IPF Drug Meets Primary End Point - Managed Healthcare Executive
Boehringer Ingelheim's nerandomilast met primary endpoint in phase 3 trial for idiopathic pulmonary fibrosis (IPF), marking the first successful IPF phase-3 trial in a decade. The oral drug, a preferential inhibitor of phosphodiesterase 4B, received FDA breakthrough therapy designation in 2022. Boehringer plans to submit a new drug application to the FDA and other regulators based on these positive results.
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Boehringer Ingelheim's nerandomilast met primary endpoint in phase 3 trial for idiopathic pulmonary fibrosis (IPF), marking the first successful IPF phase-3 trial in a decade. The oral drug, a preferential inhibitor of phosphodiesterase 4B, received FDA breakthrough therapy designation in 2022. Boehringer plans to submit a new drug application to the FDA and other regulators based on these positive results.
Boehringer Ingelheim and Insilico Medicine reported positive data from their idiopathic pulmonary fibrosis (IPF) drug trials, indicating potential to stop or reverse lung function decline. Boehringer's nerandomilast showed significant FVC improvement in a Phase III trial, while Insilico's ISM001-055 demonstrated dose-dependent FVC improvement in a Phase IIa trial. Both companies await further data and regulatory feedback.
Boehringer Ingelheim's nerandomilast met primary endpoint in Phase III FIBRONEER-IPF study, significantly improving lung function in IPF patients. The drug targets PDE4B enzyme to exert anti-fibrotic and anti-inflammatory effects. Boehringer plans to use study results for FDA and global regulatory submissions, with full data expected in H1 2025.
Phase 3 FIBRONEER-IPF trial met primary endpoint with nerandomilast in adults with IPF, showing absolute change in FVC. Boehringer Ingelheim plans to submit a new drug application to the FDA and present full findings in early 2025.
Boehringer Ingelheim's investigational drug, nerandomilast, met the primary endpoint in the phase 3 FIBRONEER-IPF trial, marking the first success in a decade for treating idiopathic pulmonary fibrosis (IPF). The trial showed improved lung function based on absolute change in forced vital capacity (FVC) at week 52 compared to placebo. Boehringer Ingelheim plans to submit a new drug application for nerandomilast, which could offer a novel treatment option for IPF, currently limited to nintedanib and pirfenidone.
The FIBRONEER-ON trial aims to assess the extended safety and long-term efficacy of neradomilast in IPF and PPF patients. A Phase 2b trial with admilparant, an LPA1 antagonist, showed the 60-mg dose slowed FVC decline in both IPF and PPF groups, leading to Phase 3 trials.