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Notice Regarding the Initiation of a Phase 2/3 Clinical Trial

Shionogi & Co., Ltd. announced that Shionogi has initiated a Japanese Phase 2/3 clinical trial of S-217622, an orally administered antiviral drug for COVID-19, caused by the novel coronavirus (SARS-CoV-2) on September 27. Prior to this, a Japanese Phase 1 clinical trial was initiated in July 2021, and, in this clinical trial, the safety results support progression and pharmacokinetic analyses confirm that blood drug concentrations meeting or exceeding the target concentration are achieved.

The Phase 2/3 clinical trial will evaluate the efficacy and safety of oral administration of this drug once daily for 5 days in patients with mild COVID-19 or asymptomatic SARS-CoV-2 infection, in comparison with placebo. Currently, in Japan, mild COVID-19 patients or asymptomatic infected people are mainly recovering at home or in accommodation facilities. Therefore, this study will recruit not only at medical facilities but also at accommodation facilities, in collaboration with medical institiutions, as COVID-19 can rapidly become severe even if it is initially mild or asymptomatic. In addition, although there is a placebo arm to the study, sufficient medical support from doctors and nurses will be provided for subjects throughout the trial period.

Currently, antibody therapy is approved treatment for mild COVID-19 patients in Japan. Antibody  therapy has not been widely used because it is intended for patients at increased risk of exacerbation, and requires certain medical resources for infusion and patient monitaring. With the medical system currently under intense pressure, with limited treatment options, oral antiviral drugs that can reduce viral burden from the initial stages of infection and are easy to use are required. This therapeutic agent is expected to contribute to the early treatment of patients and to help to relieve the pressure on the medical system.

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Pharmaceutical Drug Delivery Market - Global Forecast to 2026

by Route of Administration (Oral, Injectors, Implantable, Syrups, Gels, Pulmonary, Solutions, Tablets, Syringes), Application (Cancer, Diabetes), Facility of Use (Hospitals), COVID-19 Impact

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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 towards total care for infectious diseases, through awareness building, epidemic monitoring, prevention, diagnosis, and addressing exacerbations, as well as the treating the infection itself. As SARS-CoV-2 continues to have a major impact on people’s lives and to represent 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.

About S-217622
S-217622, a therapeutic drug for COVID-19, is a 3CL protease inhibitor created through joint research between Hokkaido University and Shionogi. The new coronavirus (SARS-CoV-2) has an enzyme called 3CL protease, which is essential for the replication of the virus. S-217622 suppresses the replication of SARS-CoV-2 by selectively inhibiting 3CL protease. In non-clinical trials using SARS-CoV-2 infected animals, it has been confirmed that the viral load is rapidly and significantly reduced. Japanese Phase 1 clinical trials began in July 20211, and a Phase 2/3 clinical trial is currently underway in mild or asymptomatic COVID-19 patients.

Source: Shionogi
Date: Sep 28, 2021

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