The first patient has been enrolled in Boehringer Ingelheim’s phase 3 trial of BI 1015550 to treat idiopathic pulmonary fibrosis (IPF). The trial is part of the global FIBRONEER program for patients with IPF and other progressive fibrosing interstitial lung diseases (ILDs).
“New treatments for idiopathic pulmonary fibrosis and other forms of progressive fibrosing interstitial lung diseases are needed to complement existing therapies and to help potentially stop, rather than slow, disease progression,” the coordinating investigator, Toby Maher, MD, PhD, professor of clinical medicine at Keck School of Medicine, University of Southern California Los Angeles, said in a press release.
The phase 3, randomized, double-blind, placebo-controlled trial aims to assess the efficacy, safety, and tolerability of BI 1015550 over a 1-year period in patients with IPF.
Read more about IPF therapies
The primary endpoint is the change in lung function from baseline as measured by forced vital capacity (FVC) at week 52. A key secondary endpoint is the time to first acute exacerbation, hospitalization for respiratory reasons, or death. Patient-reported outcomes are also secondary endpoints of the trial. Phase 2 results on BI 1015550 demonstrated positive effects on FVC and superiority to placebo in slowing lung function deterioration in patients with IPF.
IPF is a progressive, fibrosing disease characterized by symptoms including persistent cough, breathlessness, chest pain, weakness, and fatigue. It can lead to irreversible scarring of lung tissue that can become life-threatening. Given that currently available therapies only slow disease progression, new treatments are needed to complement existing therapies and help stop the progression of IPF.
BI 1015550 is an investigational phosphodiesterase 4B inhibitor intended to reduce the fibrosis of the lungs that occurs in IPF and other ILDs. It was granted Breakthrough Therapy designation by the US Food and Drug Administration (FDA) in February 2022.
Boehringer Ingelheim enrolls first patient in phase III trial of BI 1015550 in idiopathic pulmonary fibrosis. News release. Boehringer Ingelheim; October 26, 2022.