The trial met its primary endpoint and key secondary endpoints, making encitrevir the first antiviral drug to show both clinical improvement and antiviral efficacy in primarily vaccinated patients with Omicron infection. became.
The study found that once-daily encitrevir reduced the symptoms of five typical COVID-19 symptoms characteristic of Omicron: runny nose, sore throat, cough, fever, and fatigue compared to placebo. It was found that the time to resolution was statistically significantly shortened.
More than 90% of patients in the study had received at least two doses of SARS-CoV-2 vaccine, and patients were included regardless of risk factors for severe disease.
“We are pleased to present data from a Phase 3 study conducted in Asia in this peer-reviewed paper. “We are strengthening the potential of encitrevir across the world,” said Kenki Uehara, Shionogi’s senior vice president of drug development and regulatory science.
“Additionally, our findings suggest that encitrevir may reduce viral RNA levels and reduce the time it takes for viral titers to first become negative, potentially helping to reduce transmission of SARS-CoV-2. ” This study was conducted in a largely vaccinated population, including patients infected with Omicron. Patients also had various risk factors for severe disease. This is important because data are lacking and additional treatment options are needed for this population. ”
Encitrevir, known as Xocova in Japan, received emergency regulatory approval from Japan’s Ministry of Health, Labor and Welfare in 2022 for the treatment of SARS-CoV-2 infection.
Furthermore, although the treatment was approved in Singapore in November 2023 under a special access route application, it remains an investigational drug outside of Japan and Singapore. Encitrevir also received Fast Track designation from the U.S. Food and Drug Administration.
Despite the availability of vaccines and several treatments to treat COVID-19, the World Health Organization says the disease still needs more treatment options. he emphasized.
“As COVID-19 infections continue to surge, and the virus continues to evolve, adapt, infect, and reinfect people around the world, additional treatment options are available for more patients, regardless of their risk factors for severe disease. is necessary,” Yohei Doi said. , a professor at the Fujita Health University School of Medicine in Japan and one of the study authors.
“Comprehensive data from studies in Asia shows that encitrevir has promising potential to treat patients with many common COVID-19 symptoms.”
