Boehringer Ingelheim has announced that its investigational drug, nerandomilast (BI 1015550), has successfully met the primary endpoint in the phase III FIBRONEER™-ILD study. The trial assessed the absolute change from baseline in forced vital capacity (FVC) [mL] at Week 52 compared to placebo in individuals with progressive pulmonary fibrosis (PPF).
Idiopathic pulmonary fibrosis (IPF) is one of the most common forms of progressive fibrosing interstitial lung disease (ILD).1Although classified as a rare disease, IPF affects approximately 3 million people worldwide, primarily those over the age of 50, with a higher prevalence in men.2 Beyond IPF, certain non-IPF fibrosing ILDs can also progress into a condition known as PPF, which can cause irreversible lung damage, ultimately leading to early mortality.3 Given the limited treatment options for PPF, there is a significant need for new therapeutic approaches
Nerandomilast is an investigational oral preferential inhibitor of phosphodiesterase 4B (PDE4B). It is being evaluated as part of the FIBRONEER™ global clinical program, which includes two phase III studies—FIBRONEER™-IPF, targeting individuals with IPF, and FIBRONEER™-ILD, focused on patients with PPF.
In the FIBRONEER™-ILD study, participants received either nerandomilast at doses of 9 mg or 18 mg twice daily, or a placebo, over a treatment period of at least 52 weeks. The 18 mg twice-daily dose was selected based on positive results from the phase II study. An additional 9 mg twice-daily dose was introduced to evaluate the benefit-risk profile at a lower dose and to provide further data on dose-response and exposure-response relationships. Conducted across more than 40 countries and 400 locations, the trial enrolled 1,178 patients.
Boehringer Ingelheim intends to submit a new drug application for nerandomilast to the FDA and other regulatory agencies worldwide for the treatment of PPF. Comprehensive efficacy and safety data from the FIBRONEER™-ILD study is expected to be released in the second quarter of 2025.
References:
- Sauleda J, Núñez B, Sala E, Soriano JB. Idiopathic Pulmonary Fibrosis: Epidemiology, Natural History, Phenotypes. Med Sci (Basel). 2018;6:110.
- European Lung Foundation (2023) IPF – Idiopathic Pulmonary Fibrosis. Available at: https://europeanlung.org/en/information-hub/factsheets/ipf-idiopathic-pulmonary-fibrosis/ (accessed 14 February 2025).
- Cottin, V. Criteria for Progressive Pulmonary Fibrosis: Getting the Horse Ready for the Cart. Am J Respir Crit Care Med. 2023;207:11–3.
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