Daewoong Pharmaceutical announced Wednesday that it has completed patient enrollment for the global Phase 2 clinical trial of its idiopathic pulmonary fibrosis (IPF) treatment candidate, bersiporocin (DWN12088), marking a significant step in the company’s push to expand its innovative drug pipeline globally.
The multinational study is currently being conducted in both South Korea and the United States to evaluate the safety, tolerability and efficacy of bersiporocin in patients with IPF, a chronic and progressive lung disease with limited treatment options.
The trial is designed to assess not only bersiporocin as a standalone therapy, but also its use in combination with existing antifibrotic drugs such as nintedanib and pirfenidone, which are commonly prescribed for IPF treatment.
According to Daewoong Pharmaceutical, the completion of patient recruitment reflects stable progress in the company’s global clinical development program and strengthens the foundation for future global licensing-out and partnership discussions.
The company has also been building academic and scientific evidence for the therapy through presentations at major international conferences, including analyses of trial design and patient characteristics aimed at reflecting real-world clinical settings.
Daewoong Pharmaceutical said it plans to focus on global partnerships and licensing opportunities based on the Phase 2 trial results, which are expected in the first quarter of 2027. The company also intends to expand its fibrosis treatment portfolio over the long term through additional formulations and broader therapeutic indications.
Bersiporocin is a first-in-class drug candidate that selectively inhibits Prolyl-tRNA Synthetase (PRS), a key enzyme involved in collagen synthesis. By targeting collagen production, the therapy aims to suppress the underlying mechanisms of fibrosis rather than only managing symptoms.
The candidate has already received several regulatory recognitions, including orphan drug designation from the U.S. Food and Drug Administration in 2019, Fast Track designation from the FDA in 2022 and orphan drug designation from the European Medicines Agency.
Daewoong Pharmaceutical has continued to expand research and development spending, maintaining an R&D investment ratio of 15.8% of sales, one of the highest levels in the Korean pharmaceutical industry. The company is also strengthening pipelines in autoimmune diseases, oncology and metabolic disorders.
Park Sung-soo, CEO of Daewoong Pharmaceutical, said the completion of enrollment represents a major turning point in the development of bersiporocin and added that the company aims to provide new treatment options for patients worldwide through global partnerships and commercialization efforts.
