SGIOY - Shionogi says COVID pill resolves Omicron symptoms faster meets trial's goal

Shionogi ( OTCPK:SGIOF ) ( OTCPK:SGIOY ) said its oral COVID-19 drug S-217622 helped patients achieve resolution of five Omicron-related symptoms faster, compared to placebo, thereby meeting the main goal of a phase 3 part of a phase 2/3 study conducted in Asia.

The study enrolled 1,821 patients in Japan, South Korea and Vietnam who had mild/moderate symptoms of COVID-19, irrespective of risk factors for severe complications. Majority of these patients were previously vaccinated.

The study evaluated S-217622 (ensitrelvir fumaric acid) in two dose groups, high dose and low dose, compared to placebo, the company said in a Sept. 28 press release.

The main goal of the trial was the time to first resolution of five key symptoms (stuffy or runny nose, sore throat, cough, feeling hot or feverish, and low energy or tiredness), which the company said are characteristic of infection with Omicron, in patients within 72 hours from the onset of symptoms.

Shionogi said that the median time to first resolution of the five symptoms was significantly reduced in those treated with the low dose of ensitrelvir (167.9 hours) compared to placebo (192.2 hours).

The company noted that the low dose of level is submitted for approval in Japan.

In addition, with respect to the key secondary goal of reduction in viral RNA on day 4 (following the third dose), ensitrelvir showed a significant difference versus placebo in the Least Squares mean change from baseline in viral RNA, the company noted.

Shionogi said in the low-dose group, the most common treatment-related adverse events were decreased high-density lipoprotein ( also known as good cholesterol) and increased blood triglycerides (type of fat) as seen in previous studies.

In July, a panel of the Japanese health ministry delayed emergency approval of the COVID-19 pill citing the need to continue discussions on the drug.

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