Boehringer Ingelheim's investigational compound nerandomilast has met its primary endpoint in the pivotal Phase III FIBRONEER-IPF trial. The trial demonstrated a statistically significant absolute change from baseline in Forced Vital Capacity (FVC) at week 52 compared to placebo, marking a significant step forward in the treatment of idiopathic pulmonary fibrosis (IPF). The company plans to submit a new drug application to the US FDA and other health authorities worldwide.
Trial Details and Results
The FIBRONEER-IPF trial (NCT05321069) is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of nerandomilast in patients with IPF. The trial enrolled 1177 patients across more than 30 countries, making it the largest IPF trial conducted to date. Participants were randomized to receive either 9 mg or 18 mg of oral nerandomilast twice daily, or placebo, for at least 52 weeks.
The primary endpoint was the absolute change from baseline in FVC (mL) at Week 52. A 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.
Full efficacy and safety data from the trial will be presented in the first half of 2025.
Nerandomilast: A Novel Approach to IPF Treatment
Nerandomilast (BI 1015550) is an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B). It is being investigated as a potential treatment for both idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). The FDA granted Breakthrough Therapy Designation to nerandomilast for the treatment of IPF in February 2022.
In a Phase II trial, nerandomilast demonstrated a change from baseline in FVC over a 12-week treatment period (n=147).
Addressing the Unmet Needs in IPF
IPF is a progressive fibrosing interstitial lung disease (ILD) affecting approximately 3 million people worldwide. Symptoms include breathlessness, a dry cough, chest discomfort, fatigue, and weakness. The disease primarily affects individuals over 50, with a higher prevalence in men.
“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.”
The FIBRONEER program also includes the FIBRONEER-ILD trial (NCT05321082) in patients with Progressive Pulmonary Fibrosis (PPF).
