OSAKA, Japan, October 21, 2021 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President and CEO: Isao Teshirogi, Ph.D.; hereafter "Shionogi") presented results from non-clinical studies and from the Japanese Phase 1 clinical trial of S-217622, an investigational oral antiviral drug for COVID-19, caused by the novel coronavirus (SARS-CoV-2), at the International Society for Influenza and Other Respiratory Virus Diseases (ISIRV)-World Health Organization (WHO) Virtual Conference.
During ISIRV, the results of non-clinical drug efficacy and pharmacokinetic studies, and a summary of the results from the Japanese Phase 1 clinical trial1 which started in July 2021, were presented. The information presented is outlined below:
- S-217622 showed in vitro antiviral activity against a broad range of strains, including the δ strain.
- A dose-dependent viral reduction effect of S-217622 was observed in multiple animal studies.
- S-217622 showed a good drug metabolism and pharmacokinetics profile supporting oral dosing.
- Single oral administration of S-217622 to healthy Japanese subjects was safe and well tolerated.
- The once-daily oral dosing of S-217622 was predicted to exceed the target concentration required for the viral reduction effect from the non-clinical studies.
Based on these results, S-217622 has the potential to reduce SARS-CoV-2 viral load with once-daily oral administration.
Shionogi is committed to “Protect people worldwide from the threat of infectious diseases” as our key focus. We are not only pursuing the research and development of therapeutics, but are also working toward total care for infectious diseases, through awareness building, epidemic monitoring, prevention, diagnosis, and addressing exacerbations, as well as the treating of the infection itself. As SARS-CoV-2 continues to have a major impact on people’s lives and represents a global threat, we will seek to contribute to re-establishing the safety and security of society by developing new products and services to address this pandemic, and will keep all stakeholders informed regarding the progress of our efforts. For more information on our COVID-19 inititatives, please visit our website.
About S-217622
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References
1. Press elease on July 26, 2021. Notice Regarding the Initiation of a Phase 1 Clinical Trial for a COVID-19 Therapeutic Agent in Japan
2. Press release on September 28, 2021. Notice Regarding the Initiation of a Phase 2/3 Clinical Trial for a COVID-19 Therapeutic Agent in Japan