Daewoong Pharmaceutical said Berisiporocin, its first-in-class investigational drug for treating idiopathic pulmonary fibrosis (IPF), has passed a key safety milestone in phase 2 clinical trials, bringing it closer to commercialization.

Following a recommendation to continue the trial from the first Independent Data Monitoring Committee (IDMC) meeting held in March, the second IDMC meeting last Friday also endorsed the continuation of the clinical study.

In this latest review, safety data from 59 enrolled patients, including 51 who completed the trial, revealed no significant safety concerns.

The IDMC plans a final safety review at the third meeting scheduled for early next year. The phase 2 trial aims to be completed by 2025.

IPF is a devastating disease characterized by abnormal collagen accumulation in the lungs, leading to loss of lung function. The prognosis for IPF is poor, with a five-year survival rate of just 40 percent. Current treatments only slow fibrosis progression and have high rates of adverse reactions.

Daewoong expects that berisiporocin will demonstrate superior safety and efficacy due to its novel mechanism of directly inhibiting collagen synthesis.

Phase 1 trials confirmed its safety and pharmacokinetics in healthy subjects.

The 24-week phase 2 trial aims to assess the safety, tolerability, and efficacy of Berisiporocin alone and in combination with standard treatments.

The study, launched in Jan of last year in the U.S. and Korea, the trial has enrolled 61 patients, reaching approximately 60 percent of the target 102 participants.

In Korea, the trial is being conducted at ten hospitals, including Asan Medical Center, Severance Hospital, and Samsung Medical Center.

“This IDMC recommendation is a significant milestone proving berisiporocin’s safety in its development journey,” Daewoong Co-CEO Lee Chang-jae said. “We are committed to providing a new treatment option for IPF patients through the innovative drug candidate berisiporocin.”

Berisiporocin was designated an orphan drug by the U.S. FDA in 2019 and received fast track status in 2022. The drug was also designated as an orphan drug by the European Medicines Agency in January of this year.