Daewoong Pharmaceutical Completes Patient Enrollment for Global Phase 2 IPF Trial of Fibrosis Treatment Candidate Bersiporocin

Daewoong Pharmaceutical announced on May 6 that it has completed patient enrollment for the global Phase 2 clinical trial (NCT05389215) of its idiopathic pulmonary fibrosis (IPF) treatment candidate, bersiporocin (DWN12088).

Researchers at Daewoong Pharmaceutical conducting a study. Daewoong Pharmaceutical

The company explained that the completion of patient enrollment marks a significant milestone, demonstrating that the global clinical development of bersiporocin is progressing smoothly and laying the groundwork for accelerating discussions on potential global technology licensing deals in the future.

The clinical trial is currently underway in both Korea and the United States, evaluating the safety, tolerability, and efficacy of bersiporocin both as a monotherapy and in combination with existing antifibrotic drugs (nintedanib and pirfenidone).

Daewoong Pharmaceutical has been building scientific evidence by presenting the study design and patient characteristic analysis results of the global Phase 2 trial at major academic conferences. The company is validating the potential of bersiporocin in patient groups that reflect real-world clinical settings.

Based on the results of the global Phase 2 trial, which are expected in the first quarter of 2027, Daewoong Pharmaceutical plans to focus on global partnerships and out-licensing opportunities. In the mid- to long-term, the company aims to expand its fibrosis treatment portfolio through the development of various formulations and indications.

Bersiporocin is a first-in-class innovative drug candidate that selectively inhibits prolyl-tRNA synthetase (PRS), a key enzyme involved in collagen synthesis, thereby targeting the root cause of fibrosis. The compound was designated an orphan drug by the U.S. Food and Drug Administration (FDA) in 2019, selected for the FDA’s Fast Track program in 2022, and also received orphan drug designation from the European Medicines Agency (EMA).

Seongsu Park, CEO of Daewoong Pharmaceutical, stated, "The completion of patient enrollment for the global Phase 2 IPF trial is a pivotal turning point for the development of bersiporocin. We will do our utmost to enhance the commercial potential of bersiporocin based on global clinical data and to provide new treatment options to patients worldwide through global partnerships."

This content was produced with the assistance of AI translation services.