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Japan-based Shionogi & Co., Ltd. announced new results from two late-breaking presentations of S-217622 at the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Lisbon, 23 – 26 April. S-217622 is an investigational 3CL protease inhibitor that was studied for once-daily oral administration in mainly vaccinated patients (~85%), with no risk factors for severe complications, within five days of COVID-19 symptom onset.
At the meeting, Shionogi presented new late-breaking Phase 2b results from the Phase 2/3 clinical trial of S-217622, completed in Asia.
These new data showed S-217622 demonstrated rapid clearance of the infectious SARS-CoV-2 virus.
On day four of treatment (following the third dose), the proportion of patients with positive viral titer decreased by approximately 90% versus placebo.
S-217622 shortened infectious virus shedding by 1-2 days versus placebo.
S-217622 showed a significant reduction in viral RNA on days 2, 4, 6 and 9 versus placebo (difference versus placebo in the Least Squares mean change from baseline in viral RNA; under -1.0 logx copies/mL on day four at each dose).
There was no significant difference in total score of 12 COVID-19 symptoms between treatment arms, however, S-217622 showed improvement in composite score of five “respiratory and feverish” symptoms (post-hoc analysis).
A separate global Phase 3 study of S-217622 is underway aiming to recruit participants globally to support regulatory filings this year.
