Ildong applies to change trial protocol after completion

By Kim, Jin-Gu | translator Alice Kang

22.09.28 12:04:57

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Applies to modify Phase 2/3 trial for Xocova...will reduce the size of the global Phase 3 trial from 1811 to 780

Will reinterpret clinical trial results focusing on the Omicron variant...”to raise the possibility of receiving Special Approval for Emergency in Japan”

Ildong Pharmaceutical and Shionogi Pharmaceutical submitted an application to modify their clinical trial protocol after completing the Phase 3 trial for their COVID-19 treatment. The industry saw this as Shionogi Pharmaceutical’s intent to reinterpret the clinical trial results around the Omicron variant.

On the 27th, Ildong Pharmaceutical publicly announced that it applied to modify the Phase 2/3 clinical trial protocol for its oral COVID-19 treatment candidate 'S-217622 (brand name: Xocova).’

According to the public announcement, the biggest change was made in Cohort A’s Phase III trial size that is being conducted on moderate-to-severe COVID-19 patients.

Cohort A

Kim, Jin-Gu(kjg@dailypharm.com)

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