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Daewoong Pharmaceutical Unveils Promising Phase 2 Trial Results for Bersiporocin at ATS 2025

In an exciting development for the treatment of idiopathic pulmonary fibrosis (IPF), Daewoong Pharmaceutical, spearheaded by Co-CEOs Seongsoo Park and Chang-Jae Lee, presented interim findings from its global Phase 2 clinical trial for Bersiporocin (DWN12088) at the 2025 American Thoracic Society (ATS) International Conference held from May 16 to 21 in San Francisco.

Innovative Approach to IPF Treatment

The Phase 2 clinical trial, which aims to evaluate the efficacy and safety of Bersiporocin, is currently enrolling participants across 30 sites in the U.S. and South Korea. The trial's design is noteworthy, as it targets a diverse demographic, with over 50% of the 102 enrolled patients identified as Asian. This diversity allows for a nuanced understanding of the treatment's effects across various ethnic backgrounds.

Presented on May 18, the scientific poster was showcased during the session entitled WHAT’S NEW IN ILD DIAGNOSIS, MONITORING, AND TREATMENT, led by Dr. Jinwoo Song, a prominent professor of pulmonology at Asan Medical Center and the trial's global coordinating investigator.

Study Details and Participant Demographics

The interim results highlighted the baseline characteristics of the enrolled participants. Of these, approximately 70% received Bersiporocin in conjunction with approved antifibrotic therapies such as nintedanib or pirfenidone, while the remainder engaged in the trial without any background treatment. This combination therapy approach affirms Daewoong's commitment to improving treatment outcomes for patients with IPF, particularly those who may not have responded well to existing therapies.

By targeting a racial mix that includes a significant proportion of Asian patients, this study marks a shift from earlier IPF trials that primarily involved White populations. This inclusive approach is crucial as it enables a thorough exploratory assessment of treatment responses within different ethnic subgroups.

Mechanism of Action and Safety Profile

Bersiporocin is a first-in-class oral antifibrotic drug that selectively inhibits Prolyl-tRNA Synthetase (PRS), a vital enzyme in collagen synthesis and proline activation. By blocking PRS, the drug aims to interrupt the fibrotic process, potentially offering more effective disease control and reducing unwanted off-target effects associated with other treatments.

The study involves participants taking either 150 mg of Bersiporocin or a placebo twice daily over a 24-week period, assessing efficacy through changes in forced vital capacity (FVC) and other relevant clinical endpoints. As of April 2025, around 80% of the target enrollment had been achieved, providing an optimistic outlook for the trial's progression.

Recognition and Future Outlook

In recognition of its potential, Bersiporocin has received Orphan Drug Designation from both the U.S. FDA and the European Medicines Agency (EMA) in 2019, along with Fast Track designation from the FDA. These recognitions underscore the drug's promise as a significant treatment option for IPF on a global scale.

Reflecting on the trial's importance, Professor Jinwoo Song stated, “This trial not only offers hope for a new treatment option, but also allows us to assess responses across a racially diverse patient population, including Asian patients.” Both he and Seongsoo Park conveyed their enthusiasm for continuing to develop Bersiporocin as a breakthrough therapy in antifibrotic treatments, reaffirming their commitment to improving the lives of patients suffering from IPF.

As the trial progresses, the pharmaceutical community eagerly awaits more data on Bersiporocin’s efficacy and safety in this diverse patient population. The findings from this Phase 2 clinical trial hold potential implications that could reshape the future of IPF treatment strategies around the world.