Daewoong's First-in-Class IPF Drug Bersiporocin Clears Third Safety Review, Phase 2 Trial Nears Completion

Key Insights

• Daewoong Pharmaceutical's Bersiporocin received a positive safety recommendation from the third Independent Data Monitoring Committee review, allowing continuation of the global Phase 2 clinical trial for idiopathic pulmonary fibrosis.
• The trial has enrolled 94 out of 102 planned patients across Korea and the U.S., representing 92% completion of the target enrollment.
• Bersiporocin represents a first-in-class approach by selectively inhibiting prolyl-tRNA synthetase, targeting the root cause of fibrosis rather than just slowing disease progression.

Daewoong Pharmaceutical 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.

Trial Progress and Enrollment

To date, Daewoong has enrolled 94 participants, representing approximately 92% of the target population of 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.

The trial is being conducted at major clinical sites in South Korea and the United States, with trial information available at ClinicalTrials.gov and the Pulmonary Fibrosis Foundation clinical registry.

Novel Mechanism of Action

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.

This mechanism represents a significant departure from current therapeutic approaches. Idiopathic pulmonary fibrosis 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.

Clinical Data Presentation

Professor Jin Woo Song of Asan Medical Center, who serves as the Coordinating Investigator and Principal Investigator of the global Phase 2 study, presented a poster on October 30 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.

Company Leadership Perspective

"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."

The positive safety review marks a critical milestone for Daewoong Pharmaceutical as the company advances its novel approach to treating IPF, a condition with significant unmet medical needs and limited therapeutic options that address the underlying pathophysiology of the disease.