Barcelona – September 24, 2026 -- Daewoong Pharmaceutical has completed enrollment of 104 idiopathic pulmonary fibrosis (IPF) patients in its global Phase 2 trial of Bersiporocin (DWN12088), with top-line results now expected in the first half of 2027.
Trial spans South Korea and the US with balanced enrollment
Of the 104 patients, 55 (52.9%) were enrolled in South Korea and 49 (47.1%) in the United States. The company presented full baseline patient characteristics at the European Respiratory Society (ERS) Congress 2026 in Barcelona on September 6, following interim data shared earlier at KATRDIC 2025.
Trial design mirrors real-world treatment patterns
A total of 71 patients (68.3%) were receiving background antifibrotic therapy at enrollment, while 33 patients (31.7%) were not. Mean forced vital capacity (FVC) across the cohort was approximately 77% predicted, and mean diffusing capacity for carbon monoxide (DLCO) was approximately 51% predicted, with baseline profiles broadly similar between the two treatment subgroups.
Randomized trial tests twice-daily dosing over 24 weeks
The double-blind, placebo-controlled study allows concomitant use of pirfenidone or nintedanib, the two approved antifibrotics for IPF, alongside Bersiporocin or placebo dosed twice daily. This design lets Daewoong assess efficacy and safety both as monotherapy and as an add-on to existing standard-of-care regimens.
Novel PRS-inhibitor mechanism targets collagen synthesis directly
Bersiporocin selectively inhibits prolyl-tRNA synthetase (PRS), acting downstream of multiple profibrotic signaling pathways to reduce excess collagen production, a mechanism distinct from currently marketed IPF therapies.
Regulatory designations from FDA and EMA back the program
The drug candidate holds Orphan Drug Designation and Fast Track status from the US FDA, plus Orphan Drug Designation from the European Medicines Agency.
Professor Moo Suk Park of Severance Hospital's Department of Pulmonology, an investigator on the study, said the baseline dataset offers a comprehensive profile of enrolled patients that will help contextualize forthcoming efficacy and safety readouts. Daewoong Co-CEO Seongsoo Park called the completed enrollment and baseline data presentation a "significant milestone" in the program's development, with the company now moving toward the H1 2027 top-line data release to guide subsequent global development plans.