SEOUL, South Korea – June 3, 2025 – Daewoong Pharmaceutical (Co-CEOs Seongsoo Park and Chang-Jae Lee) today announced the presentation of interim results from a global Phase 2 clinical trial of its investigational idiopathic pulmonary fibrosis (IPF) treatment candidate, Bersiporocin (DWN12088), at the 2025 American Thoracic Society (ATS) International Conference, held from May 16–21 in San Francisco.
Key Presentation Highlights
The data were presented as a scientific poster during the official ATS session titled “WHAT'S NEW IN ILD DIAGNOSIS, MONITORING, AND TREATMENT” on May 18 by Dr. Jinwoo Song, Professor of Pulmonology at Asan Medical Center, who is serving as the trial’s global Coordinating Investigator and principal investigator.
Study Design & Demographics
The ongoing, randomized, double-blind, placebo-controlled Phase 2 trial is being conducted at 30 clinical sites across the U.S. and South Korea, enrolling 102 patients with IPF. Participants are receiving either 150 mg of Bersiporocin or placebo twice daily for 24 weeks.
Key points from the interim analysis include:
- 80 patients (approximately 80%) had completed enrollment as of April 2025.
- Over 50% of patients are Asian, enabling comparative analysis across ethnic groups—unlike previous IPF studies dominated by White populations.
- Approximately 70% of patients are receiving Bersiporocin in combination with existing antifibrotic treatments (nintedanib or pirfenidone), while 30% are on monotherapy.
Clinical outcomes are being measured primarily through changes in forced vital capacity (FVC) and other secondary safety and efficacy endpoints.
Mechanism of Action & Global Designations
Bersiporocin is a first-in-class oral antifibrotic drug that selectively inhibits Prolyl-tRNA Synthetase (PRS)—a key enzyme involved in proline activation and collagen biosynthesis. By targeting the origin of the fibrotic cascade, Bersiporocin aims to minimize off-target effects and offer enhanced disease control.
The drug has received the following global regulatory designations:
- Orphan Drug Designation from the U.S. FDA and European Medicines Agency (EMA) (2019)
- Fast Track Designation from the U.S. FDA
Leadership Commentary
“This trial not only offers hope for a new treatment option, but also allows us to assess responses across a racially diverse patient population, including Asian patients,”
- Dr. Jinwoo Song, Principal Investigator
“Bersiporocin represents a breakthrough in antifibrotic therapy by targeting the root cause of fibrosis through PRS inhibition. We are committed to advancing this program to help redefine the global IPF treatment paradigm,”
- Seongsoo Park, CEO, Daewoong Pharmaceutical
