Boehringer’s nerandomilast meets primary endpoint in Phase III study FIBRONEER-ILD, in progressive pulmonary fibrosis
February 10, 2025 – Clinical Trials, Drug Discovery, Other, Pharmaceutical – Boehringer Ingelheim, FDA, clinical trials, new drug application, progressive pulmonary fibrosis
- Topline data from FIBRONEER™-ILD show that the investigational compound nerandomilast met its primary endpoint, which was the absolute change from baseline in forced vital capacity [mL] at week 52 versus placebo
- The FIBRONEER™-ILD trial is the second Phase III trial in which the investigational compound nerandomilast has met its primary endpoint
- Initial safety and tolerability results of the FIBRONEER™-trials are generally consistent with the Phase II results in IPF; full efficacy and safety data from FIBRONEER™-ILD will be shared in the second quarter of 2025
- Boehringer Ingelheim will submit a new drug application for nerandomilast for the treatment of PPF to the US Food & Drug Administration (FDA) and other health authorities worldwide.
10 February 2025 — Ingelheim, Germany — Boehringer Ingelheim announced today that the FIBRONEER™-ILD trial met its primary endpoint, which was the absolute change from baseline in forced vital capacity (FVC) [mL] at week 52 versus placebo. FVC is a measure of lung function. Initial data readouts of the FIBRONEER™-trials support a generally consistent safety and tolerability profile when compared to the Phase II idiopathic pulmonary fibrosis (IPF) study, with overall adverse events comparable to those seen in the placebo group.
Nerandomilast is an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B). As it has not been approved for use, safety and efficacy have not been established. It is being investigated as part of the FIBRONEER™ global program, which includes two Phase III studies —FIBRONEER™-IPF in people living with IPF and FIBRONEER™-ILD in people living with progressive pulmonary fibrosis (PPF).
Based on these results, Boehringer Ingelheim will submit a new drug application for nerandomilast for the treatment of PPF to the US FDA and other health authorities worldwide.
“The positive FIBRONEER™-ILD topline result shows the potential of nerandomilast in progressive pulmonary fibrosis. The hope is that the safety and tolerability profile we are initially seeing could potentially help to reduce treatment challenges,” said Shashank Deshpande, Head of Human Pharma and Member of the Board of Managing Directors at Boehringer Ingelheim. “The recent milestones of the FIBRONEER™ trial program underscore our commitment to transforming the lives of patients with this debilitating disease, and are a testament to Boehringer Ingelheim’s position at the forefront of pulmonary fibrosis research.”
About Boehringer Ingelheim
Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. More than 53,500 employees serve over 130 markets to build a healthier, more sustainable, and equitable tomorrow. Learn more at www.boehringer-ingelheim.com.
