Shionogi’s COVID-19 Oral Drug and Nasal Vaccine Makes Headway in Trials

Japan’s Shionogi has made clinical progress on its COVID-19 oral drug and nasal spray vaccine. The Japanese firm said their oral drug entered Phase 2/3 clinical trial on September 27, while the nasal vaccine is expected to head into trials in the 2022 fiscal year.

Homegrown COVID-19 Oral Drug in Late-Stage Trial

Shionogi’s COVID-19 oral drug S-217622 is a 3CL protease inhibitor that can block the enzyme critical for virus reproduction. The trial recruited patients with mild or asymptomatic COVID-19, and give them either S-217622 or the placebo once daily for 5 days. The goal is to assess the efficacy and safety data of the antiviral drug.

The firm said that “mild COVID-19 patients or asymptomatic infected persons are mainly treated at home or overnight”, so the oral drug can potentially alleviate the burden on hospitals.

In the Phase 1 trial started in July 2021, S-217622 showed no serious safety issues, and the pharmacokinetics exceeds the target blood drug concentration. In animal models, the viral load quickly dropped after receiving the treatment.

Shionogi also announced the plan to produce 1 million doses of COVID-19 treatment for domestic use by March 2022.

Nasal Vaccine in Clinical Trial

On the other hand, Shionogi revealed that their nasal vaccine is scheduled to enter clinical trials in near future. The nasal vaccine is co-developed by Shionogi and the University of Tokyo spinoff HanaVax.

Under the deal signed July 2021, Shionogi will develop the vaccine with HanaVax’s drug delivery system and obtain the exclusive global rights to carry out vaccine research and commercialization. HanaVax will receive an upfront payment and milestones payment from Shionogi.

Additionally, Shionogi is considering launching a clinical trial for a COVID-19 booster shot which can be administered by intramuscular injection. The trial is expected to begin in 2021 and enter the market in March 2022.

Author

Tyler Chen

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