Daewoong Pharmaceutical "Idiopathic Pulmonary Fibrosis New Drug, Safety Confirmed in Australian Phase 1 Clinical Trial"

Clinical Results Revealed at the American Thoracic Society Meeting

Daewoong Pharmaceutical Exterior (Photo by Daewoong Pharmaceutical)

[Asia Economy Reporter Kim Ji-hee] Daewoong Pharmaceutical announced on the 20th that it confirmed the safety of the idiopathic pulmonary fibrosis treatment candidate substance ‘DWN12088’ in Phase 1 clinical trials. The clinical results were disclosed at the American Thoracic Society (ATS2021) held online from the 14th to the 19th (local time).

Daewoong Pharmaceutical conducted single ascending dose (SAD) and multiple ascending dose (MAD) trials on 72 healthy adults of various ethnicities in Australia to assess the safety of DWN12088 as well as its pharmacokinetic properties such as absorption, distribution, and metabolism in the body. The clinical results confirmed the safety of DWN12088, and by analyzing blood concentrations after drug administration, they established a basis for setting the dosage required for treatment. In particular, it is predicted that the concentration of substances causing fibrosis can be reduced depending on the concentration, confirming the potential of DWN12088 as a treatment for idiopathic pulmonary fibrosis, according to the company.

Based on the Phase 1 clinical results, Daewoong Pharmaceutical plans to apply for Phase 2 clinical trials of DWN12088 in Korea and the United States within this year.

Fibrosis is characterized by abnormal increases in collagen within the body, causing tissues or organs to harden. Among these, idiopathic pulmonary fibrosis is a disease in which the lungs gradually stiffen and lose function. It is a difficult-to-treat rare disease with a known 5-year survival rate of less than 40% after diagnosis.

Daewoong Pharmaceutical is developing DWN12088 as the world’s first treatment for idiopathic pulmonary fibrosis. The mechanism involves reducing the action of the PRS protein, which affects collagen production, thereby inhibiting the excessive production of collagen that causes pulmonary fibrosis. It has already been selected as a supported project in the new drug development sector of the Pan-Government New Drug Development Project Group and has received orphan drug designation from the U.S. Food and Drug Administration (FDA).

Jeon Seung-ho, CEO of Daewoong Pharmaceutical, stated, “Through the Phase 1 clinical trial of DWN12088, we confirmed its safety and pharmacokinetic characteristics, laying the foundation for Phase 2 clinical trials. Going forward, we will expand research on fibrosis treatments that can occur in organs such as the heart, liver, kidneys, and skin, and develop it as the world’s first innovative new drug.”

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