Daewoong Pharmaceutical Presents Phase 2 Clinical Trial Poster on 'Bersiporocin' at ATS 2025, Highlights Global Patient Demographics USA - English USA - English
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~ Daewoong Pharmaceutical, led by Co-CEOs Seongsoo Park and Chang-Jae Lee, made a significant announcement at the 2025 American Thoracic Society (ATS) International Conference in San Francisco. The company presented interim results from a global Phase 2 clinical trial of their investigational treatment candidate for idiopathic pulmonary fibrosis (IPF), Bersiporocin (DWN12088).

The presentation was made during the official ATS session titled "WHAT'S NEW IN ILD DIAGNOSIS, MONITORING, AND TREATMENT" on May 18. Dr. Jinwoo Song, Professor of Pulmonology at Asan Medical Center and the trial's global Coordinating Investigator and principal investigator, presented the scientific poster.

The interim analysis highlighted important baseline demographic and clinical characteristics of the enrolled participants. This included information on racial distribution and the use of antifibrotic medication. It was noted that approximately 70% of participants were receiving Bersiporocin in combination with approved antifibrotic therapies such as nintedanib or pirfenidone. The remaining 30% were participating without any background treatment. An interesting aspect of this trial is that more than half of the enrolled patients are Asian, allowing for an exploratory assessment of treatment responses across different ethnic subgroups.

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The ongoing randomized, double-blind, placebo-controlled Phase 2 study is being conducted at 30 sites in the U.S. and South Korea with a target enrollment of 102 IPF patients. Participants receive either 150 mg of Bersiporocin or a placebo twice daily for 24 weeks. The efficacy and safety of the treatment are being assessed based on changes in forced vital capacity (FVC) and other clinical endpoints. As of April 2025, approximately 80% of the target enrollment had been completed with 80 patients registered.

Bersiporocin, developed by Daewoong Pharmaceutical, is a first-in-class oral antifibrotic drug candidate. 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 providing more effective disease control with fewer off-target effects. This positions Bersiporocin as a next-generation therapeutic for IPF.

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The drug has been granted Orphan Drug Designation by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2019. It has also received Fast Track designation from the FDA, highlighting its potential as a globally significant treatment option for IPF.

Professor Jinwoo Song expressed his excitement about the trial, stating that it not only offers hope for a new treatment option but also allows for the assessment of responses across a racially diverse patient population, including Asian patients. He looks forward to providing safer and more effective treatment options for patients with IPF.

CEO of Daewoong Pharmaceutical, Seongsoo Park, added that Bersiporocin represents a breakthrough in antifibrotic therapy by targeting the root cause of fibrosis through PRS inhibition. The company is committed to advancing this program to help redefine the global IPF treatment paradigm.
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