Daewoong Pharmaceutical Initiates Multinational Phase 2 Clinical Trial for Idiopathic Pulmonary Fibrosis New Drug 'DWN12088'

US FDA Approves Test Plan... Full-Scale Launch in September

Daewoong Pharmaceutical exterior.

[Asia Economy Reporter Lee Gwan-joo] Daewoong Pharmaceutical announced on the 17th that it has received approval from the U.S. Food and Drug Administration (FDA) for the clinical phase 2 trial plan (IND) of the PRS (Prolyl-tRNA Synthetase) inhibitor 'DWN12088' targeting patients with idiopathic pulmonary fibrosis.

Daewoong Pharmaceutical plans to begin the clinical trial in September. This phase 2 trial will be conducted as a multinational clinical study simultaneously in the U.S. and Korea to evaluate the safety and efficacy of DWN12088. A total of 102 patients with idiopathic pulmonary fibrosis (IPF) will be orally administered the investigational drug or placebo for 24 weeks, and the degree of improvement in forced vital capacity (FVC) decline will be assessed. DWN12088's safety and pharmacokinetic properties were confirmed in multiple phase 1 clinical trials conducted in Australia and Korea involving 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 produced fibrous tissue. It is known as a rare disease with a 5-year survival rate of less than 40% after diagnosis because it is difficult to treat. Currently marketed idiopathic pulmonary fibrosis treatments by multinational pharmaceutical companies cannot completely stop disease progression, and the high dropout rate due to side effects means there remains a high unmet medical need.

DWN12088 is the world's first PRS inhibitor anti-fibrotic new drug developed independently by Daewoong Pharmaceutical. PRS is an enzyme that plays an important role in collagen synthesis, and DWN12088 has a mechanism that reduces the action of the PRS protein affecting collagen production, thereby inhibiting the excessive production of collagen that causes fibrosis. In 2019, it was designated as an orphan drug for idiopathic pulmonary fibrosis by the FDA.

Seung-ho Jeon, CEO of Daewoong Pharmaceutical, said, “Idiopathic pulmonary fibrosis, known as a rare disease, remains one of the diseases with high unmet medical needs despite the existence of existing treatments. Daewoong Pharmaceutical aims to realize its corporate mission to provide innovative new drugs to patients with idiopathic pulmonary fibrosis through DWN12088, fulfilling unmet medical needs and leading the improvement of human quality of life.”

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