#South Korea #Seoul #IPF Treatment #Bersiporocin #Daewoong Pharmaceutical

Daewoong Pharmaceutical Unveils Phase 2 Trial Data on Bersiporocin at ATS 2025

In an exciting presentation at the 2025 American Thoracic Society (ATS) International Conference, Daewoong Pharmaceutical shared interim findings from its groundbreaking Phase 2 clinical trial of Bersiporocin, a novel treatment under investigation for idiopathic pulmonary fibrosis (IPF). The meeting, held from May 16 to 21 in San Francisco, served as a platform to showcase the global diversity of patients involved in the trial and their initial responses to the treatment.

The Study Overview

The ongoing clinical trial is set to enroll a total of 102 participants across 30 sites in both the U.S. and South Korea. More than 50% of the participants thus far have been identified as Asian, marking a significant shift from previous studies primarily featuring White populations. This demographic diversity is essential, as it allows researchers to evaluate the efficacy of Bersiporocin in various racial subgroups.

Dr. Jinwoo Song, Professor of Pulmonology at Asan Medical Center and the principal investigator of the trial, presented the findings during the ATS session titled “What's New in ILD Diagnosis, Monitoring, and Treatment”. His analysis focused on the baseline characteristics of trial participants, including their racial backgrounds and concurrent use of antifibrotic medications.

Among the participants, approximately 70% were undergoing treatment with Bersiporocin in conjunction with established antifibrotic therapies like nintedanib or pirfenidone. The remaining 30% received the medication without any background treatment, allowing for a comprehensive assessment of the drug's efficacy in different contexts.

Mechanism of Action

Bersiporocin represents a first-in-class oral antifibrotic, specifically designed to selectively inhibit Prolyl-tRNA Synthetase (PRS), an enzyme vital for collagen biosynthesis. This innovative approach aims to target the fibrotic process at its inception, potentially leading to superior disease control with fewer adverse side effects compared to traditional therapies. The goal is to redefine the treatment landscape for IPF by providing more efficient and safer options for patients.

This investigational drug has received Orphan Drug Designation by both the U.S. FDA and the European Medicines Agency (EMA), also earning Fast Track designation from the FDA, signaling its potential as a crucial treatment option for those afflicted by IPF.

Response from Leadership

Seongsoo Park, co-CEO of Daewoong Pharmaceutical, expressed optimism regarding the trial's implications for patients. He stated, “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.”

In a similar sentiment, Dr. Song emphasized the importance of assessing treatment responses across diverse racial backgrounds, stating, “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.”

Next Steps

The trial is designed as a randomized, double-blind, placebo-controlled study over a period of 24 weeks. Participants receive either 150 mg of Bersiporocin or a placebo, with effectiveness and safety evaluated through various clinical endpoints such as changes in forced vital capacity (FVC). As of April 2025, significant progress has already been made, with 80 patients (around 80% of the enrollment target) completing registration for the study.

As research continues, the world will be watching closely to see if Bersiporocin can emerge as a leading treatment option in the management of idiopathic pulmonary fibrosis, potentially bringing hope to thousands of patients affected by this challenging condition.