Posted on 02/01/2024 09:08Modified on 02/01/2024 10:02


Daewoong Pharmaceutical's Bersiporocin Receives ‘Orphan Drug Designation’ in Europe to Treat Idiopathic Pulmonary Fibrosis

Daewoong Pharmaceutical's Bersiporocin (DWN12088) has been recognized as a significant advancement in treating idiopathic pulmonary fibrosis (IPF), a rare and debilitating disease. This first-in-class PRS inhibitor has recently received ‘Orphan Drug Designation (ODD)’ from the European Medicines Agency (EMA), adding to its earlier designation by the U.S. FDA for both IPF and systemic sclerosis.

The EMA's recognition highlights Bersiporocin's potential to meet critical needs in rare diseases, targeting conditions affecting fewer than 5 in 10,000 individuals in the EU. The designation offers several benefits, including guidance on clinical trials, reduced authorization fees, and 10-year market exclusivity upon approval.

IPF is characterized by abnormal collagen accumulation in the lungs, reducing lung function. With a global incidence rate of about 13 cases per 100,000 people and a 5-year survival rate of only 40%, there's a pressing need for more effective and safer treatments.

Bersiporocin's mechanism involves inhibiting PRS (Prolyl-tRNA Synthetase), thus targeting the excess collagen production that leads to fibrosis. The drug's efficacy was demonstrated in a study published by the European Molecular Biology Organization (EMBO).

In addition to orphan drug designations, Bersiporocin has been granted fast track designation by the FDA. It also has been recognized in the ‘Clinical Development Support’ program by the Korea Drug Development Fund (KDDF). Bersiporocin has successfully completed phase 1 clinical trials in Korea and Australia, establishing its safety and pharmacokinetic properties in 162 healthy subjects. Multinational phase 2 clinical trials are currently in progress in Korea and the U.S. 

Seng-ho Jeon, CEO of Daewoong Pharmaceutical, stated, "With Bersiporocin's global recognition and its clinical advancements, we are more committed than ever to delivering this promising treatment to IPF patients, potentially transforming the landscape of this challenging disease."

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