Atea Shares Positive HCV Phase 2 Results and COVID-19 Trial Enrollment Milestone

A clinical-stage biopharmaceutical company, Atea Pharmaceuticals, has made significant strides in its development of oral antiviral treatments for Hepatitis C Virus (HCV) and COVID-19. The company has reported promising results from the initial 52 patients in its Phase 2 study, which combines bemnifosbuvir and ruzasvir (RZR) for HCV treatment. These patients exhibited a 98% Sustained Virologic Response at Week 4 (SVR4) post-treatment, surpassing the efficacy benchmark of over 90%.
Atea's Phase 3 SUNRISE-3 trial for COVID-19 treatment has also seen substantial progress, with over 650 patients enrolled in the monotherapy arm. The Independent Data Safety Monitoring Board (DSMB) is anticipated to conduct the first interim analysis in March 2024.
The Phase 2 study's open-label design involved 60 patients with HCV across all genotypes, who were given a daily dose of bemnifosbuvir and RZR for eight weeks. The preliminary findings indicate that the combination疗法 (combination therapy) is both safe and well-tolerated, with rapid viral load reduction observed in all patients. The primary endpoint of the study is to achieve SVR12, and the full study is expected to enroll approximately 280 patients by mid-2024, with results due in the third quarter of that year.
The SUNRISE-3 trial is a global, randomized, double-blind, placebo-controlled study that evaluates bemnifosbuvir alongside the standard of care for high-risk COVID-19 patients. The trial includes two interim analyses by the DSMB to assess safety and futility, with the first analysis expected in March 2024.
Bemnifosbuvir, a nucleotide polymerase inhibitor, has demonstrated significant activity against HCV genotypes 1–5 and is well-tolerated in clinical studies. RZR, an oral NS5A inhibitor, has shown potent antiviral activity and a favorable safety profile in over 1,200 HCV patients. For COVID-19, bemnifosbuvir targets the SARS-CoV-2 RNA polymerase, potentially offering a high resistance barrier due to its dual-action mechanism.
Atea Pharmaceuticals is dedicated to advancing oral antiviral therapies for serious viral infections, utilizing their expertise in antiviral drug development and nucleos(t)ide chemistry to create novel treatments for ssRNA viruses, which are common causes of severe viral diseases. The company aims to expand its pipeline by combining its nucleos(t)ide platform with other antiviral classes to enhance treatment options for patients.