Boehringer Ingelheim has announced positive topline results from the Phase III FIBRONEER-ILD trial, evaluating nerandomilast (BI 1015550) in patients with progressive pulmonary fibrosis (PPF). The trial met its primary endpoint, demonstrating a statistically significant improvement in lung function as measured by the absolute change from baseline in forced vital capacity (FVC) at week 52 compared to placebo.
Nerandomilast's Efficacy in Progressive Pulmonary Fibrosis
The FIBRONEER-ILD trial (NCT05321082) is a double-blind, randomized, placebo-controlled study that enrolled 1,178 patients across more than 40 countries. Participants received either oral nerandomilast (9 mg or 18 mg twice daily) or placebo for at least 52 weeks. The primary endpoint was the absolute change from baseline in FVC (mL) at week 52.
Boehringer Ingelheim plans to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) and other health authorities worldwide based on these results. This follows a previous NDA submission for nerandomilast in idiopathic pulmonary fibrosis (IPF), based on positive results from the FIBRONEER-IPF trial.
Safety and Tolerability Profile
Initial safety and tolerability results from the FIBRONEER trials are reportedly consistent with Phase II data in IPF, with overall adverse events comparable to those seen in the placebo group. Full efficacy and safety data from FIBRONEER-ILD will be shared in the second quarter of 2025.
Shashank Deshpande, Head of Human Pharma and Member of the Board of Managing Directors at Boehringer Ingelheim, stated, "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."
About Nerandomilast
Nerandomilast (BI 1015550) is an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B) being studied as a potential treatment for IPF and PPF. It has not been approved for use, and its efficacy and safety have not been established. The FDA granted nerandomilast Breakthrough Therapy Designation for the treatment of IPF in February 2022.
Current Treatment Landscape and Future Implications
IPF is a progressive fibrosing interstitial lung disease (ILD) affecting approximately 3 million people worldwide. PPF can develop in non-IPF fibrosing ILDs, leading to irreversible lung damage and early mortality. Current treatments, such as Boehringer Ingelheim's Ofev (nintedanib), aim to slow disease progression but do not offer a cure.
If approved, nerandomilast could provide a new treatment option for patients with PPF and IPF, potentially addressing both pulmonary fibrosis and inflammation associated with these conditions. Boehringer Ingelheim aims to move beyond slowing disease progression and ultimately find a cure for pulmonary fibrosis.
