Leticia Orsatti, MD, Vice President of Clinical Development and Medical Affairs at Boehringer Ingelheim, discusses results from clinical trials examining the safety and efficacy of nerandomilast to treat patients with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF).
IPF is a chronic, progressive, fibrosing lung disease. Common symptoms of IPF include shortness of breath and difficulty performing daily activities, such as walking and talking. The condition commonly affects those over the age of 50 years and is more prominent in men than women. The underlying cause of disease is unknown.
Nerandomilast is an investigational, oral, preferential inhibitor of phosphodiesterase 4B. The phase 3 FIBRONEER-IPF and FIBRONEER-ILD trials are evaluating nerandomilast in patients with IPF and PPF. Recently, results were published in the New England Journal of Medicine (IPF and PPF) and presented at the American Thoracic Society 2025 International Conference.
FIBRONEER Clinical Trial Program
The FIBRONEER-IPF trial was a phase 3, double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of nerandomilast over at least 52 weeks in patients with IPF. The trial enrolled a total of 1,177 patients who were randomly assigned to receive nerandomilast 9 mg twice daily, 18 mg twice daily, or placebo twice daily.
The FIBRONEER-ILD trial was a phase 3, double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of nerandomilsat over at least 52 weeks in patients with PPF. The trial enrolled a total of 1,176 patients who were randomly assigned to receive nerandomilast 9 mg twice daily, 18 mg twice daily, or placebo twice daily.
Both trials met their primary endpoints at both the 9 mg and 18 mg dose, measured by reduction in absolute change from baseline in forced vital capacity decline at week 52 versus placebo. However, neither trial met key secondary endpoints of time to first acute IPF/ILD exacerbation, first hospitalization for respiratory cause, or death.
Safety and tolerability were consistent with both trials having similar rates of permanent treatment discontinuation to placebo. Adverse events of special interest included vasculitis, depression, suicidality, and drug induced liver injury.
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To learn more about IPF and other rare lung conditions, visit https://checkrare.com/diseases/lung-diseases/