South Korea-based Daewoong Pharmaceutical announced on Tuesday that it has presented interim results from a global Phase 2 clinical trial of its investigational idiopathic pulmonary fibrosis (IPF) treatment candidate Bersiporocin (DWN12088) at the 2025 American Thoracic Society (ATS) International Conference, held from 16 to 21 May in San Francisco.
The interim analysis highlighted key baseline demographic and clinical characteristics of enrolled participants, including racial distribution and antifibrotic medication use.
The ongoing randomised, double-blind, placebo-controlled Phase 2 study is being conducted at 30 sites in the US and South Korea, involving 102 IPF patients. Participants receive 150 mg of Bersiporocin or placebo twice daily for 24 weeks, with efficacy and safety assessed based on changes in forced vital capacity (FVC) and other clinical endpoints. As of April 2025, 80 patients (approximately 80% of target enrolment) had completed registration.
Bersiporocin is a first-in-class oral antifibrotic drug candidate developed by Daewoong Pharmaceutical. It selectively inhibits Prolyl-tRNA Synthetase (PRS), a key enzyme in proline activation and collagen biosynthesis. This targeted mechanism aims to interrupt the fibrotic cascade at its origin, potentially delivering more effective disease control with fewer off-target effects.
The drug was granted Orphan Drug Designation by both the US FDA and the European Medicines Agency (EMA) in 2019, and has also received Fast Track designation from the FDA -- affirming its potential as a globally significant treatment option for IPF.
Relay Therapeutics wins FDA breakthrough status for zovegalisib in breast cancer treatment
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Lupin launches Dasatinib tablets in US market
WuXi Biologics enters into licence and research service agreement with Vertex Pharmaceuticals
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Ascletis Pharma Inc reports topline results from Phase III open-label study of denifanstat
Innovative Molecules GmbH completes Phase 1 clinical development programme for adibelivir
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA