On the heels of the positive Phase III data, Boehringer Ingelheim plans to submit a new drug application for nerandomilast to treat PPF to health authorities worldwide including the US Food and Drug Administration (FDA).
The German company reported topline data from a Phase III FIBRONEER-ILD trial (NCT05321082) in progressive pulmonary fibrosis (PPF). The results show that the nerandomilast group met the primary endpoint of absolute change from baseline in forced vital capacity, a measure of lung function, at week 52 versus placebo.
Shashank Deshpande, Head of Human Pharma and Member of the Board of Managing Directors at Boehringer Ingelheim said: “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.”
Phase III trial data
The successful results come six months after Boehringer’s released topline data from another Phase III FIBRONEER-IPF trial (NCT05321069), which evaluated nerandomilast in patients with idiopathic pulmonary fibrosis (IPF). Although the company did not provide detailed results, it noted that the baseline in forced vital capacity (FVC), a measure of lung function, at 52 weeks.
Boehringer also withheld the detailed results from the FIBRONEER-ILD trial. Adding, “initial data readouts of the FIBRONEER-trials support a generally consistent safety and tolerability profile when compared to the Phase II IPF study, with overall adverse events comparable to those seen in the placebo group”.
The placebo-controlled FIBRONEER-ILD study enrolled 1178 participants with PPF other than IPF. The primary endpoint is the absolute change from baseline in FVC (mL) at week 52.4,5 The key secondary endpoint is the time to the first occurrence of any of the components of the composite endpoint: time to first acute IPF/ILD exacerbation, first hospitalization for respiratory cause, or death (whichever occurs first) over the duration of the trials.
Nerandomilast is a preferential inhibitor of phosphodiesterase 4B (PDE4B), which is associated with antiinflammatory and antifibrotic properties. It received an FDA Breakthrough Therapy Designation for the treatment of IPF in February 2022.
