Daewoong Pharmaceutical Presents Interim Results of Phase 2 Clinical Trial for "Bercepoforsin"

Global Phase 2 Clinical Trial in the US and Korea
More Than Half of Currently Enrolled Patients Are Asian

Professor Jinwoo Song of the Department of Pulmonology at Asan Medical Center in Seoul (far right) is taking a commemorative photo with officials at the presentation site of the bercepoforsin poster. Photo by Daewoong Pharmaceutical

Daewoong Pharmaceutical announced on June 4 that it presented an interim analysis poster on the global Phase 2 clinical trial design and patient enrollment status for its idiopathic pulmonary fibrosis (IPF) treatment candidate, bercepoforsin (DWN12088), at the "American Thoracic Society (ATS 2025)" held in San Francisco, USA, from May 16 to 21, 2025.

This presentation took place during the official ATS session, "Recent Advances in the Diagnosis, Monitoring, and Treatment of Interstitial Lung Diseases," held on May 18. Professor Jinwoo Song, the principal investigator from the Department of Pulmonology at Asan Medical Center in Seoul, personally delivered the presentation.

According to the interim analysis of enrolled subjects presented at this event, the main characteristics of the patients participating in the clinical trial, including racial composition and concomitant therapy status, were identified.

The global Phase 2 clinical trial of bercepoforsin, currently underway in the United States and Korea, had enrolled 79 patients as of April 2025, which is about 80% of the total target enrollment of 102 patients. Unlike previous IPF clinical trials, which were predominantly conducted with white patients, more than half of the 47 patients in this Phase 2 trial are Asian. This is expected to enable future analyses of differences in treatment response by race.

Additionally, about 70% of all enrolled patients are receiving concomitant antifibrotic agents (nintedanib or pirfenidone), while the remaining 30% are participating in the study without any concomitant medication.

Bercepoforsin is an oral antifibrotic drug candidate independently developed by Daewoong Pharmaceutical. It selectively inhibits the enzyme prolyl-tRNA synthetase (PRS), which is involved in collagen synthesis, thereby fundamentally blocking the progression of fibrosis in lung tissue. This is a novel mechanism distinct from existing therapies, and by acting selectively on the necessary targets, it can reduce the burden of adverse reactions while more effectively inhibiting disease progression. As such, it is attracting attention as a next-generation antifibrotic treatment.

Bercepoforsin was designated as an orphan drug by the U.S. Food and Drug Administration (FDA) in 2019, and in 2022, it was selected for the FDA’s Fast Track development program. In January 2024, it also received orphan drug designation from the European Medicines Agency (EMA), further recognizing its potential as a global new drug.

Professor Jinwoo Song of the Department of Pulmonology at Asan Medical Center in Seoul stated, "This clinical trial not only demonstrates the potential of a new treatment option but is also significant as a study that allows for comparative analysis of responses among various races, including Asians. We hope to provide a safer and more effective therapeutic alternative for patients with idiopathic pulmonary fibrosis."

Park Sungsoo, CEO of Daewoong Pharmaceutical, said, "Bercepoforsin is a new drug with a novel mechanism that blocks the root cause of fibrosis through PRS inhibition and shows the potential to overcome the limitations of existing therapies. We will do our utmost to contribute to the global IPF treatment paradigm through this clinical trial."