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

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. 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...

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."

Forward-Looking Statements

This press release contains forward-looking statements that are based on the current beliefs and expectations of Daewoong Pharmaceutical's management. Factors that could cause or contribute to such differences include, but are not limited to: (1) Regulatory and governmental approvals: The approval process for pharmaceutical products is subject to extensive regulations and may involve uncertainties and delays. Any failure to obtain necessary approvals or the occurrence of delays in the approval process could adversely affect Daewoong Pharmaceutical's business and results of operations; and (2) Clinical trials: The success of Daewoong Pharmaceutical's products depends on the results of clinical trials. The results of early clinical trials may not be indicative of the results of later-stage or larger-scale clinical trials.

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