AVIR - Atea Announces Presentation of Data Highlighting Favorable Safety Profile of Bemnifosbuvir at ESCMID Global 2024 | Benzinga
BOSTON, April 29, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) (Atea), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced the presentation of Phase 1 data highlighting the safety profile of bemnifosbuvir, an oral nucleotide polymerase inhibitor, at the European Society of Clinical Microbiology & Infectious Diseases Global 2024 (ESCMID, formerly ECCMID), which is taking place April 27-30, 2024 in Barcelona, Spain.
"The results presented at ESCMID further support the favorable safety profile for bemnifosbuvir by demonstrating the lack of cardiotoxicity in healthy participants," said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. "Our goal is to address the substantial unmet need for the treatment of COVID-19 and hepatitis C virus (HCV), which continues due to the limitations of available treatments. During the second half of 2024, we look forward to reporting results for bemnifosbuvir from our Phase 3 SUNRISE-3 trial for COVID-19 and results for the combination of bemnifosbuvir and ruzasvir from our Phase 2 trial for HCV."
Details for the poster presentation are as follows:
Poster Number: P0419
Abstract Number: 2927
Date and Time: April 27, 2024, 12:00 PM CET
Title: A Phase 1, Concentration-QTc Analysis Shows Bemnifosbuvir Does Not Alter Cardiac Repolarization
In this study, eligible healthy participants 18–65 years of age (n=42) were enrolled into multiple ascending dose cohorts and randomized to receive 550 mg, 825 mg or 1100 mg twice-daily oral bemnifosbuvir or matching placebo.
Results showed that the studied doses did not have any clinically relevant effect on cardiac repolarization, heart rate, PR interval (time between atrial depolarization and ventricular depolarization), or QRS (ventricular depolarization) duration. The results also demonstrated that a QTc effect (the duration of the QT interval adjusted for the participant's heart rate) greater than 10 milliseconds (established threshold of regulatory concern) is unlikely across the full observed plasma concentration ranges of bemnifosbuvir and its metabolites.
These clinical data confirm the preclinical in vitro and in vivo study results, suggesting bemnifosbuvir has a low potential for cardiotoxicity with no predicted arrhythmic QTc-interval prolongation or inhibition of the human mitochondrial DNA-directed RNA polymerase.
About Bemnifosbuvir for COVID-19
The global Phase 3 SUNRISE-3 trial is evaluating bemnifosbuvir, an oral nucleotide polymerase inhibitor, or placebo for the treatment of COVID-19. SUNRISE-3 is a randomized, double-blind, placebo-controlled trial.
In March 2024, Atea completed enrollment of SUNRISE-3 with over 2,200 high-risk patients in the ...