Nerandomilast Meets Phase III Endpoint
Boehringer Ingelheim announced that the FIBRONEER-ILD trial met its primary endpoint, which was the absolute change from baseline in forced vital capacity (FVC) [mL] at week 52 versus placebo
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.
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).
Based on these results, Boehringer Ingelheim will submit a new drug application for nerandomilast for the treatment of PPF to the US FDA and other health authorities worldwide.
“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,” said Shashank Deshpande, Head of Human Pharma and Member of the Board of Managing Directors at Boehringer Ingelheim. “The recent milestones of the FIBRONEER trial program underscore our commitment to transforming the lives of patients with this debilitating disease, and are a testament to Boehringer Ingelheim's position at the forefront of pulmonary fibrosis research.”
About FIBRONEER-ILD (NCT05321082)
FIBRONEER-ILD was a double-blind, randomized, placebo-controlled trial evaluating the efficacy and safety of nerandomilast (BI 1015550) over at least 52 weeks in patients with PPF.
1. Primary endpoint: Absolute change from baseline in FVC (mL) at week 52.
2. Key secondary endpoint: Time to the first occurrence of any of the components of the composite endpoint: time to first acute interstitial lung disease (ILD) exacerbation; first hospitalization for respiratory cause; or death (whichever occurs first) over the duration of the trial.
Patients participating in the FIBRONEER-ILD trial were treated with either oral nerandomilast 9 mg or 18 mg, or placebo, twice-daily, over at least 52 weeks. The 18 mg twice-daily dose of nerandomilast is supported by the results from the Phase II study. An additional 9 mg twice-daily dose of nerandomilast was added to evaluate the benefit-risk profile at a lower dose, as well as to provide further dose-response and exposure-response data. The trial has been conducted in more than 40 countries, more than 400 locations, and enrolled 1178 patients.
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