Daewoong Pharmaceutical's Idiopathic Pulmonary Fibrosis New Drug 'DWN12088' Selected for National New Drug Development Project

Speed of Multinational Phase 2 Clinical Trials in Korea and the United States

Daewoong Pharmaceutical headquarters. [Photo by Daewoong Pharmaceutical]

[Asia Economy Reporter Lee Gwan-joo] Daewoong Pharmaceutical announced on the 17th that its idiopathic pulmonary fibrosis new drug candidate 'DWN12088,' currently under in-house development, has been selected as a project supported by the National New Drug Development Program.

With DWN12088, which is undergoing multinational Phase 2 clinical trials in Korea and the United States, being selected for this government support project, Daewoong Pharmaceutical expects to take a step further in developing a new drug for the rare disease idiopathic pulmonary fibrosis.

DWN12088 is the world's first PRS (Prolyl-tRNA Synthetase) inhibitor anti-fibrotic new drug developed in-house by Daewoong Pharmaceutical. It has a mechanism that reduces the action of the PRS protein, which affects collagen production, thereby inhibiting the excessive production of collagen that causes fibrosis.

Since DWN12088's anti-fibrotic mechanism does not overlap with those of existing treatments, a synergistic effect in pulmonary fibrosis treatment is expected when administered in combination with existing drugs. The U.S. Food and Drug Administration (FDA) designated DWN12088 as an orphan drug in 2019 and approved its Phase 2 clinical trial and designated it as a fast track development item in June and July of this year.

Additionally, Daewoong Pharmaceutical received approval for the Phase 2 clinical trial plan from the Ministry of Food and Drug Safety in September. The trial will be conducted simultaneously in Korea and the United States using a multinational, multicenter approach with a total of 102 patients. Through multiple Phase 1 clinical trials conducted earlier in Korea and Australia, Daewoong Pharmaceutical confirmed the safety and pharmacokinetic characteristics of DWN12088 in a total of 162 healthy subjects.

Idiopathic pulmonary fibrosis is a lung disease in which the lungs gradually harden and lose function due to excessively generated fibrous tissue. It is known as a rare disease with a survival rate of less than 40% five years after diagnosis due to the difficulty of treatment. Currently marketed idiopathic pulmonary fibrosis treatments cannot completely stop disease progression, and the high dropout rate due to side effects means there remains a significant unmet medical need.

Seung-ho Jeon, CEO of Daewoong Pharmaceutical, said, "Building on the selection of this project supported by the National New Drug Development Program, we will demonstrate the innovative new drug development results in global Phase 2 clinical trials and accelerate development to enable practical use worldwide as soon as possible."

This content was produced with the assistance of AI translation services.