-Boehringer Ingelheim announced  that it 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. Boehringer Ingelheim is already a global leader in the treatment of pulmonary fibrosis, and the initiation of clinical development of the anti-IL-11 treatment reflects the company’s long-term commitment to combat fibrotic disease across therapeutic areas.

‘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 pre-clinical 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 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 R. Wood, Ph.D., 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.”

“Enleofen is very excited to see the IL-11 inhibitor partnership with Boehringer Ingelheim, a leader in anti-fibrotic therapy R&D, moving forward into the clinic to address unmet patient needs,” said Prof Stuart Cook, co-founder of Enleofen and Tanoto Foundation Professor of Cardiovascular Medicine at the SingHealth Duke-NUS Academic Medical Centre and the Cardiovascular & Metabolic Disorders Programme at Duke-NUS Medical School, Singapore.

The IL-11 program complements Boehringer Ingelheim’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.