Boehringer Ingelheim announced results from the Phase 3 INPULSIS-1 and -2 trials for nintedanib being studied in people with idiopathic pulmonary fibrosis (IPF). Nintedanib is a small molecule tyrosine kinase inhibitor (TKI) which targets growth factors that may be involved in pulmonary fibrosis, such as the vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), and platelet-derived growth factor receptor (PDGFR).

The double-blind, randomized and placebo-controlled trials evaluated the effect of oral nintedanib, 150mg twice daily, on annual rate of decline in forced vital capacity forced vital capacity (FVC), in people with IPF over 52 weeks. A total of 1,061 (n=638, nintedanib vs. 423, placebo) people with IPF were enrolled in the two trials, including 513 people in INPULSIS-1 (n=309, nintedanib vs. 204, placebo) and 548 in INPULSIS-2 (n=329, nintedanib vs. n=219, placebo). The trials had an identical design, matched dosing, inclusion criteria, and endpoints. The primary endpoint was the annual rate of decline in FVC (expressed in mL over 52 weeks).

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INPULSIS™-1 and -2 met the primary endpoint of reduction in the annual rate of decline in FVC over 52 weeks. In these trials, nintedanib reduced the annual rate of FVC decline compared to placebo by 48% in INPULSIS-1 (-114.7 vs. -239.9 mL/year, respectively [95% CI: 77.7, 172.8]) and by 55% in INPULSIS-2 (-113.6 vs. -207.3 mL/year, respectively [95% CI: 44.8, 142.7]).

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