The primary endpoint of the SUNRISE-3 trial is all-cause hospitalization or death through Day 29 in the supportive care monotherapy cohort. In addition, secondary endpoints will measure patient outcomes in the trial through Day 60 post-treatment.
The trial is comprised of two study populations based on the type of SOC administered at the investigator’s discretion: 1) the “supportive care
population,” evaluating 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). In this study, 2,221 patients were randomized into the supportive care monotherapy cohort and only 74 patients were randomized into the combination cohort, with 77% enrolled in the US.
The clear preference by investigators to enroll patients in the monotherapy cohort highlights the continuing unmet medical need for new oral COVID-19 treatment options for high-risk patients.
The SUNRISE-3 high-risk patient population consists of 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, irrespective of COVID-19 vaccination status.
The evaluation of bemnifosbuvir for the treatment of
COVID-19 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA).
COVID-19 Program for Second Generation Protease Inhibitors: As part of a multi-pronged approach against COVID-19, Atea is engaged in efforts directed to the
identification of second-generation protease inhibitors. Activities to select a novel proprietary compound with a differentiated profile are underway.
Hepatitis C Virus (HCV) Phase 2 Update
Phase 2
HCV Combination Study: Atea is currently conducting a global Phase 2 clinical trial of bemnifosbuvir, an oral nucleotide NS5B polymerase inhibitor, in combination with ruzasvir, an oral NS5A inhibitor, in
treatment-naïve, HCV-infected patients either without cirrhosis or with compensated cirrhosis. This study is designed to evaluate the safety and efficacy of
eight weeks of treatment with the combination consisting of once-daily bemnifosbuvir 550 mg and ruzasvir 180 mg.
Up to approximately 280 HCV-infected, treatment-naïve patients across all genotypes, including the lead-in cohort of 60 patients without cirrhosis, are
expected to be enrolled in this Phase 2 clinical trial. The primary endpoints of the study are safety and sustained virologic response (SVR) at Week 12 post-treatment (SVR12). Other virologic endpoints include virologic failure, SVR at Week 24
post-treatment (SVR24) and resistance.
Final results from the 60-patient
lead-in cohort confirmed a 98% SVR4 rate across all genotypes from 58 of 59 patients. These results, which are consistent with the initial results from this cohort announced in January 2024, include a
patient with poor adherence who did not achieve SVR4 and exclude one patient who did not attend the Week 4 post-treatment follow-up.
The SVR4 rate exceeded the protocol-defined efficacy criterion of ≥90% SVR4 for continuing the study. As a result, in January 2024, patient
enrollment was reinitiated for up to 220 additional patients, including patients with cirrhosis. Topline results from all patients enrolled in the Phase 2 study are anticipated in the second half of 2024.
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