Ildong applies to change trial protocol after completion

Why did the company apply to modify its clinical trial protocol after completing its Phase 3 trial?

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’s Phase 2b trial size had been 428, and Phase 3 1821.

 

Through the modification, Ildong and Shionogi decided to increase the Phase 2b trial size for Cohort A to 435, and reduce the Phase 3 trial size to 780.

 

The size of Phase 2b and Phase 3 trials for Cohort B, which are being conducted concurrently and enrolled asymptomatic and mild COVID-19 patients, will also be reduced from 605 to 495.

 

However, the number of participants enrolled in Cohort A and Cohort B are not that different in Korea, 204 and 200, respectively.

 

The reason why the modification application had been receiving interest was that the two companies had already completed the global Phase III trial for Xocova.

 

The two companies completed observation of the final trial participant on August 14th and submitted the clinical trial completion report to regulatory authorities.

 

This is why the industry analyzes the companies’ applied for the change to reinterpret the clinical trial results, focusing on the Omicron variant.

 

When the clinical trial was first designed, the company enrolled COVID-19 patients infected with the original (Wuhan) strain and Omicron variant in Korea.

 

However, as time went by, the Omicron variant became the dominant strain, which naturally shifted the treatment target to the Omicron variant as well.

 

At the same time, some industry experts analyzed that the reinterpretation of clinical trial results was Shionogi’s strategy to raise the possibility of receiving Special Approval for Emergency in Japan.

 

Shionogi submitted an application for the conditional approval of Xocova to Japan’s Ministry of Health, Labor and Welfare in February this year.

 

After the bill for the Special Approval for Emergency was passed in Japan, emergency use of Xocova had been discussed by MHLW’s expert committee.

 

However, the conclusion was for the agenda to be redeliberated by MHLW’s Pharmaceutical Affairs and Food Sanitation Council.

 

Although a second discussion was made by the council in July, the council decided to further discuss the issue in the future.

 

An official from Ildong Pharmaceutical said, “The application for modification that was submitted this time was led by Shionogi.

 

The company is known to have filed the application to re-review the result around subjects affected by the Omicron variant in line with the current situation where the Omicron variant is the dominant strain.”