▲Daewoong Pharmaceutical Clinical Development Center Director Lee Ji-seon (left) is taking a commemorative photo with KDDF Director Muk Hyeon-sang
【Health and Welfare News】Daewoong Pharmaceutical (CEO Seung-ho Jeon and Chang-jae Lee) announced that its clinical research for ‘Versiporocin (DWN12088)’ was selected as one of the top 10 excellent projects of the 2023 National New Drug Development Project (hereinafter referred to as High Performance) by the Korea New Drug Development Foundation (KDDF, Director Mook Hyun-sang). It was announced on the 19th that it was selected as an excellent project.
Verciporosin, a new drug for idiopathic pulmonary fibrosis that Daewoong Pharmaceutical is developing as the world’s first new drug (first-in-class), was selected as a ‘new drug clinical development support’ project by KDDF’s national new drug development industry in September last year.
High Performance is awarded to tasks that have achieved excellent results, such as achieving technology transfer results or achieving target milestones early. Versiphorocin’s technology was exported to Greater China earlier this year.
The awards ceremony was held at the Dragon City Hotel in Seoul on the 12th, and in the accompanying presentation, Daewoong Pharmaceutical Clinical Development Center Director Lee Ji-seon was the speaker and presented Versiphorosin (DWN12088), which is being developed as the world’s first new drug for idiopathic pulmonary fibrosis (IPF). A presentation was held on the development background, global competitiveness and performance of .
Director Lee said, “We plan to complete a phase 2 clinical study evaluating safety and efficacy on a total of 102 idiopathic pulmonary fibrosis patients within 2025. “Daewoong Pharmaceutical aims to improve the competitiveness of versiporosin through expansion of indications other than pulmonary fibrosis and global technology transfer,” he said, expressing confidence in the clinical status and future plans of versiporosin.
Versiporosin is the world’s first PRS (Prolyl-tRNA Synthetase) inhibitory anti-fibrotic drug being developed by Daewoong Pharmaceutical with its own technology. It has a mechanism to suppress excessive production of collagen, which causes fibrosis, by reducing the action of PRS protein, which affects collagen production. In particular, a paper published by the European Society for Molecular Biology (EMBO) last May showed that versiporosin can alleviate fibrosis to the extent that essential functions for the patient’s life are maintained through selective binding to the paired PRS enzyme. explained. In other words, it was found that the side effects of the drug can be minimized and both efficacy and safety can be satisfied.
The safety and pharmacokinetic properties of versiporosin were confirmed in a total of 162 healthy subjects in multiple phase 1 clinical trials conducted in Korea and Australia, and a multinational phase 2 clinical trial is currently underway in Korea and the United States.
In addition, versiporosin has been designated as an orphan drug and a fast-track development item by the U.S. FDA. For drugs designated as FDA fast track, close consultation with the FDA is possible during the approval process, including consultation on clinical design and advice on obtained data at each stage of development.
Seung-ho Jeon, CEO of Daewoong Pharmaceutical, said, “We are pleased that the world’s first PRS-inhibiting anti-fibrotic drug versiporosin, which is being developed by Daewoong Pharmaceutical with its own technology, has been recognized by the National New Drug Development Corporation for its competitiveness and commercialization potential, and is entering the global idiopathic pulmonary fibrosis treatment market. “We will further accelerate development so that we can advance quickly and provide treatment options to patients with rare diseases.”
Meanwhile, according to global market research firm Research And Markets, the idiopathic pulmonary fibrosis treatment market is expected to grow at a high rate of 8% annually and reach $7.5 billion (approximately 10 trillion won) by 2030.
2023-12-19 03:17:00
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