GeneOne's GLS-1027 approved for Phase 2 clinical trials by the EU
GLS-1027, GeneOne Life Science’s Covid-19 oral treatment candidate, received approval to start Phase 2 clinical trials from the European Medicines Agency (EMA) and Bulgaria, the company said Monday.
Bulgaria’s approval completes the roster for Phase 2 clinical trials. The company aims to conduct the trials in five jurisdictions — Korea, the United States, Puerto Rico, the Republic of Northern Macedonia and Bulgaria.
The Kospi-listed company plans to run the trials on a total of 132 Covid-19 patients with moderate or severe symptoms to test its safety and efficacy. The capsule-type treatment is formulated to prevent people from developing severe pneumonia.
“This is the first time GeneOne received approval from the EMA to start Phase 2 clinical trials. It would be an important milestone for us to expand our presence to not only in the United States, but also the European countries,” GeneOne Life Science CEO Park Young-keun said. “Bulgaria is currently suffering from the third wave of Covid-19, so we will accelerate gathering participants for the trials.”
GeneOne Life Science also said its animal testing of GLS-1027 produced results confirming effectiveness against the coronavirus, including its Beta variant, which was first identified in South Africa. 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.
GeneOne Life Science shares closed at 30,050 won ($26) Monday, up a 20 percent.
BY SARAH CHEA [firstname.lastname@example.org]