First IPF patient dosed in Phase 2 trial of bersiporocin
Trial is testing bersiporocin's effectiveness to treat idiopathic pulmonary fibrosis
The first patient has been dosed in a Phase 2 clinical trial of bersiporocin, Daewoong Pharmaceutical’s treatment candidate for idiopathic pulmonary fibrosis (IPF).
Full patient dosing and initial data from the study are anticipated by 2024, according to Daewoong.
“Daewoong Pharmaceutical has set the significant first step to the patients by registering the first candidate and completing the Phase  clinical administration of Bersiporocin, the First-in-class treatment which is under self-development,” a company official said in a press release.
Pulmonary fibrosis is characterized by lung scarring (fibrosis) driven by an overproduction of collagen, a structural protein that is one of the key components of scar tissue. This results in lung function decline, leading to shortness of breath, low oxygen levels in the blood, and coughing.
In IPF, the most common form of pulmonary fibrosis, the underlying cause is unknown. However, it is well-established that exposure to irritating substances, such as cigarette smoking, being a male, and carrying certain genetic variants, increases the risk one has of developing the disease.
Current treatments for IPF do not stop disease progression completely, and the rate of withdrawal is high due to side effects. Therefore, there is a high demand for effective treatments.
“We are working hard to develop a new treatment for patients with idiopathic pulmonary fibrosis,” said Toby Maher, MD, PhD. Maher is chair of the trial’s steering committee and professor of clinical medicine at the Keck School of Medicine, University of Southern California, in Los Angeles. “The Phase  clinical trial of Daewoong Pharmaceutical’s Bersiposocin represents an important step in developing treatments that address the shortcomings of existing anti fibrotic therapies.”
Bersiporocin, previously known as DWN12088, is an oral anti-fibrotic medication that is designed to block the activity of a protein involved in collagen production. By reducing collagen production, bersiporocin is expected to reduce lung fibrosis and thereby counteract the harmful effects of pulmonary fibrosis on lung function.
The Phase 2 trial (NCT05389215) is underway at about 30 institutions in Korea and the U.S. It aims to enroll up to 102 IPF patients, ages 40 and older, who will be assigned randomly to receive a tablet of bersiporocin or a placebo, twice daily, for 24 weeks (about six months).
The trial will evaluate the safety and tolerability of bersiporocin, as well as its effectiveness at improving lung function. This will be assessed by analyzing the rate of decline of forced vital capacity — a lung function parameter that measures the total amount of air a person can exhale after a deep breath.
With this trial, the company is expecting to provide evidence of bersiporocin’s anti-fibrotic efficacy and ability to improve lung function, which was partially demonstrated in a Phase 1 trial of healthy volunteers in Australia.
If proven effective, bersiporocin may be investigated as a treatment for other rare fibrotic diseases.