Atea Pharmaceuticals Announces Positive Initial Data from Phase 2 Study for Hepatitis C Virus (HCV) and Significant Enrollment Milestone for Phase 3 SUNRISE-3 Trial for COVID-19 - Seite 3

SUNRISE-3 is a global, multicenter, randomized, double-blind, placebo-controlled, registrational Phase 3 trial evaluating bemnifosbuvir or placebo administered concurrently with locally available standard of care (SOC). The study has a large global footprint targeting approximately 300 clinical trial sites in the U.S., Europe, Japan and rest of the world. Patients are randomized 1:1 to receive either bemnifosbuvir 550 mg twice-daily (BID) or placebo BID for five days. SUNRISE-3 is the only Phase 3 program in high-risk COVID-19 patients with hospitalization as a primary endpoint.

This trial is comprised of two study populations based on the type of SOC received: 1) bemnifosbuvir as monotherapy (primary analysis), and 2) the “combination antiviral population,” assessing combination therapy if the SOC includes other compatible antiviral drugs against COVID-19 (secondary analysis).

The SUNRISE-3 patient population includes those aged ≥70 years (regardless of other risk factors), individuals aged ≥55 years with one or more risk factors, those aged ≥50 years with two or more risk factors, and individuals aged ≥18 years with specific risk factors, including immunocompromised conditions, all irrespective of COVID-19 vaccination status.

The primary endpoint of the trial is all-cause hospitalization or death through Day 29 post-treatment in the monotherapy arm in 2,200 patients. The trial includes two interim analyses by the DSMB to assess safety and futility, to be conducted after approximately 650 and 1,350 evaluable patients, respectively, after completion of Day 29 post treatment in the monotherapy arm.

About Bemnifosbuvir and Ruzasvir for HCV

Bemnifosbuvir, a nucleotide polymerase inhibitor, has been shown to be approximately 10-fold more active than sofosbuvir (SOF) in vitro against a panel of laboratory strains and clinical isolates of HCV genotypes 1–5. In vitro studies demonstrated bemnifosbuvir remained fully active against SOF resistance-associated strains (S282T), with up to 58-fold more potency than SOF. The pharmacokinetic (PK) profile of bemnifosbuvir supports once-daily dosing for the treatment of HCV and bemnifosbuvir has been well-tolerated at doses up to 550 mg for durations up to 8-12 weeks in healthy and HCV-infected subjects.