-527, an oral direct-acting antiviral agent derived from Atea's purine nucleotide prodrug platform.
The biopharmaceutical company said the interim analysis of the Phase 2 study included data from 70 hospitalized, high-risk patients with Covid-19, of which data from 62 patients were evaluable for virology analysis.
Interim virology results indicated that AT-527 rapidly reduced viral load levels. At Day 2, patients receiving AT-527 experienced an 80% greater mean reduction from baseline viral load as compared with placebo. A sustained difference in viral load reduction was maintained through Day 8, the company said.
By Day 14, the last viral sampling study day, 47% of patients in the AT-527 arm and 22% in the placebo arm had no detectable RNA virus. Nasopharyngeal swabs were measured in a reverse transcription polymerase chain reaction test for the quantitative detection of nucleic acid from SARS-CoV-2, the company said.
Consistent with previous studies, AT-527 was generally safe and well tolerated, the company said.
In this study, there were no drug-related serious adverse events. Nonserious adverse events were equally distributed across treatment arms. Most were mild-to-moderate in severity and assessed as not related to the study drug. No safety concerns or newly determined risks were identified, the company said.
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