- Third Independent Data Monitoring Committee (IDMC) review confirms safety and continuation of the study
- 94 patients enrolled out of 102 planned across Korea and the U.S.
- Interim baseline characteristics to be presented at the 2025 KATRD International Conference
SEOUL, South Korea, Oct. 27, 2025 /PRNewswire/ -- Daewoong Pharmaceutical (Co-CEOs Seong-Soo Park and Chang-Jae Lee) announced that its first-in-class idiopathic pulmonary fibrosis (IPF) drug candidate Bersiporocin (DWN12088) received a recommendation to continue its global Phase 2 clinical trial following a positive safety review by the third Independent Data Monitoring Committee (IDMC) held on September 23.
The IDMC conducted an in-depth evaluation of interim safety data from 89 enrolled patients and found no significant safety concerns that would impact the trial's continuation. To date, Daewoong has enrolled 94 participants, representing approximately 92% of the target population (102 patients), and the study is progressing as planned.
The ongoing Phase 2 trial (ClinicalTrials.gov Identifier: NCT05389215) aims to evaluate the safety, tolerability, and efficacy of Bersiporocin as monotherapy or in combination with approved antifibrotic drugs (nintedanib or pirfenidone) in patients aged 40 years and older.
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive lung disease characterized by abnormal collagen accumulation leading to irreversible loss of lung function. Currently available treatments can only slow disease progression, highlighting the unmet medical need for novel therapies that address the root cause of fibrosis.
Bersiporocin is a first-in-class, orally administered antifibrotic therapy that selectively inhibits prolyl-tRNA synthetase (PRS) - a key enzyme involved in collagen synthesis. By directly blocking this pathway, Bersiporocin is designed to halt fibrosis at its origin, potentially overcoming the limitations of existing antifibrotic treatments. The trial is being conducted at major clinical sites in South Korea and the United States. Trial information is available at ClinicalTrials.gov (NCT05389215) and the Pulmonary Fibrosis Foundation (PFF) clinical registry.
Professor Jin Woo Song of Asan Medical Center, who serves as the Coordinating Investigator and Principal Investigator of the global Phase 2 study, will present on October 30 a poster at the 2025 KATRD International Conference (Korean Academy of Tuberculosis and Respiratory Diseases, October 29-31) featuring the interim analysis of baseline characteristics from 92 enrolled patients. The findings demonstrate consistency in key demographic and functional characteristics and treatment patterns between Korean and U.S. cohorts, supporting the applicability of the trial design across diverse populations and providing a foundation for interpreting future efficacy outcomes.
"This third IDMC recommendation represents a major milestone reaffirming the safety and progress of Bersiporocin," said Seong-Soo Park, CEO of Daewoong Pharmaceutical. "We will continue to advance the Phase 2 study to deliver a new and effective treatment option for patients suffering from idiopathic pulmonary fibrosis worldwide."
SOURCE Daewoong Pharmaceutical Co., Ltd.
