Daewoong Pharmaceutical Advances Phase 2 Trial of Novel IPF Drug Bersiporocin with Diverse Patient Population
核心洞察
Daewoong Pharmaceutical (搜索) presented interim Phase 2 results for Bersiporocin (DWN12088), a first-in-class oral antifibrotic drug targeting idiopathic pulmonary fibrosis (搜索), at the 2025 American Thoracic Society (搜索) International Conference.
The ongoing randomized, double-blind, placebo-controlled study is enrolling 102 patients across 30 sites in the U.S. and South Korea, with over 50% of participants being Asian, enabling assessment across ethnic subgroups.
Bersiporocin selectively inhibits Prolyl-tRNA Synthetase (搜索) (PRS (搜索)) to interrupt collagen biosynthesis and fibrotic cascade progression, representing a novel mechanism of action in IPF (搜索) treatment.
Daewoong Pharmaceutical (搜索) presented interim results from its global Phase 2 clinical trial of Bersiporocin (DWN12088), an investigational treatment for idiopathic pulmonary fibrosis (搜索) (IPF (搜索)), at the 2025 American Thoracic Society (搜索) International Conference held in San Francisco from May 16 to 21. The scientific poster was presented during the "WHAT'S NEW IN ILD DIAGNOSIS, MONITORING, AND TREATMENT" session on May 18 by Dr. Jinwoo Song, Professor of Pulmonology at Asan Medical Center and the trial's global Coordinating Investigator.
Novel Mechanism Targets Fibrosis at Its Origin
Bersiporocin represents a first-in-class oral antifibrotic drug candidate that selectively inhibits Prolyl-tRNA Synthetase (搜索) (PRS (搜索)), 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 compared to existing therapies.
"Bersiporocin represents a breakthrough in antifibrotic therapy by targeting the root cause of fibrosis through PRS (搜索) inhibition," said Seongsoo Park, CEO of Daewoong Pharmaceutical (搜索). "We are committed to advancing this program to help redefine the global IPF (搜索) treatment paradigm."
Diverse Patient Population Enables Ethnic Subgroup Analysis
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 (搜索) patients. Notably, more than half of the enrolled patients are Asian, enabling exploratory assessment of treatment responses across ethnic subgroups. This represents a significant departure from prior IPF studies, which were predominantly limited to White populations.
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.
Trial Design and Progress
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.
"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 (搜索)."
Regulatory Recognition
The drug was granted Orphan Drug Designation by both the U.S. FDA and the European Medicines Agency (搜索) (EMA) in 2019, and has also received Fast Track designation from the FDA, affirming its potential as a globally significant treatment option for IPF (搜索).