Home Health Daewoong Pharma Unveils First Patient Data From Phase 2 Trial of Pulmonary...

Daewoong Pharma Unveils First Patient Data From Phase 2 Trial of Pulmonary Fibrosis Drug Bersiporocin

0
Courtesy of Daewoong Pharmaceutical
Courtesy of Daewoong Pharmaceutical

Daewoong Pharmaceutical presented the first full patient-population analysis from its global Phase 2 clinical trial of bersiporocin (DWN12088), an investigational treatment for idiopathic pulmonary fibrosis (IPF), at the 2026 European Respiratory Society (ERS) Congress in Barcelona, Spain.

The presentation covered baseline characteristics of all 104 patients enrolled in the Phase 2 trial in South Korea and the United States.

Idiopathic pulmonary fibrosis is a progressive lung disease in which multiple inflammatory and fibrotic signaling pathways contribute to excessive production and accumulation of collagen. Daewoong’s investigational bersiporocin selectively inhibits prolyl-tRNA synthetase (PRS), a mechanism designed to reduce excessive collagen production associated with the fibrotic process.

The analysis included all IPF patients recruited in South Korea and the United States and evaluated their baseline clinical and functional characteristics. Daewoong had previously disclosed interim enrollment information from the Phase 2 study at the 2025 International Conference of the Korean Academy of Tuberculosis and Respiratory Diseases (KATRDIC). The ERS 2026 presentation marked the first disclosure of the complete patient population.

Of the 104 patients enrolled, 55 patients (52.9%) were from South Korea and 49 (47.1%) were from the United States. A total of 71 patients (68.3%) were receiving existing antifibrotic treatment, while 33 patients (31.7%) were not receiving antifibrotic therapy.

The patients had an average forced vital capacity (FVC) of approximately 77% of the predicted normal value and an average diffusing capacity for carbon monoxide (DLCO) of approximately 51%. Overall baseline characteristics were generally similar between patients receiving existing antifibrotic therapies and those who were not.

FVC measures the amount of air a person can forcibly exhale after taking the deepest possible breath and is a key measure of lung function. DLCO measures how effectively gases such as oxygen move from the lungs into the bloodstream.

The ongoing global Phase 2 trial is being conducted in South Korea and the United States as a randomized, double-blind, placebo-controlled study. Patients receive either bersiporocin or placebo twice daily for 24 weeks. Concomitant treatment with existing antifibrotic drugs pirfenidone or nintedanib is also permitted.

The trial uses stratified randomization based on whether patients are receiving existing antifibrotic treatment. This design is intended to evaluate the efficacy and safety of bersiporocin across a range of treatment settings that reflect real-world clinical practice.

The complete baseline analysis provides important context for interpreting the efficacy and safety results from the Phase 2 trial, which will be disclosed at a later stage. Daewoong is currently working to complete the clinical trial and plans to announce the top-line Phase 2 results in the first half of 2027.

“Sharing the characteristics of the full patient population at ERS 2026 represents an important milestone in the development of bersiporocin,” said Park Sung-soo, CEO of Daewoong Pharmaceutical. “We will secure the top-line Phase 2 results in the first half of 2027 and move forward with subsequent global development and commercialization so that we can accelerate development and provide a new treatment option for IPF patients worldwide.”

NO COMMENTS

LEAVE A REPLY

Please enter your comment!
Please enter your name here

Exit mobile version