Boehringer's nintedanib meets in Phase III IPF trials
Boehringer Ingelheim GmbH (Ingelheim, Germany) said twice-daily oral nintedanib ( BIBF 1120) met the primary endpoint of reducing the annual rate of decline in forced vital capacity (FVC) vs. placebo in a pair of identical, double-blind, international Phase III trials to treat idiopathic pulmonary fibrosis (IPF). In INPULSIS-1 (n=513), nintedanib missed the secondary endpoints of reducing deterioration in St. George's Respiratory Questionnaire (SGRQ) total score at week 52 and of improving time to first acute exacerbation vs. placebo. In INPULSIS-2 (n=548), nintedanib met both secondary endpoints vs. placebo. Data are slated to be presented at the American Thoracic Society meeting in May. Boehringer did not provide next steps for nintedanib in the indication in time for publication. ...