Policy & Regulation
Daewoong Pharmaceutical presents interim analysis of Bersiporocin Phase 2 trial at ATS 2025
4 June 2025 -

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.

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