Ildong Pharmaceutical Changes Clinical Plan for Oral COVID-19 Treatment 'S-217622'

Significant Results in Phase 2a
Modification of Phase 2b/3 Clinical Trial Design

[Asia Economy Reporter Lee Gwan-joo] Ildong Pharmaceutical announced on the 15th that it will change the Phase 2b/3 clinical trial plan for the oral COVID-19 treatment ‘S-217622’ being developed by Shionogi Pharmaceutical.

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Ildong Pharmaceutical changed the original plan to conduct Phase 2b/3 trials simultaneously to separate Phase 2b and Phase 3 clinical trials for mild and moderate patients, in accordance with Shionogi’s clinical progress. However, the Phase 2b/3 trial for patients with asymptomatic and mild symptoms will proceed as originally planned.

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Recently, Shionogi Pharmaceutical announced the results of the Phase 2a trial of S-217622 in Japan. Regarding antiviral efficacy, the treatment group receiving S-217622 showed reductions in viral titers and viral RNA, and on the 4th day, the positive rate of viral titers decreased by 60-80% compared to the placebo group. Additionally, no cases of worsening requiring hospitalization or hospitalization-like treatment were observed in the treatment group, and no serious adverse events or abnormal cases were reported.

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Based on these results, the originally integrated Phase 2b and Phase 3 trials were separated to accelerate approval of S-217622 for mild and moderate patients. Shionogi Pharmaceutical also changed the clinical protocol and started the Phase 3 trial last week following the announcement of the Phase 2a results in Japan.

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Ildong Pharmaceutical and Shionogi explained, "We revised the clinical design considering not only the Phase 2a results but also overall changes related to COVID-19, such as the spread of the Omicron variant, expansion of vaccination, and increase in home treatment."

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