Boehringer Ingelheim (BI) has announced positive top-line results from a late-stage study of its investigational nerandomilast in progressive pulmonary fibrosis (PPF).
The phase 3 FIBRONEER-ILD trial randomised more than 1,170 PPF patients to receive one of two doses of the oral candidate or placebo twice daily for at least one year.
The study met its primary endpoint by demonstrating an absolute change from baseline in forced vital capacity (FVC), a measure of lung function, at week 52 versus placebo.
The results come five months after BI revealed that its phase 3 FIBRONEER-IPF of nerandomilast in idiopathic pulmonary fibrosis (IPF) met the same FVC primary endpoint.
BI said in the September announcement that it would be submitting a new drug application (NDA) for nerandomilast in IPF to the US Food and Drug Administration (FDA) and other health authorities worldwide.
Based on the new results from FIBRONEER-ILD, the company will now also be submitting an NDA for the drug in PPF.
IPF is one of the more common progressive fibrosing interstitial lung diseases (ILD), affecting approximately three million people worldwide. The condition, which primarily affects those aged over 50 years, 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 certain types of non-IPF fibrosing ILD may also develop PPF, characterised by worsening respiratory symptoms, as well as physiological and radiological evidence of disease progression.
Nerandomilast is a preferential inhibitor of phosphodiesterase 4B, which is highly expressed in the lungs, where it may play a key role in fibrosis and inflammation.
Shashank Deshpande, head of human pharma and a member of the board of managing directors at BI, said: “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.”
The results come after BI entered into a strategic partnership with Brainomix in July to improve the identification and access to treatment for people living with fibrosing lung disease in the US.