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• The P-II/III (SCORPIO-SR) trial evaluates Ensitrelvir (125/250mg) vs PBO in patients (n=1,821) with mild to moderate COVID-19 across Japan, South Korea & Vietnam. The 1EP was time to resolution of 5 COVID-19 symptoms & 2EPs were change from baseline in SARS-CoV-2 RNA level on day 4 & time to first negative SARS-CoV-2 titer
• The results showed a median time to symptom resolution of 167.9hrs. vs 192.2hrs., change from baseline in SARS-CoV-2 RNA level of −2.48 log10 copies/mL vs −1.01 log10 copies/mL & a 36.2hrs. vs -29.1hrs. difference in the first negative SARS-CoV-2 titer. The results were published in JAMA Network Open
• Ensitrelvir (oral antiviral drug) was approved in Japan in 2022 (by Xocova), in Singapore in Nov 2023 & was granted the US FDA’s FTD for COVID-19 treatment

Ref: Shionogi | Image: Shionogi

Related News:- Shionogi Initiated P-I/II/III Clinical Trial (Part 2) and P-III Additional Dose Clinical Trial of S-268019 for COVID-19

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