#South Korea #Seoul #Bersiporocin #Daewoong Pharma #IPF Research

Daewoong Pharmaceutical’s Clinical Advancements with Bersiporocin

Daewoong Pharmaceutical, under the leadership of Co-CEOs Seong-Soo Park and Chang-Jae Lee, recently released promising news regarding its investigational drug, Bersiporocin (DWN12088). This novel therapeutic candidate targeting idiopathic pulmonary fibrosis (IPF) has received support for the continuation of its global Phase 2 clinical trials following a comprehensive safety review conducted by the Independent Data Monitoring Committee (IDMC). The review, which took place on September 23, confirmed that the trial could safely progress without any significant safety issues threatening its validity.

Safety Review Highlights

The IDMC meticulously assessed data from 89 patients enrolled in the trial, and demonstrated that no major safety concerns emerged, inspiring confidence in Bersiporocin's further development. Currently, a total of 94 patients have participated, which corresponds to approximately 92% of the planned 102 patient cohort. With the study making progress as expected, Daewoong looks forward to accomplishing its objectives in this phase of evaluation.

Purpose of the Phase 2 Trial

The ongoing Phase 2 trial, registered on ClinicalTrials.gov (NCT05389215), seeks to establish the safety, tolerability, and efficacy of Bersiporocin either as a standalone treatment or in combination with existing antifibrotic agents such as nintedanib or pirfenidone. This dual approach amplifies the potential benefits for patients aged 40 and above who are battling this debilitating disease.

Idiopathic pulmonary fibrosis is a chronic, progressive lung condition notorious for its gradual destruction of lung function due to excess collagen accumulation. This poses a dire need for innovative treatment options that not only suppress symptoms but also address the underlying fibrosis processes.

Bersiporocin’s Unique Mechanism

What differentiates Bersiporocin from other treatments is its mechanism: this first-in-class drug selectively inhibits prolyl-tRNA synthetase (PRS), a critical enzyme involved in collagen production. By blocking this pathway, Bersiporocin aims to address fibrosis directly at its root, providing new hope for patients who have exhausted existing therapies that only manage symptoms instead of providing lasting relief.

Global Clinical Trial Sites

The Phase 2 study is being conducted at several key clinical sites in both South Korea and the United States. This international focus enhances the robustness of the trial and broadens patient demographics for a richer data set. Insights gained during the trial will help shape future research and treatment approaches for IPF.

Upcoming Presentations

On October 30, Professor Jin Woo Song from Asan Medical Center, who serves as the Coordinating Investigator, will unveil findings from an interim analysis at the 2025 KATRD International Conference. This analysis will present baseline characteristics from 92 enrolled patients, demonstrating consistency across key demographic and functional traits in both Korean and American participant groups. Such findings will facilitate a better understanding of the treatment's applicability across diverse populations and will aid in interpreting clinical outcomes moving forward.

Conclusion: A Milestone for Daewoong

The recent IDMC endorsement signifies an important milestone for Daewoong Pharmaceutical, reaffirming the safety and progress associated with Bersiporocin. As noted by CEO Seong-Soo Park, the company is committed to advancing the Phase 2 study with the goal of delivering a novel and effective treatment option for patients suffering from idiopathic pulmonary fibrosis worldwide. This development not only marks a significant step forward for Daewoong, but potentially for the future of IPF treatment as a whole, filling a critical gap in the current therapeutic landscape.