Boehringer's Nerandomilast Promising in Phase 3 Pulmonary Fibrosis Study

Boehringer Ingelheim (BI) has unveiled promising top-line results from a phase 3 study of its investigational drug nerandomilast, aimed at treating progressive pulmonary fibrosis (PPF). This late-stage clinical trial, known as FIBRONEER-ILD, included over 1,170 participants diagnosed with PPF. Each patient was assigned to receive one of two dosages of the oral drug or a placebo, administered twice daily for a minimum duration of one year.

The trial successfully achieved its primary goal by showing a significant improvement in lung function, as measured by forced vital capacity (FVC), compared to the placebo group at the end of 52 weeks. This positive outcome follows BI's earlier announcement, five months prior, that its phase 3 FIBRONEER-IPF trial of nerandomilast for idiopathic pulmonary fibrosis (IPF) also met the same primary endpoint of FVC.

In light of these encouraging findings, BI announced in September that it intends to submit a new drug application (NDA) for nerandomilast to the US Food and Drug Administration (FDA) and other global health authorities for the treatment of IPF. With the new data from the FIBRONEER-ILD trial, BI will extend its NDA submissions to include PPF as well.

IPF is a prevalent form of progressive fibrosing interstitial lung disease (ILD), affecting about three million individuals globally. This disease mainly impacts individuals over 50 years old, leading to lung scarring and symptoms such as breathlessness during physical activities, persistent dry cough, fatigue, and general weakness. Other forms of non-IPF fibrosing ILD can also progress to PPF, which is marked by worsening respiratory conditions and physical and radiological indicators of disease advancement.

Nerandomilast functions as a targeted inhibitor of phosphodiesterase 4B. This enzyme is abundantly present in lung tissue, where it may significantly contribute to fibrosis and inflammation. Shashank Deshpande, who heads human pharma at BI and serves on the company's board of managing directors, remarked on the trial's success, stating, "The positive FIBRONEER-ILD top-line result shows the potential of nerandomilast in PPF. The hope is that the safety and tolerability profile we are initially seeing could potentially help to reduce treatment challenges."

This announcement follows a strategic partnership formed by BI with Brainomix in July, aimed at enhancing the diagnosis and accessibility of treatment for individuals with fibrosing lung diseases in the United States. This collaboration underscores BI's commitment to addressing the unmet needs in lung disease treatment, particularly for those with chronic and progressive conditions such as PPF and IPF.

The study's results not only highlight the efficacy of nerandomilast in improving lung function but also offer hope for improved management of PPF, potentially easing the treatment burden for patients. As BI moves forward with its regulatory submissions, there is optimism that nerandomilast could become a valuable treatment option for patients suffering from these debilitating lung conditions.