With the amendment, the patient population will be expanded to include patients ≥70 years old (regardless of other risk factors), patients ≥55 years old with one or more risk factors, patients ≥50 years old with two or more risk factors and patients ≥18 years old with certain risk factors including immunocompromised conditions, all regardless of COVID-19 vaccination status. Also, patients with decreased renal function will be eligible for the trial.
Additionally, considering the currently observed low rates of hospitalization and death, the amendment modifies the trial from an adaptive design to a static design targeting enrollment of a fixed number of approximately 2,200 patients in the supportive care (monotherapy) arm compared with the original protocol which targeted approximately 1,300 patients in the same arm but allowed for a potential sample size re-estimation and increase following an interim analysis. The amendment also incorporates two interim analyses for review by the data and safety monitoring board principally for safety and futility after approximately 650 and 1,350 evaluable patients, respectively, in the supportive care (monotherapy) arm have completed Day 29.
Bemnifosbuvir SUNRISE-3 Trial in High-Risk Outpatients with COVID-19: Patient enrollment continues in the global, multicenter, randomized, double-blind, placebo-controlled, registrational Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir, a nucleotide polymerase inhibitor, or placebo administered concurrently with locally available standard of care (SOC). SUNRISE-3 has a global footprint with a target of approximately 330 clinical sites in approximately 30 countries and is designed to enroll high-risk outpatients with mild or moderate COVID-19 at clinical trial sites worldwide, including in the U.S., Europe, and Japan. Patients are being randomized 1:1 to receive either bemnifosbuvir 550 mg twice-daily (BID) or placebo BID for five days.
The trial consists of two study populations derived from the type of SOC received: 1) “supportive care population” (those patients who do not qualify for an approved antiviral treatment or where antivirals are not locally available), which will assess bemnifosbuvir given as monotherapy (primary analysis) and 2) “combination antiviral population”, which will assess combination therapy if the SOC includes treatment with other compatible antiviral drugs against COVID-19 (secondary analysis).
The primary endpoint of the SUNRISE-3 study is all-cause hospitalization or death through Day 29 in the supportive care (monotherapy) arm and is powered to detect a clinically meaningful reduction in hospitalization or death versus placebo in this population.
Granted Fast Track Designation by U.S. FDA: In April 2023, Atea announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to investigate bemnifosbuvir for the treatment of COVID-19. The FDA’s Fast Track program is designed to facilitate the expedited development and review of new drugs or biologics that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. Among other things, as a result of the Fast Track designation, Atea may benefit from more frequent communications with the FDA to discuss the development plan of bemnifosbuvir for the treatment of COVID-19 and rolling review of any completed sections of any resulting New Drug Application.
Presentation of Data Showing Bemnifosbuvir Reduced Risk of Hospitalizations for COVID-19 Patients at 2023 European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2023): In April 2023, Atea presented the full results from the MORNINGSKY trial, which evaluated bemnifosbuvir for the treatment of mild to moderate COVID-19. As previously announced, these results showed that non-hospitalized adult and adolescent patients who received bemnifosbuvir experienced a 71% relative reduction in risk of hospitalization, regardless of vaccination status (secondary endpoint). In an exploratory analysis, an 82% reduction in risk of hospitalization was seen in a subset of patients greater than 40 years of age. Based on these data, the global Phase 3 SUNRISE-3 registrational trial was initiated.
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