GeneOne's oral Covid treatment gets Phase 2 approval

A GeneOne Life Science researcher conducts a test in the company's lab in Gangnam, southern Seoul. [YONHAP]

GeneOne Life Science’s Covid-19 oral treatment candidate GLS-1027 won approval to start Phase 2 clinical trials in Korea, the company said Thursday.

Korea was the fourth territory that gave the company approval for Phase 2 clinical trials. The company aims to conduct the trials in a total of five places — Korea, the United States, Puerto Rico, the Republic of Northern Macedonia and Bulgaria — and is still awaiting approval from Bulgaria.

The Kospi-listed company plans to run the trials on a total of 132 Covid-19 patients with moderate and severe symptoms to test its safety and efficacy. The capsule-type treatment aims to prevent people from developing severe pneumonia.

“We approved the Phase 2 clinical trials of GLS-1027 as the results of Phase 1 clinical trials showed enough safety and tolerability,” the Ministry of Food and Drug Safety said.

On Thursday, GeneOne Life Science also said animal tests of the oral treatment have produced results confirming its effectiveness. The company injected the treatment into hamsters that were infected with the virus, and found that they only had mild inflammation on parts of their lungs. Those in the control group developed serious pneumonia.

“The importance of Covid-19 treatment that can effectively treat pneumonia has been growing as many companies that have been developing treatments have failed to show meaningful results with ongoing clinical trials,” said GeneOne Life Science CEO Park Young-keun. “GLS-1027 has great potential as it can be applied to not only Covid-19 but also in various autoimmune diseases.”

GeneOne Life Science shares closed at 38,700 won ($33) on Thursday, a 7.35 percent jump from the previous trading session.

Currently in Korea, a total of 14 Covid-19 treatment candidates have been undergoing clinical trials. Of them, five are oral treatments.

BY SARAH CHEA [chea.sarah@joongang.co.kr]