Pivotal phase-III FIBRONEER-IPF study of nerandomilast meets primary endpoint : Boehringer Ingelheim

Boehringer Ingelheim announced that the FIBRONEER-IPF trial successfully met its primary endpoint, demonstrating a significant change in Forced Vital Capacity (FVC) at week 52 compared to placebo. FVC is a key measure of lung function. Following these positive results, Boehringer Ingelheim plans to submit a new drug application for nerandomilast to the US FDA and other global health authorities. The FDA previously granted Breakthrough Therapy Designation for nerandomilast in 2022.

Nerandomilast is an investigational oral phosphodiesterase 4B (PDE4B) inhibitor, currently under investigation in two phase III studies within the FIBRONEER program: FIBRONEER-IPF for idiopathic pulmonary fibrosis (IPF) and FIBRONEER-ILD for progressive pulmonary fibrosis (PPF). The trial involved 1,177 participants across 30 countries and compared different doses of nerandomilast to a placebo over at least 52 weeks.

IPF affects about 3 million people globally, primarily those over 50, and symptoms include breathlessness, cough, and fatigue.