Boehringer Ingelheim’s investigational compound nerandomilast, which targets the PDE4B enzyme involved in fibrosis and inflammation in the lungs, met its primary endpoint in a late-stage study.
Boehringer Ingelheim on Monday released topline results from the Phase III FIBRONEER-IPF study, demonstrating that its investigational oral drug nerandomilast can significantly improve lung function in patients with idiopathic pulmonary fibrosis.
The German pharma did not provide specific data in its announcement, only that nerandomilast met its primary endpoint by eliciting a significant improvement in forced vital capacity at 52 weeks versus placebo. Boehringer Ingelheim will use the findings from FIBRONEER-IPF to support a drug application for nerandomilast with the FDA and other regulatory authorities worldwide.
The company expects to present full data and analyses from FIBRONEER-IPF in the first half of 2025.
Idiopathic pulmonary fibrosis (IPF) “has a high unmet need for patients,” Ioannis Sapountzis, Boehringer’s head of global therapeutic areas, said in a statement. The disease is one of the more common subtypes of interstitial lung disease, often manifesting as dry and persistent coughs, weakness, fatigue and chest discomfort. Patients also typically reach breathlessness during physical activity.
Nerandomilast addresses IPF by preferentially targeting and inhibiting the phosphodiesterase 4B enzyme, which is highly expressed in the lungs and is believed to be involved in fibrosis and the inflammatory process. The investigational compound works to disrupt these pathways, exerting anti-fibrotic and anti-inflammatory effects on the lungs, according to the pharma’s website.
The FDA gave nerandomilast its Breakthrough Therapy designation for IPF in 2022.
FIBRONEER-IPF is a double-blinded, randomized and placebo-controlled study with nearly 1,200 patients enrolled in more than 30 countries. Nerandomilast was given at high and low doses for 52 weeks, after which patients were assessed for lung function. Key secondary outcomes include the time to the first acute IPF exacerbation or death, and the time to first respiratory hospitalization or death.
FIBRONEER-IPF “is the first IPF Phase III trial in a decade to meet its primary endpoint,” Sapountzis said.
Aside from IPF, Boehringer is also assessing nerandomilast for progressive pulmonary fibrosis, for which it is running the Phase III FIBRONEER-ILD study.
Monday’s Phase III win positions nerandomilast as a potential successor to Boehringer’s Ofev (nintedanib), which is also indicated for IPF to slow disease progression. In 2023, Ofev was one of the pharma’s top-performing assets, growing 12.8% year-over-year and bringing in more than $3.9 billion.
