Boehringer’s nerandomilast meets endpoint in Phase III study

Boehringer Ingelheim today revealed that the FIBRONEER-ILD trial of nerandomilast met its primary endpoint, which was the absolute change from baseline in forced vital capacity (FVC) [mL] at week 52 versus placebo.

The German family-owned pharma major noted that 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. 3

The company pointed out that 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).