IDMC Recommends Daewoong Continue Developing PRS Inhibitor Bersiporocin

Daewoong Pharmaceutical, headquartered in Seoul, South Korea, has announced a significant development in the journey towards the commercialization of 'Bersiporocin (DWN12088)', a groundbreaking PRS inhibitor designed for treating idiopathic pulmonary fibrosis (IPF). This announcement follows promising safety data results from the ongoing Phase 2 clinical trial.

After a thorough review during the Independent Data Monitoring Committee (IDMC) meeting held on July 26, the committee recommended continuing the trial without any modifications. This assessment encompassed safety data from 59 patients enrolled in the trial, including 51 who had completed the study. The IDMC had previously met in March and endorsed the continuation of the trial. A final safety review is scheduled for early next year, with the completion of the Phase 2 trial anticipated by 2025.

Idiopathic Pulmonary Fibrosis (IPF) is a rare, life-threatening condition marked by abnormal collagen accumulation in the lungs, leading to diminished lung function. The prognosis for IPF patients is grim, with only a 40% survival rate five years post-diagnosis. Current treatments for IPF primarily aim to slow the progression of fibrosis, but they offer limited benefits and often come with significant adverse effects. This scenario underscores the critical need for new and more effective treatment options.

Bersiporocin represents a novel therapeutic approach that directly inhibits PRS (Prolyl-tRNA Synthetase), targeting the excessive collagen production that characterizes IPF. Phase 1 trials had previously established the safety and pharmacokinetic properties of Bersiporocin in healthy individuals. The ongoing Phase 2 trial is focused on IPF patients aged 40 and above, including those already receiving other therapies.

The 24-week clinical trial, initiated in January 2023 across the United States and Korea, evaluates the safety, tolerability, and efficacy of Bersiporocin both as a monotherapy and in conjunction with existing treatments. To date, 61 patients have been enrolled, achieving approximately 60% of the targeted 102 patients. Daewoong Pharmaceutical’s Co-CEO, Chang-jae Lee, emphasized the importance of the IDMC's recommendation, stating, "The IDMC's recommendation is a crucial milestone in proving the safety of Bersiporocin for its smooth development. We will continue to strive to provide new treatment options for IPF patients through the development of this innovative new drug candidate."

Bersiporocin has also achieved several significant regulatory milestones. It was granted orphan drug designation by the US FDA in 2019 and by the EMA in 2024. Additionally, it received fast track designation from the FDA in 2022. These designations are intended to facilitate the development and expedite the review of drugs that treat serious conditions and address unmet medical needs. In 2023, Daewoong Pharmaceutical further expanded its reach by signing an exclusive licensing agreement with CS Pharmaceuticals, paving the way for Bersiporocin’s entry into the Greater China market.

Overall, these advancements signify a promising horizon for IPF patients, offering hope for more effective and safer treatment options through the innovative mechanism of Bersiporocin.