Daewoong Pharmaceutical has administered bersiporocin to the first patient in its phase 2 study of the candidate treatment for idiopathic pulmonary fibrosis (IPF). The study is being conducted in approximately 30 centers in South Korea, where the company is based, and the United States.
IPF is a rare, progressive disease with growing incidence that is characterized by a buildup of fibrotic tissue in the lungs. Common symptoms include dyspnea, unproductive cough, fine crackles on lung auscultation, and manifestations of connective tissue disease including sicca or arthralgia.
“The phase 2 clinical trial of Daewoong Pharmaceutical’s [bersiporocin] represents an important step in developing treatments that address the shortcomings of existing antifibrotic therapies,” Toby Maher, professor of clinical medicine at USC Los Angeles Keck School of Medicine, California, said.
There is currently no known cure for IPF. There are 2 antifibrotic drugs that have been approved by the US Food and Drug Administration (FDA) to slow the decline in lung function, nintedanib and pirfenidone. However, they do not stop disease progression or reverse fibrosis, and they are known to have significant side effects.
Read more about IPF therapies
Management of IPF can include long-term oxygen therapy, respiratory rehabilitation, symptom and comorbidity management, and palliative care. Lung transplantation can prolong survival but is often inappropriate for patients with IPF due to their advanced age.
The multinational phase 2 study has enrolled 102 patients and aims to assess the safety and effectiveness of bersiporocin compared to placebo, as measured by changes in forced vital capacity (FVC) over a period of 24 weeks. The study is estimated to be completed in 2024.
If bersiporocin is proven to have antifibrotic efficacy and improve pulmonary function, it is expected to be adaptable to various fibrotic diseases of the liver, skin, heart, lungs, and kidneys in addition to IPF.
Daewoong Pharmaceutical begins the first administration of the bersiporocin, new treatment for idiopathic pulmonary fibrosis, as phase II clinical trial. News release. Daewoong Pharmaceutical Co, Ltd; February 6, 2023.