Daewoong Pharmaceutical Fibrosis New Drug 'DWN12088' Designated as Rare Drug by US FDA

Rare Drugs for Systemic Sclerosis Following Idiopathic Pulmonary Fibrosis

Daewoong Pharmaceutical Exterior (Photo by Daewoong Pharmaceutical)

[Asia Economy Reporter Kim Ji-hee] Daewoong Pharmaceutical announced on the 24th that ‘DWN12088’ has been additionally designated as an orphan drug for systemic sclerosis by the U.S. Food and Drug Administration (FDA). This is the second time DWN12088 has been designated as an orphan drug, following its designation in 2019 for idiopathic pulmonary fibrosis.

Systemic sclerosis is a disease in which the skin hardens starting from the fingertips and eventually affects major organs such as the lungs and heart. Currently, there are no approved drugs for its treatment.

Daewoong Pharmaceutical is developing DWN12088 as a treatment for systemic sclerosis, based on the understanding that excessive collagen accumulation causes tissues and organs to harden. The potential of DWN12088 as a treatment for systemic sclerosis has been confirmed through preclinical trials. If approved as a treatment, it is expected to be the world’s first drug capable of treating not only systemic sclerosis but also interstitial lung disease accompanied by systemic sclerosis.

The FDA’s Orphan Drug Designation (ODD) is a system that supports the development and approval of treatments for rare and intractable diseases. Treatments granted ODD receive benefits such as exemption from new drug application review fees, priority review application rights, and seven years of market exclusivity upon approval.

Daewoong Pharmaceutical is developing DWN12088 as the world’s first fibrosis treatment that inhibits the PRS protein. DWN12088 works by reducing the activity of the PRS protein, which influences collagen production, thereby suppressing the excessive collagen formation that causes fibrosis. Recently, safety, pharmacokinetic properties, and potential as a treatment for idiopathic pulmonary fibrosis were confirmed in a Phase 1 clinical trial in Australia. Plans are underway to apply for Phase 2 clinical trials in the U.S. and Korea within this year.

Seung-ho Jeon, CEO of Daewoong Pharmaceutical, stated, "DWN12088 has achieved the great success of being designated as an orphan drug for systemic sclerosis following idiopathic pulmonary fibrosis. We will continue to develop it as a treatment for fibrosis that can occur in various organs and contribute to the treatment of rare diseases."

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