Ildong Pharmaceutical has requested for changing its previous application for oral Covid-19 treatment candidate substance, Xocova (S-217622).

In a public notice Tuesday, Ildong said it had applied to the Ministry of Food and Drug Safety to approve the change in phase 2/3 clinical trial of an investigational new drug (IND) S-217622.

“Shionogi & Co. applied for and received approval for a change in clinical trial plan to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) on Sept. 20. Accordingly, Ildong Pharmaceutical has also applied to the Ministry of Food and Drug Safety to change its clinical trial plan,” Ildong said.

As to what has changed specifically in IND application, Ildong said it was a change in clinical protocol to reflect the recent Covid-19 situations, including the Omicron variant. The company has finished dosing patients but has not locked the data yet, and therefore, it is still possible to change protocols by, for instance, making a change in patient samples.

Ildong has submitted a clinical trial completion report to the food and drug safety ministry after finishing the observation of the subjects on Aug. 14.

On Feb. 25, Japan’s Shionogi, the original developer of S-217622, applied for conditional approval of S-217622 to the Japanese Ministry of Health, Labor and Welfare. On June 22, the emergency use application bill passed a specialized division meeting of the ministry, but participants decided to discuss it again at the ministry’s pharmaceutical and food sanitation council, according to Ildong.

On July 20, the Japanese ministry held the pharmaceutical and food sanitation council and discussed the emergency use approval of S-217622, but decided to have an additional discussion later.

“We plan to issue another public notice if we receive the topline results according to the changed clinical trial plan Tuesday,” Ildong said. “The company is looking forward to its potential as a Covid-19 treatment.”