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 2

The initial results for the first 52 patients who reached this timepoint demonstrated a SVR4 rate of 98%, including one patient with poor adherence who did not achieve SVR4. Additionally, very rapid kinetics were observed in all 60 patients across genotypes with viral load near or below the lower limit of quantification (LLOQ) at 4 weeks of treatment, which is supportive of an 8-week treatment regimen for the combination of bemnifosbuvir and RZR. All 60 patients achieved viral load below the LLOQ at the end of the treatment. The combination was generally safe and well tolerated. There were no drug related serious adverse events, no treatment discontinuations and adverse events were mostly mild.

The Phase 2 study aims to assess the safety and efficacy of 8 weeks of treatment with the combination of bemnifosbuvir and RZR in treatment-naïve HCV-infected patients, either without cirrhosis and or with compensated cirrhosis. The primary endpoint of the study is SVR12.

Approximately 280 treatment-naïve HCV-infected patients, including the lead-in cohort, are expected to be enrolled in the Phase 2 study. The second part of the trial is anticipated to enroll 220 patients across all genotypes. An expanded geographic footprint to include approximately 50 clinical sites in approximately 15 countries is currently being activated. Full enrollment of the study is expected to be completed by mid-2024 with topline results in the third quarter of 2024.

Phase 3 SUNRISE-3 Trial Enrollment Update

“Patient enrollment for SUNRISE-3 is currently correlating with the winter wave, and the high incidence of COVID-19 infection early in this winter season has led to more than 650 patients being enrolled. This is an important milestone, which allows for the first interim analysis by the independent DSMB for safety and futility, and the analysis is expected this March,” continued Dr. Sommadossi. “COVID-19 remains a continuing threat to many worldwide, with the levels in wastewater higher than this time last year, and COVID-19 continues to be a leading driver of respiratory virus hospitalizations. There is a need for new treatment options to protect those who are most vulnerable to severe outcomes after infection such as the elderly, immunocompromised and those with underlying risk factors.”