Ildong Pharmaceutical has started a Phase 2/3 clinical trial of S-217622, an investigational oral medication developed by its Japanese partner Shionogi Pharmaceutical to treat Covid-19 symptoms, at home, the South Korean company announced on Thursday.

The Ministry of Food and Drug Safety cleared the company’s IND application for a clinical study for the Covid-19 cure to evaluate its safety and pharmacological properties of the drug last week.

Under the protocol, Ildong Pharmaceutical plans to recruit more than 200 patients with asymptomatic and mild-to-moderate cases at Inha University Hospital in Korea, while Shionogi Pharmaceutical will conduct global clinical trials in Singapore and Japan among others.

Ildong Pharmaceutical aims to receive emergency use authorization for the drug in the first half of next year in Korea. Ildong Pharmaceutical expects it can sign on an agreement with its Japanese partner for technology transfer and local production of the drug for stable supply if granted marketing authorization.

S-217622 taken once daily for five days has demonstrated excellent safety and tolerability. It is known to inhibit 3CL-protease, present only in the Covid-19 virus, to prevent viral proliferation. In non-clinical studies, the treatment also showed a comparable level of viral inhibition across major Covid-19 variants, including Alpha, Beta, Gamma, and Delta.

During a recent virtual signing ceremony for the co-development agreement, Ildong CEO Yoon Woong-sub and Shionogi CEO Isao Teshirogi said that the joint development of S-217622 is not just for personal gain or business, but a social obligation of pharmaceutical companies to address the Covid-19 crisis.

Ildong Pharmaceutical shares traded 0.30 percent lower at 16,700 won ($13.99) in early afternoon on Friday.

By Han Jae-beom and Minu Kim

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