Daewoong Pharmaceutical announced on Wednesday that it has completed patient recruitment for the global Phase 2 clinical trial of its fibrosis treatment candidate, Bersiporocin (DWN12088), targeting idiopathic pulmonary fibrosis (IPF).
The clinical trial is currently underway in both South Korea and the U.S. Researchers are evaluating the safety, tolerability, and efficacy of Bersiporocin, both as a standalone treatment and in combination with existing antifibrotic agents (nintedanib and pirfenidone).
Daewoong has been building a strong scientific foundation by presenting the design of the global Phase 2 trial and patient characteristic analyses at major conferences. The company is validating Bersiporocin’s potential in patient groups that closely mirror real-world clinical scenarios.
Looking ahead, Daewoong plans to leverage the results of the global Phase 2 trial, expected in Q1 2027, to pursue global partnerships and licensing opportunities. The company’s long-term strategy involves expanding its fibrosis treatment portfolio through diverse formulations and indications.
Bersiporocin is a groundbreaking first-in-class drug candidate. It works by selectively inhibiting prolyl-tRNA synthetase (PRS), a crucial enzyme in collagen production, thereby addressing the root cause of fibrosis.
The drug has garnered international recognition as a potential game-changer in global pharmaceuticals. It received orphan drug status from the U.S. Food and Drug Administration (FDA) in 2019, was selected for the FDA’s Fast Track program in 2022, and earned orphan drug designation from the European Medicines Agency (EMA).
Park Sung-soo, Chief Executive Officer (CEO) of Daewoong Pharmaceutical, stated that completing patient recruitment for this Phase 2 trial marks a crucial milestone in Bersiporocin’s development journey. They’re committed to enhancing Bersiporocin’s commercial viability based on robust global clinical data. The goal is to offer new treatment options to patients worldwide through strategic global partnerships.
Idiopathic pulmonary fibrosis is a chronic, progressive condition characterized by the gradual scarring of lung tissue. This leads to increasingly severe shortness of breath as the lungs’ ability to exchange oxygen deteriorates. The exact cause remains elusive, and current treatment options are limited in their ability to halt disease progression after diagnosis, making IPF one of the most challenging lung diseases to treat.