Daewoong Pharmaceutical announced on October 27 that their investigational drug ‘Verceporosin (DWN12088)’, a first-in-class treatment for idiopathic pulmonary fibrosis (IPF), has received reaffirmation of safety and continued trial recommendation from the third independent Data Monitoring Committee (IDMC) during Phase 2 clinical trials (NCT05389215).
During the third IDMC review held on September 23, comprehensive analysis of interim safety data involving 89 enrolled patients revealed no serious adverse findings that would impact the continuation of the trial. Accordingly, Daewoong is proceeding with the Phase 2 study as planned, having enrolled approximately 94 out of the total target of 102 patients, accounting for about 92% of the recruitment goal.
IPF is a rare disease characterized by progressive lung fibrosis, leading to declining respiratory function. Currently approved treatments only slow disease progression and have limited curative effects, highlighting the urgent need for novel therapies with different mechanisms of action.
Verceporosin works by selectively inhibiting Prolyl-tRNA Synthetase (PRS), a key enzyme in collagen synthesis, thereby targeting the fundamental cause of fibrosis. The ongoing Phase 2 trial is evaluating the safety, tolerability, and efficacy of Verceporosin administered alone or in combination with existing drugs such as nintedanib and pirfenidone in patients over 40 years old with IPF.
The trial is being conducted simultaneously at major research hospitals in Korea and the United States, including Seoul Asan Medical Center, Yonsei Shinchon Severance Hospital, Samsung Medical Center, Soonchunhyang Buchen Hospital, Bucheon St. Mary’s Hospital, Ajou University Hospital, Myeongji Hospital, Ulsan University Hospital, and Inje University Busan Paik Hospital.
Additionally, on October 30, Professor Jinu Song of Seoul Asan’s Pulmonology Department, the principal investigator, will present interim characteristics analysis results of 92 enrolled patients at the upcoming KATRD International Conference 2025. This presentation will disclose demographic, functional, and combination therapy data between Korean and US patient groups, providing crucial insights into the clinical relevance and racial response variability of Verceporosin.
Daewoong CEO Paksungsoo stated, “The third IDMC’s safety reaffirmation is a significant milestone,” adding, “We will continue to advance our Phase 2 trial without setbacks to offer a new therapeutic option for IPF patients.”
