Daewoong Pharmaceutical said Monday that its drug candidate for idiopathic pulmonary fibrosis (IPF), bersiporocin (DWN12088), has received orphan drug designation ODD) from the European Medicines Agency (EMA).

Bersiporocin is a Prolyl-tRNA Synthetase (PRS) inhibitor drug candidate that reduces the action of PRS proteins that affect collagen production and inhibits the excessive production of collagen that causes fibrosis.

Daewoong Pharmaceutical confirmed the safety and pharmacokinetic properties of bersiporocin in phase 1 clinical trials with 162 patients in Korea and Australia and is currently conducting a phase 2 study in Korea and the U.S.

Orphan drug designation is a system that facilitates the development and approval of treatments for rare diseases.

The EMA designates orphan drugs for diseases that affect fewer than 5 in 10,000 people in Europe, where there is a high unmet medical need and where a significant benefit is expected for patients.

Drugs granted orphan drug designation by the EMA receive benefits such as scientific advice on clinical trials, reduced authorization fees, and ten years of exclusive marketing authorization in the EU.

IPF is an obstinate disease characterized by abnormal buildup of collagen in the lungs, resulting in loss of lung function, and affects approximately 13 people per 100,000 people worldwide.

Also, IPF is a deadly disease with a poor prognosis, with a five-year survival rate of only 40 percent, but existing treatments have severe side effects with an urgent need for new drugs, Daewoong said.

According to global market research firm, Research and Markets, the IPF therapeutics market is expected to grow at a high rate of 8 percent annually, reaching $7.5 billion by 2030.

"Bersiporocin has been receiving global attention since its clinical stage," said Jeon Seng-ho, CEO of Daewoong Pharmaceutical. "With this EMA orphan drug designation, we will further strive to develop the drug so that we can quickly provide treatment options for patients suffering from IPF."