Boehringer's Nerandomilast Achieves Phase III Primary Endpoint in Progressive Pulmonary Fibrosis

Boehringer Ingelheim, a leading biopharmaceutical firm in Germany, announced significant advancements in its FIBRONEER™-ILD clinical trial on February 10, 2025. This trial, part of a larger global program, achieved its primary goal by showing a notable improvement in forced vital capacity (FVC) over 52 weeks compared to a placebo. FVC is an important measure of lung function, particularly in assessing the condition of patients with various forms of lung diseases.

The FIBRONEER™ program comprises two major Phase III trials, FIBRONEER™-IPF and FIBRONEER™-ILD, aimed at investigating the efficacy, safety, and tolerability of the investigational drug nerandomilast (BI 1015550). This compound is a selective inhibitor of phosphodiesterase 4B (PDE4B) and is currently being evaluated for its potential to treat idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). The trials involve more than 1,178 patients across 40 countries, highlighting the international scope and significance of this research.

The recent data from the FIBRONEER™-ILD trial indicate that nerandomilast could be a promising treatment option for individuals suffering from progressive pulmonary fibrosis. The findings suggest that the drug might help mitigate the challenges associated with current treatments, offering hope for improved management of this debilitating disease. This study has also shown a safety and tolerability profile that is consistent with previous Phase II studies, with adverse events similar to those observed in the placebo group.

Nerandomilast's potential was recognized by the U.S. FDA, which granted it Breakthrough Therapy Designation in February 2022 for treating IPF. This designation underscores the drug's promise in addressing significant unmet medical needs. Boehringer Ingelheim plans to submit a new drug application for nerandomilast to the US FDA and other global health authorities based on the positive results from the FIBRONEER™-ILD trial.

The FIBRONEER™-ILD trial was a double-blind, randomized, placebo-controlled study that assessed the drug's efficacy and safety over 52 weeks. Patients in the trial were administered either 9 mg or 18 mg of nerandomilast or a placebo twice daily. The trial's primary endpoint focused on the absolute change in FVC, while a secondary endpoint evaluated the timing of acute exacerbations, hospitalizations due to respiratory issues, or death.

Idiopathic pulmonary fibrosis (IPF) is a prevalent type of fibrosing interstitial lung disease. It is characterized by symptoms such as breathlessness during physical activity, persistent dry cough, fatigue, and general weakness. Although IPF is classified as a rare disease, it affects approximately three million people globally, predominantly impacting those over the age of 50, with a higher incidence in men.

Progressive pulmonary fibrosis, on the other hand, can arise from various non-IPF fibrosing lung diseases. It is characterized by worsening respiratory symptoms and further lung function decline, often leading to irreversible damage and increased mortality risk.

Boehringer Ingelheim stands at the forefront of pulmonary fibrosis research, driven by its commitment to transforming patient lives through innovative treatment strategies. As one of the top investors in research and development, the company aims to address the unmet medical needs across different therapeutic areas, maintaining a long-term vision towards sustainability and global health improvement. With more than 53,500 employees worldwide, Boehringer continues to pioneer efforts in creating a healthier, more equitable future.