Atea Pharmaceuticals Presents Favorable Phase 1 Results for AT-527 at 28th Annual Conference on Retroviruses and Opportunistic Infections
High Lung Levels of Active Triphosphate Predicted with Oral AT-527 for COVID-19 Patients
Data Supportive of AT-527 550 mg BID Dosing Regimen
BOSTON, March 06, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today presented results from the Phase 1 study of AT-527 in healthy volunteers at the 28th Annual Conference on Retroviruses and Opportunistic Infections (CROI) in a Science Spotlight presentation. AT-527 is an orally administered, direct-acting antiviral developmental agent derived from Atea’s purine nucleotide prodrug platform and is in Phase 2 clinical development for the treatment of COVID-19. AT-527 targets SARS-CoV-2 ribonucleic acid (RNA) polymerase (nsp12), a highly conserved gene which is responsible for both viral RNA replication and transcription. Given this preferential conserved target site, it is anticipated that the antiviral activity of AT-527 will continue even in the presence of naturally-evolving variants which are now emerging.
“We were delighted to present these encouraging results at CROI. Since the respiratory tract is the initiation site of the SARS-CoV-2 infection, these data demonstrate the potential for AT-527, our oral antiviral, to have meaningful clinical uptake in the lungs. Specifically, the data demonstrating rapid attainment of steady state with a fast build-up of trough levels enables us to predict that there should be exposure of drug in the lung above levels that are needed to inhibit viral replication,” said Jean-Pierre Sommadossi, Ph.D., Chief Executive Officer and Founder of Atea Pharmaceuticals. “In addition, these results show that AT-527 was well tolerated with a favorable safety and pharmacokinetic profile and are supportive of the dosing regimen for the upcoming Phase 3 program.”
In the Phase 1 study, 20 healthy volunteers were randomized 1:1 to receive oral AT-527 550 mg twice daily (BID) or matching placebo for 5 days. The purpose of this study was to assess the safety and pharmacokinetics (PK) of AT-527 in healthy volunteers and to predict human lung exposure of intracellular AT-9010, the active triphosphate (TP) metabolite of AT-527. Safety assessments included adverse events (AEs), vital signs, electrocardiograms (ECGs), and standard safety laboratory tests. Intensive PK sampling, performed after the first and last two doses, provided information on plasma exposures of AT-511, the free base of AT-527, a hemisulfate salt, and its metabolites including AT-273, the guanosine nucleoside metabolite, a measurable surrogate for intracellular AT-9010.