Shionogi & Co., Ltd. announced positive results from its Phase 3 SCORPIO-PEP trial, demonstrating that once-daily ensitrelvir significantly reduces the proportion of individuals developing symptomatic SARS-CoV-2 infection after exposure to household contacts with COVID-19. The double-blind, randomized, placebo-controlled global study met its primary endpoint, marking a significant step forward in COVID-19 prevention.
The SCORPIO-PEP trial (Stopping COVID-19 Progression with early Protease Inhibitor treatment – Post Exposure Prophylaxis) evaluated the efficacy and safety of ensitrelvir (ensitrelvir fumaric acid, S-217622) as a post-exposure prophylactic. Participants were administered ensitrelvir once daily, and the primary endpoint assessed the onset of COVID-19 symptoms through Day 10. The results indicated a statistically significant reduction in symptomatic SARS-CoV-2 infection in the ensitrelvir group compared to the placebo group.
"The findings from the SCORPIO-PEP trial are encouraging, suggesting that ensitrelvir could play a crucial role in preventing the spread of COVID-19 within households," said a lead researcher in the study. "The drug's ability to significantly reduce symptomatic infections following exposure could help to alleviate the burden on healthcare systems and protect vulnerable populations."
Ensitrelvir was reported to be well-tolerated by study participants, and no new safety concerns were identified during the trial. This favorable safety profile is an important consideration for a prophylactic treatment intended for use in individuals who may not yet be infected or symptomatic.
These results suggest that ensitrelvir has the potential to be a valuable tool in the fight against COVID-19, offering a means to prevent symptomatic infection in individuals exposed to the virus. Further details from the study will be presented at upcoming scientific conferences and in peer-reviewed publications.
