Daewoong Pharmaceutical Receives Positive Recommendation from IDMC to Continue Developing its First-in-Class PRS Inhibitor, Bersiporocin

SEOUL, South Korea, July 29, 2024 /PRNewswire/ -- Daewoong Pharmaceutical (Co-CEOs Chang-Jae Lee and Seongsoo Park) announced a significant milestone in the development of 'Bersiporocin (DWN12088)', a first-in-class PRS inhibitor for idiopathic pulmonary fibrosis (IPF), has taken a significant step towards commercialization by demonstrating positive safety data from the Phase 2 clinical trial.

Following the initial Independent Data Monitoring Committee (IDMC) meeting held in March, the second meeting on July 26 also recommended the continuation of the clinical trial without modification. This latest IDMC meeting involved an in-depth review of the safety data of Bersiporocin, covering 59 enrolled patients, including 51 patients who completed the IPF clinical trial, and found no significant issues.

The IDMC is set to conduct a final safety review of the Phase 2 trial in a third meeting scheduled for early next year. Completion of the Phase 2 trial is anticipated by 2025.

Idiopathic Pulmonary Fibrosis (IPF) is a rare and fatal disease characterized by abnormal collagen accumulation in the lungs, leading to loss of lung function. The prognosis is poor, with a 5-year survival rate of only 40% after diagnosis, and current treatments merely slow the progression of fibrosis, offering limited efficacy with high rates of adverse reactions, underscoring the urgency for new drug development.

Bersiporocin is expected to demonstrate differentiated safety and efficacy through a novel mechanism that directly inhibits PRS (Prolyl-tRNA Synthetase), targeting the excess collagen production that leads to fibrosis. Phase 1 trials confirmed its safety and pharmacokinetic properties in healthy individuals. The ongoing Phase 2 trial targets IPF patients aged 40 and above, including those currently on background therapy.

The 24-week trial assesses the safety, tolerability, and efficacy of Bersiporocin both as a monotherapy and in combination with existing treatments. Initiated in January 2023 in the US and Korea, the trial has so far enrolled 61 patients, achieving about 60% of the target 102 patients. Chang-jae Lee, Co-CEO of Daewoong Pharmaceutical, stated, "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."

Additionally, Bersiporocin has received orphan drug designation by the US FDA in 2019 as well as EMA in 2024, and fast track designation in 2022. In 2023, Daewoong signed an exclusive licensing agreement with CS Pharmaceuticals for the Greater China region, accelerating its entry into the global market.

Forward-Looking Statements

This press release contains forward-looking statements that are based on the current beliefs and expectations of Daewoong Pharmaceutical's management. Factors that could cause or contribute to such differences include, but are not limited to: (1) Regulatory and governmental approvals: The approval process for pharmaceutical products is subject to extensive regulations and may involve uncertainties and delays. Any failure to obtain necessary approvals or the occurrence of delays in the approval process could adversely affect Daewoong Pharmaceutical's business and results of operations; and (2) Clinical trials: The success of Daewoong Pharmaceutical's products depends on the results of clinical trials. The results of early clinical trials may not be indicative of the results of later-stage or larger-scale clinical trials.