Completed Enrollment in Phase 3 SUNRISE-3 Trial for Bemnifosbuvir COVID-19 Treatment

Atea Pharmaceuticals, Inc, a clinical-stage biopharmaceutical company, has completed enrollment for its global phase 3 SUNRISE-3 trial, marking a significant step in developing bemnifosbuvir. This drug, an oral nucleotide polymerase inhibitor, is under investigation as a potential treatment for COVID-19. The trial has attracted over 2,200 patients for the supportive care monotherapy cohort, with fewer than 80 patients in the combination cohort, reflecting the ongoing search for effective COVID-19 therapies, particularly for high-risk populations.

Jean-Pierre Sommadossi, PhD, Chief Executive Officer, and Founder of Atea Pharmaceuticals, highlights the trial's importance in addressing the ongoing need for effective COVID-19 treatments, especially for high-risk populations, bemnifosbuvir, which is anticipated to provide a new oral antiviral treatment option, addressing the urgent need for therapies that can mitigate severe outcomes of COVID-19 infection. Targeting the SARS-CoV-2 RNA polymerase, the drug boasts a unique mechanism that may offer a high barrier to resistance, demonstrating efficacy across various virus variants, including Omicron subvariants.

The SUNRISE-3 trial is a global, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of bemnifosbuvir, administered alongside standard care. Participants, identified as high-risk outpatients with mild or moderate COVID-19, were randomized to receive either bemnifosbuvir or a placebo for 5 days. The primary endpoint focuses on all-cause hospitalization or death through Day 29 post-treatment in the supportive care monotherapy cohort.

The planned interim analyses for safety and futility were deemed no longer relevant following the rapid completion of enrollment, leading to a decision, in agreement with the Data Safety Monitoring Board (DSMB), to proceed directly to the full analysis of the trial. This adaptation reflects the dynamic nature of clinical research, especially in a pandemic.

Atea Pharmaceuticals aims to report the results of the SUNRISE-3 trial in the second half of 2024. The completion of enrollment ahead of schedule and the fast-track designation granted by the US Food and Drug Administration (FDA) underscore the potential of bemnifosbuvir as a valuable addition to the COVID-19 treatment landscape. The company remains committed to addressing the unmet medical needs of patients with serious viral infections, focused on leveraging its proprietary nucleos(t)ide prodrug platform to develop novel antiviral product candidates.

Reference

Atea Pharmaceuticals Completes Patient Enrollment in Global Phase 3 SUNRISE-3 Trial Evaluating Oral Antiviral Bemnifosbuvir for COVID-19 in High-Risk Patients. Press Release. Published March 27, 2024. Accessed March 28, 2024. https://ir.ateapharma.com/news-releases/news-release-details/atea-pharmaceuticals-completes-patient-enrollment-global-phase-3