GeneOne Life Science wins EMA nod for phase 2 clinical study of COVID-19 treatment

GeneOne Life Science’s investigational oral drug for COVID-19 has received regulatory approvals from the European Medicines Agency and Bulgaria to conduct a phase 2 clinical trial in Bulgaria, the Korean biotech firm said Monday.

The Balkan nation is among the five regions where GeneOne Life Science plans to conduct phase 2 studies of GLS-1027. It is also the last of the five to give the company a go-ahead. The four others are the US, South Korea, Puerto Rico and North Macedonia.

GeneOne Life Science plans to confirm GLS-1027’s therapeutic effect on a total of 132 patients infected with COVID-19 and its variants through safety and efficacy tests.

GLS-1027 is being developed as an oral pill that could suppress severe pneumonia caused by COVID-19 infection.

In animal tests, it showed therapeutic effects on pneumonia caused by the coronavirus.

GeneOne Life Science hopes that the drug candidate could also be applied to treat other autoimmune diseases.


By Shim Woo-hyun (ws@heraldcorp.com)