Daewoong Presents Baseline Data for All 104 Patients in Global Phase 2 IPF Trial of Bersiporocin
核心洞察
Daewoong Pharmaceutical (搜索) reported baseline clinical and functional characteristics for all 104 idiopathic pulmonary fibrosis (搜索) patients enrolled in the global Phase 2 trial of Bersiporocin (DWN12088).
Enrollment comprised 55 patients (52.9%) from South Korea and 49 (47.1%) from the United States, with 71 patients (68.3%) on background antifibrotic therapy and 33 (31.7%) untreated.
Mean forced vital capacity was approximately 77% predicted and mean DLCO approximately 51% predicted, with baseline characteristics generally similar between antifibrotic-treated and untreated groups.
Daewoong Pharmaceutical (搜索) presented a poster at the European Respiratory Society (ERS) Congress 2026 detailing the baseline clinical and functional characteristics of all 104 patients enrolled in the global Phase 2 trial of its idiopathic pulmonary fibrosis (搜索) (IPF) drug candidate Bersiporocin (DWN12088). The presentation took place on September 6 in Barcelona, Spain, and marked the first time the company disclosed baseline data from the fully enrolled study population, following interim enrollment data presented at KATRDIC 2025.
Enrollment and Baseline Profile
The analysis covered all IPF patients recruited in South Korea and the United States. Of the 104 patients, 55 (52.9%) were enrolled in South Korea and 49 (47.1%) in the US. A total of 71 patients (68.3%) were receiving background antifibrotic therapy, while 33 patients (31.7%) were not.
Mean forced vital capacity (FVC) was approximately 77% predicted, and mean diffusing capacity of the lungs for carbon monoxide (DLCO) was approximately 51% predicted. Baseline clinical and functional characteristics were generally similar between patients with and without background antifibrotic therapy.
Mechanism and Trial Design
IPF is a disease in which various inflammatory and fibrotic signals interact, leading to excessive production and accumulation of collagen. Bersiporocin selectively inhibits prolyl-tRNA synthetase (搜索) (PRS), reducing excessive collagen production associated with fibrosis. According to Daewoong, the candidate has a differentiated mechanism of action that targets collagen synthesis downstream of multiple profibrotic signals through PRS inhibition. Based on this mechanism, it is being evaluated both in patients receiving background antifibrotic therapy and in those not receiving such treatment.
The ongoing global Phase 2 study is a randomized, double-blind, placebo-controlled trial conducted in South Korea and the US. Patients receive either Bersiporocin or placebo twice daily for 24 weeks, with concomitant use of pirfenidone or nintedanib permitted. The design reflects real-world IPF treatment settings by including patients both with and without background antifibrotic therapy.
Regulatory Status and Next Steps
Bersiporocin holds Orphan Drug Designation and Fast Track status from the US Food and Drug Administration (搜索), as well as Orphan Drug Designation from the European Medicines Agency (搜索).
Daewoong said the baseline analysis provides context for interpreting the Phase 2 efficacy and safety results, which the company plans to announce in the first half of 2027.
Professor Moo Suk Park of the Department of Pulmonology at Severance Hospital, who participated in the study, said the work "provides a comprehensive overview of the baseline characteristics of 104 IPF patients enrolled in South Korea and the US," adding that because the study includes patients both with and without background antifibrotic therapy, the baseline data "will provide important context for interpreting the efficacy and safety outcomes of Bersiporocin."
Seongsoo Park, CEO of Daewoong Pharmaceutical (搜索), described the completion of enrollment and the presentation of the full baseline patient profile at ERS 2026 as a significant milestone in the candidate's development. He said the company will continue to advance the program toward top-line Phase 2 results in the first half of 2027 and use the findings to inform subsequent global development.