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 outcome marks a potentially significant advancement in the treatment of idiopathic pulmonary fibrosis (IPF). The full efficacy and safety data will be presented in the first half of 2025.
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. The trial enrolled 1177 patients across more than 30 countries, making it the largest IPF trial conducted to date. Participants were randomized into three groups receiving either 9 mg or 18 mg of nerandomilast twice daily, or a placebo. 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 component of a composite endpoint: first acute IPF exacerbation, first hospitalization for respiratory cause, or death.
Nerandomilast: A Novel PDE4B Inhibitor
Nerandomilast (BI 1015550) is an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B). It is currently under investigation as a potential treatment for IPF and progressive pulmonary fibrosis (PPF). The FDA granted nerandomilast Breakthrough Therapy Designation for IPF in February 2022. A prior Phase II trial studied the efficacy, safety, and tolerability of nerandomilast in patients with IPF (n=147), with the primary endpoint being the change from baseline in FVC over a 12-week treatment period.
Implications for IPF Treatment
IPF is a progressive fibrosing interstitial lung disease affecting approximately 3 million people worldwide. Symptoms include breathlessness, a persistent cough, and fatigue. According to Ioannis Sapountzis, Head of Global Therapeutic Areas at Boehringer Ingelheim, this is the first IPF phase III trial in a decade to meet its primary endpoint. The company plans to submit a new drug application for nerandomilast to the US FDA and other health authorities worldwide.
