Boehringer Ingelheim (BI) has unveiled results from two late-stage studies of nerandomilast in idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).
The phase 3 FIBRONEER-IPF and FIBRONEER-ILD trials have been evaluating the candidate in patients with IPF and PPF, respectively, with and without background anti-fibrotic therapy.
Results presented at this year’s American Thoracic Society International Conference showed that the trials met their primary endpoint at both doses, with nerandomilast 9mg and 18mg significantly reducing decline in forced vital capacity, a measure of lung function, by absolute change from baseline at week 52 compared to placebo.
Neither study met the composite key secondary endpoint of time to first acute IPF/interstitial lung disease (ILD) exacerbation, first hospitalisation for respiratory cause or death, BI said. However, the company outlined that death occurred in a “numerically smaller” proportion of patients treated with nerandomilast than placebo in FIBRONEER-ILD.
Similar rates of permanent treatment discontinuation to placebo were observed across both trials, with adverse events in FIBRONEER-IPF leading to permanent discontinuation of the trial regimen in 14% of patients in the nerandomilast 18mg group, 11.7% of those in the nerandomilast 9mg group and 10.7% of the placebo group.
In FIBRONEER-ILD, 10% in the nerandomilast 18mg group, 8.1% in the nerandomilast 9mg group, and 10.2% in the placebo group discontinued the trial regimen due to adverse events.
IPF, which primarily affects adults aged over 50 years, is one of the more common progressive fibrosing ILDs. The condition causes the lungs to become scarred and results in symptoms such as breathlessness during activity, a dry and persistent cough, fatigue and weakness.
Patients with specific types of non-IPF fibrosing ILD may also go on to develop PPF, characterised by worsening respiratory symptoms, as well as physiological and radiological evidence of disease progression.
Nerandomilast is an orally-administered preferential inhibitor of phosphodiesterase 4B and is currently under review for IPF and PPF in the US, EU and China.
Shashank Deshpande, head of human pharma and member of the board of managing directors at BI, said: “IPF and PPF are devastating conditions, with one in two people dying within five years of IPF diagnosis. Despite this stark reality, ongoing research may provide new possibilities for patients, as there remains a need for additional therapies.
“The latest efficacy, safety and tolerability data on nerandomilast points to its potential in addressing the needs of those impacted by IPF and PPF.”