- Evaluation of Bersiporocin's safety and efficacy against a total of 102 patients over 24 weeks

- Development of treatment for pulmonary fibrosis which is unsatisfactory and in high demand, and anticipation for extended adaptability against various rare fibrosis diseases

SEOUL, South Korea, Feb. 6, 2023 /PRNewswire/ -- The world's first-in-class candidate substance against idiopathic pulmonary fibrosis, 'Bersiposocin' (DWN12088), which is under development Daewoong Pharmaceutical, has entered its Phase II clinical administration.

Daewoong Pharmaceutical (CEO Changjae Lee & Seng-ho Jeon) has announced that the first patient has been administrated in Phase II on the 6th. The Bersiporocin's multinational Phase II has been performed by approx. 30 institutions in Korea and US. A total of 102 patients are evaluated for the safety of Bersiporocin and the efficacy of changes in the improvement rate of FVC(forced vital capacity) after administering the Bersiporocin or placebo for 24 weeks. They are aiming to complete the administration to the subjects and check the results by 2024.

Daewoong Pharmaceutical is planning to prove Bersiporocin's excellent antifibrotic efficacy and pulmonary function improvement results with the oncoming multinational Phase II clinical administration, which has been confirmed from the last non-clinical test. If Daewoong Pharmaceutical succeeds in Bersiporocin's Proof of Concept, it will be probable for the extended adaptability against various rare fibrosis diseases as well as the export of technology.

The main disease which Bersiporocin is effective against is idiopathic pulmonary fibrosis, which is a lung disease caused by overly formed fibrous tissue hardening the lungs, resulting the lungs to lose the function of them. It is known a rare and complicated disease with a 5-year survival rate of less than 40% after diagnosis, as it is challenging to treat. The current treatment for the idiopathic pulmonary fibrosis in the market by multinational pharmaceutical companies cannot completely stop the process of the disease and has a high rate of giving up on the administration due to side effects, so the medical demand for such treatment is still high.

"We are working hard to develop a new treatment for patients with idiopathic pulmonary fibrosis." said the chair of the Trial steering committee, Toby Maher, M.D., Ph.D., Professor of Clinical Medicine, Keck School of Medicine, USC Los Angeles. "The Phase II clinical trial of Daewoong Pharmaceutical's Bersiposocin represents an important step in developing treatments that address the shortcomings of existing anti fibrotic therapies."

An official from Daewoong Pharmaceutical mentioned that "Daewoong Pharmaceutical has set the significant first step to the patients by registering the first candidate and completing the Phase II clinical administration of Bersiporocin, the First-in-class treatment which is under self-development." and "To secure the success of its clinical results, we will focus on empowering Daewoong Pharmaceutical's new drug development capabilities."

According to the global market research institution Research And Markets, the global market of idiopathic pulmonary fibrosis treatment is growing by 7% each year, and anticipated to reach approx. 6.1 billion dollars (approx. 8 trillion won) by 2030. Daewoong Pharmaceutical will continue to make efforts on developing highly-demanded treatment for the fibroid lung patients, as well as extending the target to other progressive rare fibrosis diseases of the lung, skin, kidney, liver, and heart.