Daewoong Pharmaceutical's Bersiporocin Shows Positive Phase 2 Safety Data

Daewoong Pharmaceutical announced on the 29th that its new drug 'Bersiporocin', currently being developed as the world's first treatment for idiopathic pulmonary fibrosis (IPF), has proven its safety in Phase 2 clinical trials.

According to Daewoong Pharmaceutical, the Independent Data Monitoring Committee (IDMC) recommended the continuation of the clinical trial during its second meeting on the 26th. The IDMC found no significant safety issues after reviewing the safety data. The committee will conduct a final safety review in the third meeting scheduled for early next year. The IDMC is responsible for interim reviews of ongoing clinical trials, focusing on safety and efficacy to ensure the scientific validity of the trials.

IPF is a disease where abnormal collagen accumulation in the lungs leads to loss of lung function. The 5-year survival rate post-diagnosis is only 40%, with a generally poor prognosis. Current treatments are limited to slowing the progression of fibrosis and have high rates of adverse reactions, according to Daewoong Pharmaceutical.

In contrast, Bersiporocin is expected to demonstrate distinct safety and efficacy by directly inhibiting collagen synthesis. Since January last year, the company has been conducting Phase 2 trials in the US and Korea on patients over 40 years old. The trials aim to evaluate the safety, tolerability, and efficacy of Bersiporocin, both as a monotherapy and in combination with existing treatments. To date, 61 patients have been recruited, achieving about 60% of the target enrollment of 102 patients, with the Phase 2 trial expected to conclude next year.

Bersiporocin received Orphan Drug designation from the US Food and Drug Administration (FDA) in 2019, Fast Track designation in 2022, and Orphan Drug designation from the European Medicines Agency (EMA) in January this year. Last year, Daewoong also signed a technology export agreement for the Greater China region with CS Pharmaceuticals in the UK, further advancing its entry into the global market.

Chang-jae Lee, CEO of Daewoong Pharmaceutical, stated, "This IDMC recommendation is an important milestone that proves the safety of Bersiporocin. We aim to provide new treatment options for IPF patients through the development of this innovative drug candidate."