SK Biopharmaceuticals SKL27969 gets U.S. FDA trial nod

SK Biopharmaceuticals received approval to start Phase 1 and 2 clinical trials of SKL27969, an anti-cancer treatment candidate, in the United States, the company said Thursday.

SK Biopharmaceuticals logo

SK Biopharmaceuticals received approval to start Phase 1 and 2 clinical trials of SKL27969, an anti-cancer treatment candidate, in the United States, the company said Thursday.

With permission from U.S. Food and Drug Administration (FDA), the Phase 1 clinical trials will be conducted on 100 patients at 16 institutions to test the candidate’s safety and tolerability.

SKL27969 is a drug that works to control Protein Arginine Methyltransferase 5 (PRMT5). PRMT5 is a type of protein that has been shown to be overexpressed in many types of cancers, as well as negatively correlated with patient survival.

SK Biopharmaceuticals aims to develop SKL27969 as a treatment for brain disorders such as brain tumors. Preclinical trials produced meaningful results confirming the candidate’s efficacy, the company said.

“SKL27969 is SK Biopharmaceuticals’ first project to develop anti-cancer treatment,” said Cho Jeong-woo, CEO of SK Biopharmaceuticals. “We will endeavor to expand our capability to the anti-cancer treatment sector beyond the central nervous system sector.”

SK Biopharmaceuticals built its first anti-cancer drug research and development center in Pangyo, Gyeonggi, in 2017.

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