Shinpoong Pharmaceutical said Thursday it has sought a regulatory nod to change the phase 3 clinical trial plan using Pyramax, its antimalarial treatment, as a Covid-19 treatment.

The primary endpoint of the existing clinical trial plan was set up as the proportion of subjects in hospitalization or death due to infection when using the treatment.

However, the company wants to add to the primary endpoint, “the time until all Covid-19 symptoms disappear after infection.”

The company stressed that the change in its clinical trial plan reflects the recommendations of the independent data monitoring committee.

According to the company, the independent data monitoring committee recommended the new primary endpoint as the recent prevalence of Omicron and the increase in vaccination rates have resulted in a decrease in the number of severe cases.

Shinpoong also plans to increase the number of subjects for phase 3 clinical trials from 1,420 to 1,676.

However, Shinpoong said a change in the phase 3 clinical trial plan would not have a significant impact on the clinical development schedule of Pyramax.

"The effect of this clinical trial plan change on the Korean clinical participant registration and interim analysis schedule will be minimal,” a company official said. “The company will adjust the global clinical progress, and final outcome analysis schedule after the changed trial plan receives approval from regulators.”

Shinpoong had been working to repurpose Pyramax as a Covid-19 pill since the early stages of the Covid-19 pandemic. The company applied for a global phase 3 trial of Pyramax to the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) on Jan. 19.

In Korea, Shinpoong won the nod for a phase 3 study last year and registered the first patient on Oct. 18.

The drugmaker had planned to recruit 1,420 patients for the Pyramax Covid-19 treatment trial in seven countries, including Korea, the U.K., Poland, Russia, Argentina, Chile, and the Philippines.