German pharma giant Boehringer Ingelheim announced positive topline results from the Phase III FIBRONEER-ILD study of its investigational phosphodiesterase 4B (PDE4B) inhibitor nerandomilast, demonstrating a statistically significant improvement in forced vital capacity (FVC) at week 52 versus placebo in patients with progressive pulmonary fibrosis (PPF).
Study Details
The trial met its primary endpoint, showing nerandomilast slowed lung function decline in PPF patients. The FIBRONEER global program includes two Phase III studies: FIBRONEER-IPF (idiopathic pulmonary fibrosis) and FIBRONEER-ILD (PPF). Results will support a new drug application (NDA) in the U.S., where nerandomilast received Breakthrough Therapy Designation (BTD) in February 2022.
Drug Profile
Nerandomilast, an oral PDE4B inhibitor, is not yet approved. It is designed to reduce inflammation and fibrosis in PPF. The drug’s safety and efficacy are under evaluation in the FIBRONEER trials.
Strategic Outlook
Boehringer plans to leverage the Phase III data for regulatory filings worldwide. The BTD status in the U.S. could accelerate approval, positioning nerandomilast as a potential first-in-class therapy for PPF.-Fineline Info & Tech
