GNT Pharma's Nelonemdaz wins approval for Phase 3 trials

GNT Pharma's stroke treatment candidate Nelonemdaz [GNT PHARMA]

GNT Pharma's stroke treatment candidate Nelonemdaz won approval to start Phase 3 clinical trials in Korea, the company said Tuesday.

It is the first domestic stroke treatment candidate that received the nod to start Phase 3 clinical trials — the last round required for a drug.

With permission from the Ministry of Food and Drug Safety, the clinical trials will be conducted on a total of 496 patients suffering moderate to serve ischemic strokes in 23 university hospitals including Asan Medical Center. The company aims to test the efficacy of the drug on reducing disability and protecting brain cells.

The safety of Nelonemdaz was demonstrated in Phase 1 and 2 clinical trials, the company said. The Phase 1 clinical trial was completed in the United States and China on 165 people without diseases and Phase 2 clinical trial on 447 stroke patients in China and Korea.

"Since 1990, many global pharmaceutical companies have tried to develop treatment that can reduce disabilities and deaths caused by stroke, but they all have failed," said Gwag Byoung-joo, CEO of GNT Pharma. "Our goal is to successfully complete the Phase 3 clinical trials and release the drug by 2025."

GNT Pharma aims to go public this year. It selected Shinhan Investment as the main underwriter in July.

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