Daewoong Pharmaceutical said that it has won the go-ahead for its phase 1 clinical trial of DWN12088, idiopathic pulmonary fibrosis (IPF) treatment candidate, from Australia's Therapeutic Goods Administration.
|Daewoong headquarters in Samsung-dong, southern Seoul.|
The company plans to launch the clinical trial next month.
Ahead of the trial, the company also received an orphan drug designation from the U.S. Food and Drug Administration.
"We are set to launch a global clinical trial for DWN12088, the world's first PRS inhibitor, after receiving an ODD designation from the FDA," said Park Joon-seok, head of Daewoong's new drug center. "In addition to IPF, the company will expand research on various fibrosis diseases to strengthen its R&D capacity for rare diseases."
DWN12088 is an oral IPF therapy with a mechanism that selectively inhibits Prolyl-tRNA Synthetase (PRS) protein activity and excessive production of collagen. Preclinical studies have confirmed the efficacy and safety of the treatment compared to existing drugs.
IPF is an interstitial lung disease, in which the lung gradually hardens and loses its function. It is a rare disease that is difficult to treat and has a five-year survival rate of less than 40 percent.