- Ongoing Phase 2 study enrolling 102 patients in the U.S. and South Korea, with more than 50% of participants identified as Asian
- Selectively inhibits collagen synthesis via PRS targeting, aiming to suppressing fibrosis progression
SEOUL, June 4, 2025 /PRNewswire/ -- Daewoong Pharmaceutical (Co-CEOs Seongsoo Park and Chang-Jae Lee) announced that it presented 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 to 21 in San Francisco.
The scientific poster was presented 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 also serves as the trial's global Coordinating Investigator and principal investigator.
The interim analysis highlighted key baseline demographic and clinical characteristics of enrolled participants, including racial distribution and antifibrotic medication use. Approximately 70% of participants were receiving Bersiporocin in combination with approved antifibrotic therapies (nintedanib or pirfenidone), while the remaining 30% participated without any background treatment. Notably, more than half of the enrolled patients are Asian- enabling exploratory assessment of treatment responses across ethnic subgroups, in contrast to prior IPF studies which were predominantly limited to White populations.
The ongoing randomized, double-blind, placebo-controlled Phase 2 study is being conducted at 30 sites in the U.S. and South Korea, targeting 102 IPF patients. Participants receive 150 mg of Bersiporocin or placebo twice daily for 24 weeks, with efficacy and safety assessed based on changes in forced vital capacity (FVC) and other clinical endpoints. As of April 2025, 80 patients (approximately 80% of target enrollment) had completed registration.
Bersiporocin is a first-in-class oral antifibrotic drug candidate developed by Daewoong Pharmaceutical. It selectively inhibits Prolyl-tRNA Synthetase (PRS), a key enzyme in proline activation and collagen biosynthesis. This targeted mechanism aims to interrupt the fibrotic cascade at its origin, potentially delivering more effective disease control with fewer off-target effects-positioning Bersiporocin as a next-generation therapeutic.
The drug was granted Orphan Drug Designation by both the U.S. FDA and the European Medicines Agency (EMA) in 2019, and has also received Fast Track designation from the FDA-affirming its potential as a globally significant treatment option for IPF.
"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," said Professor Jinwoo Song. "We look forward to providing safer and more effective treatment options for patients with IPF."
Seongsoo Park, CEO of Daewoong Pharmaceutical, added, "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."
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