Boehringer delivers positive phase 3 results for lung disease drug

Boehringer Ingelheim's investigational drug nerandomilast has met the primary endpoint in the phase 3 FIBRONEER-IPF study.

The trial, which is the largest ever conducted for idiopathic pulmonary fibrosis (IPF), showed a significant improvement in lung function, measured by the change in Forced Vital Capacity (FVC) at week 52 compared to placebo.

The company now plans to submit a new drug application for nerandomilast to the FDA and other global health authorities. Nerandomilast previously received Breakthrough Therapy Designation from the FDA for the treatment of IPF in 2022.

Boehringer Ingelheim emphasized that this is the first Phase III IPF trial in a decade to achieve its primary endpoint, highlighting the ongoing need for new treatments in this area. Full efficacy and safety data from the FIBRONEER-IPF study will be released in 2025.

Nerandomilast is an oral phosphodiesterase 4B (PDE4B) inhibitor that works by blocking the PDE4B enzyme, which breaks down cyclic adenosine monophosphate (cAMP). By increasing cAMP levels, nerandomilast reduces inflammation, a key factor in IPF, helping to slow lung damage and improve lung function.