Nerandomilast Meets Primary Endpoint in Phase III Idiopathic Pulmonary Fibrosis Trial

Boehringer Ingelheim announced plans to submit a new drug application (NDA) to the US Food and Drug Administration (FDA) after its Phase 3 trial for nerandomilast met its primary endpoint for the treatment of idiopathic pulmonary fibrosis (IPF), according to a company news release.¹

According to topline data from the phase III study, FIBRONEER-IPF, nerandomilast demonstrated an improvement in lung function at week 52 compared with placebo. Full efficacy and safety results are expected in the first half of 2025, according to the news release.

“This is the first IPF phase-III-trial in a decade to meet its primary endpoint,” said Ioannis Sapountzis, Head of Global Therapeutic Areas at Boehringer Ingelheim.“Today’s announcement represents the next step in our long history in the research of this disease. IPF has a high unmet need for patients, and we are continuously fostering our research activities to develop more options for one of the most common interstitial lung diseases.”

Nerandomilast is an investigational oral, preferential inhibitor of phosphodiesterase 4B that is being studied as a potential treatment for IPF and progressive pulmonary fibrosis (PPF). Nerandomilast was granted FDA Breakthrough Therapy Designation for the treatment of IPF in February 2022.

The global, randomized, double-blind, placebo-controlled FIBRONEER-IPF trial enrolled 1177 patients at more than 330 sites across 30 countries, making it the largest clinical trial conducted to date in IPF, the news release stated. The primary endpoint for the trial was the absolute change from baseline in Forced Vital Capacity (mL) after 52 weeks of treatment. Nerandomilast was assessed at twice-daily doses of 9 mg and 18 mg, with the 18 mg dose informed by results from a prior phase II trial.

IPF is one of the more common progressive fibrosing interstitial lung diseases, affecting approximately 3 million people worldwide. Key symptoms include breathlessness during activity, dry persistent cough, chest discomfort, fatigue, and weakness. In addition to IPF, patients with certain fibrosing ILDs may develop PPF, which is defined by worsening respiratory symptoms, physiologic progression, and radiologic changes.

Reference

1. Boehringer’s nerandomilast meets primary endpoint in pivotal phase-III FIBRONEER™-IPF study [news release]. Ingelheim, Germany; September 16, 2024. https://www.boehringer-ingelheim.com/human-health/lung-diseases/pulmonary-fibrosis/nerandomilast-primary-endpoint-phase-3-fibroneer-ipf-met