Boehringer Ingelheim announced the start of a phase IIa clinical trial evaluating BI 765423, a novel monoclonal antibody targeting interleukin-11 (IL-11), in patients with Idiopathic Pulmonary Fibrosis (IPF). This study marks a significant milestone in the company’s commitment to advancing care for people living with progressive fibrotic lung diseases.

“With BI 765423, we aim to go beyond slowing disease and to pursue next-generation therapies that could restore lung functionality for people living with IPF. Our aim is to transform the lives of patients and their families by demonstrating the potential of this first-in-class IL-11 inhibitor to deliver clear benefits for patients, backed by compelling evidence and delivered at speed,” said Vittoria Zinzalla, Global Head -- Experimental Medicine, Boehringer Ingelheim.

IL-11 plays a key role in fibrosis across multiple organs and pre-clinical studies have shown that anti-IL-11 treatment can halt fibrosis and restore barrier function, resulting in improved lung function and tissue integrity. BI 765423 is designed to bind directly to IL-11, blocking its interaction with its receptor and thereby interrupting the signalling pathways that cause fibrosis. By targeting this mechanism, BI 765423 aims not only to slow lung damage, but also to help restore lung functionality.

IPF is a progressive, life-shortening lung disease that affects more than three million people worldwide and most patients experience worsening breathlessness and declining lung function. It is deadlier than many forms of cancer, with a lower five-year survival rate compared to prostate cancer, female breast cancer and colon cancer. IPF substantially impacts quality of life and half of patients succumb to the disease within five years of diagnosis. Current medicines can slow disease progression but cannot fully halt lung function decline or reverse lung scarring. There remains a high unmet need for stopping disease progression or reversing the effects of IPF.

In phase-I studies, BI 765423 showed a favourable safety and tolerability profile in healthy volunteers across a wide dose range. The phase IIa study will be the first to evaluate its efficacy in patients with IPF. It is an acquired asset from Enleofen with in-licensed IP from Singapore Health Services and the National University of Singapore.