Daewoong Pharmaceutical said Thursday it has completed patient enrollment for the global Phase 2 clinical trial of bersiporocin, a candidate treatment for idiopathic pulmonary fibrosis (IPF).
Bersiporocin works by selectively inhibiting prolyl-tRNA synthetase, a key enzyme in the collagen production process, thereby suppressing the root cause of fibrosis. The drug has received orphan drug designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and has been selected for the FDA's Fast Track program.
The trial is currently being conducted in Korea and the United States. It is evaluating the safety, tolerability, and efficacy of bersiporocin both as monotherapy and in combination with existing antifibrotic agents, nintedanib and pirfenidone. The trial is expected to be completed in the first quarter of next year.
Based on the global Phase 2 results, Daewoong Pharmaceutical plans to focus on global partnerships and technology licensing (license-out). Over the medium to long term, the company intends to expand formulations and indications to strengthen its fibrosis treatment portfolio.
"We will do our utmost to enhance the commercialization potential of bersiporocin based on clinical data and provide new treatment options to patients worldwide through global partnerships," Daewoong Pharmaceutical CEO Park Sung-soo said.
Meanwhile, Daewoong Pharmaceutical maintains one of the industry's highest research and development (R&D) investment ratios at 15.8% of revenue, and continues to develop novel drug pipelines for autoimmune, oncology, and metabolic diseases.
