Daewoong highlights mid-phase IPF trial progress for PRS-targeting oral drug at ATS 2025

Daewoong Pharmaceutical has presented an interim analysis of its global phase 2 study on bersiporocin (DWN12088), an investigational oral therapy for idiopathic pulmonary fibrosis (IPF), at the American Thoracic Society (ATS) 2025 International Conference.

IPF is a progressive, fatal lung disease characterized by chronic fibrosis of lung tissue, leading to respiratory failure. Despite the availability of current treatments, significant unmet need remains due to limited efficacy and tolerability. Bersiporocin’s differentiated mechanism and promising safety profile generate increasing attention within the global pulmonary community as a possible game-changer in the IPF treatment paradigm.

The poster presentation was featured during the official ATS session, “What’s New in ILD Diagnosis, Monitoring, and Treatment,” held on May 18 in San Francisco, Calif.

Professor Song Jin-woo, a pulmonologist at Asan Medical Center and the trial's global principal investigator, presented the latest data on study enrollment and patient characteristics.

The ongoing trial evaluates the efficacy and safety of bersiporocin, a first-in-class prolyl-tRNA synthetase (PRS) inhibitor, which Daewoong is developing as a next-generation anti-fibrotic drug.

As of April 2025, the multinational phase 2 trial conducted in both the U.S. and Korea had enrolled 79 patients, achieving about 80 percent of its target sample size of 102 participants.

Over half of the enrolled subjects (47 out of 79) are of Asian descent, which contrasts with previous IPF clinical trials that predominantly included white populations. The company said this diversity is expected to enable meaningful analysis of ethnic differences in treatment response.

About 70 percent of patients enrolled in the study receive bersiporocin alongside existing anti-fibrotic standard-of-care therapies such as nintedanib or pirfenidone, while the remaining 30 percent are participating without concomitant medication.

Bersiporocin works by selectively inhibiting PRS, an enzyme involved in collagen synthesis. This novel mechanism is designed to suppress fibrotic progression at its root while minimizing off-target adverse events. Unlike current IPF therapies, which primarily aim to slow disease progression, bersiporocin is positioned as a potential first-in-class treatment that could halt or even reverse fibrosis through a differentiated molecular pathway.

Bersiporocin was originally designated an orphan drug by the U.S. Food and Drug Administration (FDA) in 2019 and granted Fast Track designation in 2022. More recently, in January 2024, the European Medicines Agency (EMA) also awarded the drug orphan status, reinforcing its potential as a globally relevant therapeutic candidate.

“This study is not only a step toward establishing a new therapeutic option but also a valuable opportunity to explore treatment responses across different ethnic populations,” Professor Song said. “We hope bersiporocin will ultimately offer a safer and more effective alternative for IPF patients worldwide.”

Daewoong Pharmaceutical CEO Park Seong-Soo said, “By targeting PRS, bersiporocin offers a fundamentally novel approach to treating pulmonary fibrosis.”

Park added that it has the potential to overcome the limitations of existing therapies, and the company is committed to ensuring this trial contributes meaningfully to the evolving global treatment landscape for IPF.