The primary endpoint of the SCORPIO-HR study was the time to sustained symptom resolution (the first day of two consecutive days with complete resolution of 15 common COVID-19-related symptoms).
Although ensitrelvir demonstrated a numerical reduction in the time to symptom resolution compared to placebo among participants treated within 3 days of symptom onset, the difference was not statistically significant.
A pre-defined supportive analysis of resolution of six symptoms for one day using a statistical method similar to that used in the SCORPIO-SR Study (Phase 3 part of the Phase 2/3 study of ensitrelvir conducted in Asia) yielded a significant difference (p<0.05) in the time to resolution of symptoms.
Ensitrelvir demonstrated a potent antiviral effect for both viral RNA and culture, compared to placebo.
Symptomatic viral rebound was not observed in this study, supporting previous findings from SCORPIO-SR.
Ensitrelvir did not demonstrate a statistically significant reduction in the proportion of participants with post COVID-19 symptoms (Long COVID) at three months, but there was a tendency for a higher proportion of participants to report “having returned to pre-COVID health” and “felt no fatigue” compared to placebo. Further detailed analysis is planned, including additional follow-up at six months.
No dysgeusia (drug-related abnormal taste) was reported.
No deaths were observed in either group up to Day 29 of follow up, and very few cases of COVID-19 related hospitalization were observed in either arm.
Shionogi will continue discussions with regulatory bodies and is committed to providing people worldwide with a potent COVID-19 antiviral treatment that is well-tolerated.
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