• FIBRONEER Phase III program initiated globally to evaluate BI 1015550, a novel investigational phosphodiesterase 4B (PDE4B) inhibitor, in idiopathic pulmonary fibrosis (IPF) and other progressive fibrosing interstitial lung diseases (ILDs)
  • Program to be conducted in more than 40 countries, including the U.S.
  • U.S. Food and Drug Administration (FDA) also granted Orphan Drug Designation for BI 1015550 in IPF

RIDGEFIELD, CT, USA and INGELHEIM, Germany I October 26, 2022 I Boehringer Ingelheim today announced that the first U.S. patient has enrolled in FIBRONEER-IPF, a global Phase III trial evaluating BI 1015550, an investigational phosphodiesterase 4B (PDE4B) inhibitor, in people living with idiopathic pulmonary fibrosis (IPF). The trial is part of the FIBRONEER global program, which includes two Phase III studies—FIBRONEER-IPF in patients with IPF and FIBRONEER-ILD in people living with 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,” said the coordinating investigator, Toby Maher, M.D., Ph.D., Professor of Clinical Medicine, Keck School of Medicine, USC Los Angeles. “We’re excited to build on the positive Phase II results so we can better understand the long-term efficacy, safety and tolerability of this investigational medicine.”

IPF is one of the more common forms of progressive fibrosing ILDs with symptoms that include breathlessness during activity, a dry and persistent cough, chest discomfort, fatigue and weakness. There are more than 200 lung disorders that can lead to pulmonary fibrosis—an irreversible scarring of lung tissue that negatively impacts lung function, quality of life and may become life-threatening.

“The FDA’s approval of Breakthrough Therapy and Orphan Drug Designations for BI 1015550 in idiopathic pulmonary fibrosis reinforces the high unmet need that exists among people living with the devastating impact of this rare disease,” said Donald Zoz, M.D., Director and Senior Clinical Program Leader for Pulmonary Fibrosis at Boehringer Ingelheim. “As the global market leader, we remain steadfast in our commitment to innovating for people living with pulmonary fibrosis. Enrolling the first patient in our Phase III program is a critical step to help bring forward this next generation of treatment to those in need as quickly as possible.”

The FDA grants Orphan Drug Designation to a drug or biological product to prevent, diagnose or treat a rare disease or condition.


The FIBRONEER program includes 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.

In both trials, the primary endpoint is the absolute change from baseline in forced vital capacity (FVC) at week 52. The key secondary endpoint is the time to the first occurrence of any of the components of the composite endpoint: time to first acute IPF/ILD exacerbation, first hospitalization for respiratory cause, or death over the duration of the trials. Additional secondary endpoints include patient-reported outcomes.

The trials were developed with feedback from an external advisory committee, as well as from healthcare providers, caregivers and patients, to best meet the needs of those living with the disease.

For more information about the FIBRONEER program, please visit ClinicalTrials.gov.

About Boehringer Ingelheim

Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. More than 52,000 employees serve over 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. Learn more at www.boehringer-ingelheim.us.

SOURCE: Boehringer Ingelheim