Business
Atea Pharmaceuticals Provides Clinical and Corporate Update and Reports Third Quarter 2021 Financial Results
Phase 3 MORNINGSKY Protocol Amendment to Include New Primary Endpoint, Refined Patient Population and Increased Dose, with Plan to Accelerate Completion of
About this update from Atea Pharmaceuticals, Inc.
[{"type":"text","content":"Phase 3 MORNINGSKY Protocol Amendment to Include New Primary Endpoint, Refined Patient Population and Increased Dose, with Plan to Accelerate Completion of Enrollment Infectious Virus Data Demonstrate AT-527’s Rapid and Potent Antiviral Activity Against COVID-19 in Phase 2 MOONSONG Overall Patient Population Cohort B and High-Risk Patient Subgroup New In Vitro Results Demonstrate AT-511 (Free Base of AT-527) Potent Activity Against COVID-19 Variants of Concern and/or of Interest, Including Delta Conference Call at 4:30 p.m. ET Today BOSTON, Nov. 11, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today reported financial results for the third quarter ended September 30, 2021 and provided a clinical and corporate update. Key highlights of today’s announcement include a planned amendment to the global Phase 3 MORNINGSKY trial protocol, which will be submitted to health authorities, including in the U.S. The amendment includes a new primary endpoint, a refined patient population for enrollment and an increase in dosage. In addition, Atea announced that exploratory analyses of infectious virus from the Phase 2 MOONSONG trial indicate potent antiviral activity of AT-527 with a rapid reduction in viral load in the overall (low and high-risk) patient population and high-risk patient subgroup with AT-527 1,100 mg BID. “New infectious virus data from a quantitative, highly-sensitive live virus assay further demonstrate AT-527's antiviral response potential. In the overall MOONSONG patient population, including low and high risk COVID-19 patients of whom the majority were seropositive, a rapid and potent viral load reduction was achieved with 1,100 mg twice-daily at Day 3 versus placebo. The antiviral effect was even more pronounced in the high-risk patient subgroup and a dose response was observed. These data support the findings from the Phase 2 trial conducted in hospitalized patients,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. “In addition to the notable infectious virus data from the MOONSONG study, new in vitro data indicate that AT-511 (free base of AT-527) is active against variants of concern and/or of interest, including Delta,” continued Dr. Sommadossi. “These results, combined with the protocol amendmen...