As an eagerly-anticipated debate kicks off at the American Thoracic Society conference in San Diego on drugs for idiopathic pulmonary fibrosis, Boehringer Ingelheim has posted promising late-stage data on its offering, nintedanib.
The company has published data from the two Phase III INPULSIS trials involving 1,066 patients, showing that nintedanib met its primary endpoint of slowing disease progression. Specifically, the drug significantly reduced the annual decline in forced vital capacity (FVC) by some 50% compared to patients taking placebo over 52 weeks.
Both key secondary endpoints were met in the INPULSIS-2 trial, namely significantly less deterioration in quality of life and a reduced risk of a first acute exacerbation in patients taking nintedanib, compared to placebo. Study investigator Luca Richeldi of the University of Southampton said the latter is of particular clinical importance, because unlike with chronic obstructive pulmonary disease, "acute exacerbations are rapid and unexplained episodes of deterioration in IPF [which] can lead to death in approximately half of the patients.” In INPULSIS-1, however, there was no statistically significant difference between the nintedanib and placebo groups in the key secondary endpoints.
Prof Richeldi told PharmaTimes here in San Diego that he is very impressed by the data "as most trials before this were negative or showed increased mortality in the treatment arm". He added that "for the very first time we see two massive trials providing exactly the same results over one year", highlighting the global reach of the studies (including India, China, Europe and North and South America) and the fact that the results were "remarkably similar" to those seen in Phase II.
Charles de Wet, Boehringer's UK medical director, said "we are delighted that these latest Phase III results show benefits for patients with this devastating disease", adding that "we have a long heritage in the respiratory arena".
The nintedanib data will be presented during the New England Journal of Medicine and the Journal of the American Medical Association here at the ATS (10pm UK time). The meeting room will be packed for the session as data from InterMune's ASCEND study on its IPF drug Esbriet (pirfenidone) will also be presented and there will be a discussion on the merits of the two treatments (analysis on PharmaTimes to follow).