Boehringer aims to obtain approval for a pulmonary fibrosis drug after successful completion of Phase III

Boehringer's nerandomilast is a preferred inhibitor of phosphodiesterase 4B (PDE4B). Image credit: Tada Images / Shutterstock.

Boehringer Ingelheim is seeking regulatory approval for nerandomilast after a Phase III study in idiopathic pulmonary fibrosis (IPF) met its primary endpoint.

Boehringer confirmed that the Phase III FIBRONEER-IPF study (NCT05321069) met its primary endpoint of improvement in forced vital capacity, a measure of lung function, after 52 weeks. The company plans to present full efficacy and safety data from the study in the first half of 2025.

Boehringer was quick to point out that the Phase III study of nerandomilast was the first late-stage IPF study in ten years to meet its primary goal. This is not the first time Boehringer has achieved success in this area.

Its tyrosine kinase inhibitor (TKI) Ofev (nintedanib) was approved by the U.S. Food and Drug Administration (FDA) in 2014 to treat IPF. It has since been approved in the U.S. for interstitial lung disease associated with systemic sclerosis or scleroderma (SSc-ILD) and chronic interstitial lung disease. Ofev has also brought record profits to Boehringer, with the therapy generating global sales of €3.5 billion ($3.89 billion) last year.

The Phase III FIBRONEER-IPF trial enrolled 1,177 patients with IPF who were randomized to receive either nerandomilast or placebo twice daily. The secondary endpoint of the trial is time to first acute IPF exacerbation, first respiratory hospitalization, or death.

Nerandomilast is a preferred inhibitor of phosphodiesterase 4B (PDE4B). The US FDA designated nerandomilast as a breakthrough therapy for the treatment of IPF in 2022. Boehringer is also investigating nerandomilast in patients with progressive fibrosing interstitial lung disease in a Phase III FIBRONEER-ILD study (NCT05321082), which is expected to be completed by the end of the year.

Access the most comprehensive company profiles on the market, powered by GlobalData. Save hours of research. Gain a competitive advantage.

Company profile – free sample

Your download email will arrive shortly

We are confident in the unique quality of our company profiles, but we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by filling out the form below.

By GlobalData

Check this box to stop receiving curated industry news, reports and event updates from Pharmaceutical Technology.

For more information about our Services, how we use, process and share your personal data, including information about your rights in relation to your personal data and how to unsubscribe from future marketing communications, please see our Privacy Policy. Our Services are aimed at corporate subscribers and you warrant that the email address provided is your corporate email address.

There is a high unmet need for IPF because there are only two drugs approved by the U.S. FDA: Ofev and Roche's Esbriet (pirfenidone). Although Roche's TGF-beta synthesis inhibitor also received FDA approval in 2014, the company's profits have declined due to the introduction of generics. According to Roche's financials, the drug generated sales of 718 million Swiss francs ($752 million) in 2022, while sales fell to 202 million Swiss francs ($239 million) last year.

Most other therapies being developed for IPF are in Phase II clinical trials. In May, Vicore Pharma's Phase IIa study of the angiotensin II type 2 receptor (AT2R) agonist buloxibutide in IPF met both its primary and secondary endpoints. Bridge Biotherapeutics' Phase II study evaluating its autotoxin inhibitor BBT-877 in IPF is expected to deliver topline data in the first half of 2025.