Candidate Drug for Idiopathic Pulmonary Fibrosis Treatment 'Bersiporosin'
Research results on the efficacy and safety of Daewoong Pharmaceutical's idiopathic pulmonary fibrosis treatment candidate 'Versiporosin' have been published in an international academic conference paper.
Daewoong Pharmaceutical announced on the 26th that a study elucidating the molecular mechanism explaining both the efficacy and safety of 'Versiporosin,' under development as a treatment for idiopathic pulmonary fibrosis, has been published in the international SCIE journal 'European Molecular Biology Organization Molecular Medicine.' The paper, co-authored by Professor Kim Seong-hoon of Yonsei University and Professor Hwang Kwang-yeon’s research team at Korea University, is titled 'Control of fibrosis via asymmetric inhibition of prolyl-tRNA synthetase 1 (PARS1)'.
Idiopathic pulmonary fibrosis is an intractable disease characterized by abnormal accumulation of collagen in the lungs, leading to loss of lung function, occurring at a frequency of about 13 cases per 100,000 people worldwide. The prognosis is poor, with a 5-year survival rate of only 40% after diagnosis. However, existing approved treatments have severe side effects, creating a need for new therapeutic agents, according to Daewoong Pharmaceutical.
Versiporosin, developed by Daewoong Pharmaceutical, exerts its therapeutic effect by inhibiting the activity of the PARS1 (Prolyl-tRNA Synthetase 1) enzyme, which promotes collagen synthesis. Although researchers worldwide have attempted to treat pulmonary fibrosis by regulating PRS activity, excessive inhibition of PARS1 enzyme activity can lead to side effects because it is essential for sustaining life, posing challenges in new drug development. Therefore, the key task in drug development was to inhibit PARS1 enzyme activity at a safe level for patients while maintaining therapeutic efficacy.
Through this study, Daewoong Pharmaceutical emphasized that Versiporosin binds asymmetrically to a pair of PARS1 enzymes, avoiding excessive inhibition of activity, thereby demonstrating efficacy while minimizing drug side effects.
PARS1 exists as a dimer of two enzyme units, and its activity promotes collagen synthesis, contributing to the fibrosis process. When Versiporosin is administered, it strongly binds to one enzyme in the PARS1 dimer, inhibiting its activity and alleviating fibrosis. At that moment, the protein structure changes, preventing the other PARS1 enzyme in the dimer from binding to Versiporosin, allowing its activity to be maintained and preserving essential life functions. As a result, fibrosis is alleviated while vital functions are preserved.
Professor Kim Seong-hoon of Yonsei University, the corresponding author of this study, stated, "To realize precision medicine and secure global-level new drug development capabilities, discovering new mechanism-based drug targets is urgently needed." He added, "This study is significant in proving that essential enzymes like PARS1 can also be utilized as targets for new drug development."
Park Joon-seok, head of Daewoong Pharmaceutical's New Drug Discovery Center, said, "Versiporosin, the world's first innovative new drug independently developed by Daewoong Pharmaceutical, has secured important research results explaining its efficacy and safety through this study." He added, "Based on this, we hope to rapidly proceed with the ongoing Phase 2 clinical trials to provide new treatment options for patients suffering from rare diseases."
Versiporosin was designated as an orphan drug by the U.S. Food and Drug Administration (FDA) last year and was the first in Korea to be designated as an FDA Fast Track product. It was also selected as a project supported by the Korea Drug Development Fund (KDDF) for national new drug development, receiving research funding for clinical trials.
Meanwhile, in January, Daewoong Pharmaceutical signed a technology export contract for Versiporosin in the Greater China region with CS Pharmaceuticals, based in the United Kingdom. The contract is valued at approximately 413 billion KRW.
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