Atea Pharmaceuticals Completes Enrollment in Global Phase 3 COVID-19 Trial

Atea Pharmaceuticals, a clinical-stage biopharmaceutical company, has completed enrollment in its global Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir as a potential treatment for COVID-19 in high-risk outpatients, with results expected in the second half of 2024. The trial aims to assess the efficacy of bemnifosbuvir in reducing hospitalization and death rates among vulnerable populations, with implications for alleviating the burden on healthcare systems and mitigating the pandemic's economic and social impacts." This description focuses on the primary topic (Atea Pharmaceuticals' Phase 3 trial), main entities (Atea Pharmaceuticals, bemnifosbuvir, COVID-19), context (global pandemic), significant actions (completion of enrollment, expected results), and objective details (trial's purpose, target population) that will guide the AI in creating an accurate visual representation of the article's content.

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Nitish Verma
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Atea Pharmaceuticals Completes Enrollment in Global Phase 3 COVID-19 Trial

Atea Pharmaceuticals Completes Enrollment in Global Phase 3 COVID-19 Trial

Atea Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has reported its financial results for the first quarter of 2024 and provided a business update. The company announced the completion of enrollment in its global Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir for the treatment of COVID-19 in high-risk outpatients.

Why this matters: The development of effective treatments for COVID-19 remains crucial in protecting vulnerable populations and mitigating the economic and social impacts of the pandemic. A successful treatment could also help alleviate the burden on healthcare systems and pave the way for a return to normalcy.

The SUNRISE-3 trial has enrolled 2,221 patients in the supportive care monotherapy cohort and 74 patients in the combination cohort. Results from the trial are expected in the second half of 2024. "Our strong operational execution in combination with the surge of COVID-19 infections related to the JN-1 variant led to the completion of enrollment of high-risk patients in the global Phase 3 SUNRISE-3 study ahead of our guidance," said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea.

The SUNRISE-3 trial is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating bemnifosbuvir or placebo administered concurrently with locally available standard of care in high-risk outpatients with mild or moderate COVID-19. The primary endpoint is all-cause hospitalization or death through Day 29 in the supportive care monotherapy cohort. Secondary endpoints will measure patient outcomes through Day 60 post-treatment.

In addition to the COVID-19 program, Atea is conducting a global Phase 2 study evaluating the combination of bemnifosbuvir and ruzasvir in treatment-naïve hepatitis C virus (HCV) infected patients. The study is on track to report complete sustained virologic response at week 12 post-treatment (SVR12) results in the second half of 2024. Final results from the 60-patient lead-in cohort confirmed a 98% SVR4 rate across all genotypes from 58 of 59 patients.

Atea will present multiple presentations showcasing preclinical and new Phase 2 efficacy data at the European Association for the Study of the Liver (EASL) Congress 2024. "COVID-19 continues to be a threat, leaving the most vulnerable, including the elderly, immunocompromised, undervaccinated, and those with underlying risk factors, at risk for disease progression," added Dr. Sommadossi. "We look forward to reporting the results from SUNRISE-3 during the second half of 2024."

The completion of enrollment in the global Phase 3 SUNRISE-3 trial marks a significant milestone for Atea Pharmaceuticals in the development of bemnifosbuvir as a potential treatment for COVID-19. With results expected later this year, along with updates on the company's HCV program, Atea aims to make important strides in advancing oral antiviral therapies for patients in need.

Key Takeaways

  • Atea Pharmaceuticals completes enrollment in global Phase 3 SUNRISE-3 trial for COVID-19 treatment.
  • Trial evaluates bemnifosbuvir in high-risk outpatients with mild or moderate COVID-19.
  • Results expected in second half of 2024, with primary endpoint of all-cause hospitalization or death.
  • Atea also conducting Phase 2 study for hepatitis C virus treatment, with results expected in 2024.
  • Company to present preclinical and Phase 2 efficacy data at European Association for the Study of the Liver Congress 2024.