Boehringer Ingelheim’s Nerandomilast Succeeds in Second Phase III Lung Fibrosis Trial, Paving Way for FDA Approval

Boehringer Ingelheim's lung disease drug nerandomilast has shown success in the Phase III FIBRONEER-ILD trial for progressive fibrosing interstitial lung diseases (PF-ILDs)1.

The study met its primary endpoint of improving forced vital capacity (FVC) at week 52, indicating improved lung function in patients with PF-ILDs1.

This success follows a previous Phase III trial (FIBRONEER-IPF) that met its primary endpoint for idiopathic pulmonary fibrosis (IPF) in September 202412.

Boehringer Ingelheim plans to submit a New Drug Application (NDA) to the FDA and other health authorities for approval of nerandomilast in patients with progressive pulmonary fibrosis (PPF)1.

Nerandomilast is an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B) and has received FDA Breakthrough Therapy Designation for IPF treatment1.

The FIBRONEER-ILD trial enrolled 1,178 adult patients, allowing concurrent use of Boehringer's existing drug Ofev (nintedanib)1.

Full efficacy and safety data from the FIBRONEER-ILD study are expected to be shared in Q2 20251.

Boehringer Ingelheim already dominates the IPF market with Ofev, which generated $3.8 billion in sales in 20231.

If approved, nerandomilast could potentially become Boehringer's successor to Ofev in the lung diseases space1.

This marks the first time in over a decade that a Phase III IPF trial has met its primary endpoint, signifying a potential breakthrough in lung fibrosis treatment24.

Sources:

1. https://www.clinicaltrialsarena.com/news/nerandomilast-phaseiii-success-ppf-seeks-approval/

2. https://www.pharmaceutical-technology.com/news/boehringer-seeks-approval-for-lung-fibrosis-drug-following-phase-iii-win/

4. https://www.actionpf.org/news/fibroneer-ipf-clinical-trial-results-and-what-this-means-for-people-living-with-pf