A potential treatment for idiopathic pulmonary fibrosis (IPF) has been given Fast Track Designation by the US Food and Drug Administration (FDA), according to a press release from its manufacturer, Daewoong Pharmaceutical.

The antifibrotic agent is a prolyl-tRNA synthetase (PRS) inhibitor named DWN12088. It could potentially reduce the overproduction of collagen by inhibiting PRS, a key enzyme for the synthesis of the molecule. Collagen, although necessary for many structural functions, can be harmful when produced in an abundant manner.

The efficacy of DWN12088 is currently being researched, with results from the first phase of its clinical trial suggesting outstanding antifibrotic effects and subsequent improvement of lung function. These findings led to the Fast Track designation, Daewoong said in its statement.


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DWN12088 would be the first PRS inhibitor to be available for patients. Patients with IPF currently have a shortage of therapeutic options with clear guidelines on dosage, administration, and efficacy. Many individuals with this disease often do not adhere to their treatment plan due to the side effects of treatments.

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Despite previous efforts and available treatment options, fewer than 40% of patients diagnosed with IPF achieve 5-year survival.

“Idiopathic pulmonary fibrosis is a disease with high unmet medical needs despite the existence of treatments,” Seng-Ho Jeon, chief executive officer of Daewoong, said.

IPF is characterized by the progressive loss of pulmonary function secondary to continuous fibrosis in the lung tissue that makes it stiff and hence unable to expand and comply with basic functions such as gas exchange.

Reference

Daewoong Pharmaceutical gets first Korean US FDA fast-track for new idiopathic pulmonary fibrosis drug. News release. Daewoong Pharmaceutical Co, Ltd; July 20, 2022.