Daewoong Pharmaceutical's IPF Drug Development Progresses Smoothly... Safety Reconfirmed by Third IDMC

Recommendation to Continue Bersiporocin Clinical Trial
Interim Analysis to Be Presented at KATRD International Conference on October 30

Daewoong Pharmaceutical announced on October 27 that its idiopathic pulmonary fibrosis (IPF) treatment, Bersiporocin (DWN12088), which is being developed as a first-in-class drug, has once again received confirmation of safety and a recommendation to continue the clinical trial from the third Independent Data Monitoring Committee (IDMC) during Phase 2 clinical trials (NCT05389215).

At the third IDMC meeting held on September 23, interim safety data, including 89 enrolled patients, were thoroughly reviewed, and no significant adverse findings that could affect the continuation of the clinical trial were identified. Accordingly, Daewoong Pharmaceutical is proceeding with the Phase 2 clinical trial of Bersiporocin as planned and has completed enrollment of 94 patients, which accounts for approximately 92% of the total target of 102 participants.

Idiopathic pulmonary fibrosis is a rare disease characterized by progressive fibrosis of the lungs, leading to decreased respiratory function. Currently approved treatments only slow the progression of the disease and offer limited fundamental therapeutic effects. As a result, there is a growing need to develop new drugs with novel mechanisms to overcome the limitations of existing treatments.

Bersiporocin is a treatment with a novel mechanism that selectively inhibits Prolyl-tRNA Synthetase (PRS), a key enzyme in collagen synthesis, thereby blocking the root cause of fibrosis. The ongoing Phase 2 clinical trial is evaluating the safety, tolerability, and efficacy of Bersiporocin, either as a monotherapy or in combination with existing treatments (nintedanib, pirfenidone), in IPF patients aged 40 and older.

This clinical trial is being conducted simultaneously at major research institutions in Korea and the United States. In Korea, 10 institutions are participating, including Asan Medical Center, Severance Hospital, Samsung Medical Center, Soonchunhyang University Bucheon Hospital, Bucheon St. Mary's Hospital, Ajou University Hospital, Myongji Hospital, Ulsan University Hospital, and Inje University Busan Paik Hospital.

On October 30, at the KATRD International Conference 2025, Jinwoo Song, Professor of Pulmonology at Asan Medical Center and principal investigator of the clinical trial, is scheduled to present the interim analysis results of 92 enrolled patients in a poster session. The presentation will reveal key demographic and functional characteristics, the proportion of combination therapy, and other clinical features of patient groups enrolled in Korea and the United States. These results are expected to serve as important evidence for assessing the clinical significance of Bersiporocin and the treatment response characteristics by ethnicity.

Park Sungsoo, CEO of Daewoong Pharmaceutical, stated, "The results from the third IDMC meeting are an important milestone confirming the safety of Bersiporocin. We will proceed with Phase 2 clinical trials without delay to provide a new treatment option for patients with idiopathic pulmonary fibrosis."

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