Phase III part of Asian trial of S-217622 meets primary endpoint in COVID-19
Shionogi announced that S-217622 (ensitrelvir fumaric acid), an investigational, 3CL protease inhibitor, administered once daily for five days, being evaluated as an antiviral treatment for COVID-19, achieved the primary endpoint in the Phase III part of a Phase II/III study conducted in Asia
This study was conducted in patients with mild/moderate symptoms of COVID-19 and assessed clinical symptom resolution with ensitrelvir (2 dose groups; high dose and low dose), orally administered once daily for five days, compared to placebo. A total of 1,821 patients were enrolled, in Japan, South Korea, and Vietnam, irrespective of risk factors for COVID-19 progression.
The majority of patients were previously vaccinated. The primary endpoint in the study was the time to first resolution of five key COVID-19 symptoms (stuffy or runny nose, sore throat, cough, feeling hot or feverish, and low energy or tiredness) which are characteristic of infection with the SARS-CoV-2 Omicron variant, in patients randomized within 72 hours from the onset of symptoms. The five assessed symptoms were selected in consultation with medical experts and regulatory authorities including the Ministry of Health, Labor and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and the FDA, based on their scientific and medical validity.
In this population, the median time to first resolution of the five COVID-19 symptoms was significantly reduced in those treated with the low dose of ensitrelvir (the dose level submitted for approval in Japan) compared to placebo: 167.9 hours versus 192.2 hours, a statistically significant difference of 24 hours (p=0.04). In addition, with respect to the key secondary endpoint of reduction in viral RNA on day 4 (following the third dose), ensitrelvir showed a significant difference versus placebo (p<0.0001) in the least squares mean change from baseline in viral rna; a reduction of more than 1.4 log10 copies ml versus placebo, similar to the results observed in previous studies. with regard to safety, both doses of ensitrelvir were well tolerated, and there were no serious adverse events or deaths in this study. in the low-dose group, the most common treatment-related adverse events were decreased high-density lipoprotein and increased blood triglycerides, as observed in previous studies.
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