Boehringer Ingelheim has launched clinical development of its first-in-class IL-11 inhibitor antibody BI 765423 with a Phase 1 study (NCT05658107) to assess the safety, tolerability, and pharmacokinetics in healthy volunteers. The IL-11 inhibitor antibody is the first of its kind to reach clinical development stage and is based on a partnership between the company and Enleofen Bio Pte. Ltd., with a goal to improve patient outcomes.

‘Fibrotic disease’ is a term that covers a range of diseases characterized by uncontrolled and progressive fibrosis, or scarring, of various organs and tissues. It can be triggered by different factors (such as infections, inflammation, autoimmune disorders, degenerative diseases, tumors, and injury), can cause organ dysfunction/failure, and affect the quality of life and survival of patients. Some examples of fibrotic diseases are, systemic sclerosis, graft-versus-host disease as well as heart, lung, liver, and kidney fibrosis. Current treatments have led to progress in some areas, however fibrotic diseases remain to be a leading cause of morbidity/mortality and account for more than one third of deaths worldwide.

IL-11 plays a key role in fibrosis across multiple organs and preclinical studies have shown that anti-IL-11 treatment has the potential to stop – and even reverse fibrosis – in different fibrotic diseases. Boehringer Ingelheim joined forces with Enleofen, a leader in IL-11 biology, in 2020.

The IL-11 program complements Boehringer’s clinical fibrotic disease pipeline portfolio which includes BI 1015550, a phosphodiesterase 4B (PDE4B) inhibitor, under investigation in two Phase III randomized, double-blind, placebo-controlled trials—FIBRONEER-IPF (NCT05321069) and FIBRONEER-ILD (NCT05321082)—to investigate the efficacy, safety and tolerability of BI 1015550 over at least 52 weeks in patients with IPF and in patients with other progressive fibrosing ILDs and several other clinical stage programs.

“The initiation of this trial is an important milestone for Boehringer Ingelheim and brings us closer to achieving our aim of transforming lives of people living with fibrotic diseases,” said Clive Wood, corporate senior vice president and global head of discovery research at Boehringer Ingelheim. “The effects shown for anti-IL-11 preclinically are impressive and could, if confirmed in the clinic, herald a dramatic advance in the treatment of fibrotic diseases.”