Boehringer Ingelheim announced that the Phase III FIBRONEER-IPF trial of nerandomilast met its primary endpoint, demonstrating a statistically significant absolute change from baseline in Forced Vital Capacity (FVC) at week 52 compared to placebo. This marks a significant milestone in the development of a new treatment option for idiopathic pulmonary fibrosis (IPF), a progressive and debilitating lung disease. The trial, conducted across more than 330 sites in over 30 countries, enrolled 1177 patients, making it the largest IPF trial to date.
Nerandomilast: A Novel PDE4B Inhibitor
Nerandomilast (BI 1015550) is an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B). It is being studied for its potential to treat IPF and progressive pulmonary fibrosis (PPF). The drug has not yet been approved for use, and its efficacy and safety are still under evaluation. In February 2022, nerandomilast received Breakthrough Therapy Designation from the FDA for the treatment of IPF.
FIBRONEER-IPF Trial Details
The FIBRONEER-IPF trial (NCT05321069) is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of nerandomilast over at least 52 weeks in patients with IPF. Participants were randomly assigned to receive either 9 mg or 18 mg of oral nerandomilast twice daily, or a placebo. The primary endpoint was the absolute change from baseline in FVC (mL) at Week 52.
The key secondary endpoint included the time to the first occurrence of any of the components of the composite endpoint: time to first acute IPF exacerbation, first hospitalization for respiratory cause, or death (whichever occurs first) over the duration of the trial.
Clinical Significance and Future Steps
"This is the first IPF phase-III-trial in a decade to meet its primary endpoint," said Ioannis Sapountzis, Head of Global Therapeutic Areas at Boehringer Ingelheim. "Today’s announcement represents the next step in our long history in the research of this disease. IPF has a high unmet need for patients, and we are continuously fostering our research activities to develop more options for one of the most common interstitial lung diseases."
Boehringer Ingelheim plans to submit a new drug application for nerandomilast for the treatment of IPF to the US FDA and other health authorities worldwide. Full efficacy and safety data from the trial will be presented in the first half of 2025.
IPF: An Unmet Medical Need
IPF is a progressive fibrosing interstitial lung disease affecting approximately 3 million people worldwide. Symptoms include breathlessness, a dry cough, chest discomfort, fatigue, and weakness. The disease primarily affects individuals over the age of 50 and is more prevalent in men. Current treatment options are limited, highlighting the urgent need for new therapies like nerandomilast.
