Shionogi announces new Phase 3 data showing early resolution of many common COVID-19 symptoms in JAMA Network Open

Shionogi & Co Ltd announced on 13 Feb 2024 the first peer-reviewed publication of the Phase 3 portion of its pivotal, double-blind, randomized, placebo-controlled Phase 2/3 study (SCORPIO-SR) in patients with mild to moderate COVID-19 in Japan, South Korea and Vietnam in JAMA Network Open. The trial met its primary and key secondary endpoints, making ensitrelvir (generic name: ensitrelvir fumaric acid, Code No: S-217622, hereafter 'ensitrelvir') the first antiviral agent to show both clinical symptom improvement and antiviral effect in a predominantly vaccinated population with Omicron infection regardless of risk factors. The publication reports that treatment with once-daily ensitrelvir in the primary analysis population led to a statistically significant reduction in the time to resolution of five typical COVID-19 symptoms characteristic of Omicron (runny/stuffy nose, sore throat, cough, feeling hot or feverish, and low energy/tiredness1) versus placebo (p=0.04). The median time to symptom resolution was approximately one day shorter in the 125 mg ensitrelvir group versus placebo (approximately 7 days versus 8 days, respectively). Patients included in the primary analysis population were randomized less than 72 hours from symptom onset. More than 90% of patients had received two or more doses of the SARS-CoV-2 vaccine and patients were included regardless of risk factors for severe disease. Original source: Shionogi Inc, website: http://www.shionogi.com/, Copyright Shionogi Inc 2024.
research and development; antiviral agents; ensitrelvir fumaric acid; respiratory disease treatments; Shionogi & [...]