Boehringer begins enrolment in Phase III trial of nintedanib for fibrosing lung diseases
US-based Boehringer Ingelheim Pharmaceuticals has begun patient enrolment in the Phase III progressive fibrosing interstitial lung disease (PF-ILD) clinical trial of nintedanib to treat various progressive fibrosing lung diseases, excluding idiopathic pulmonary fibrosis (IPF).
Marketed as Ofev, nintedanib is a kinase inhibitor currently approved for the treatment of IPF.
The randomised, double-blind, placebo-controlled Phase III trial will enrol a total of 600 patients at approximately 60 sites in the country.
The trial will assess the safety and efficacy of 150mg of nintedanib over a period of 52 weeks in patients with established lung fibrosis by chest imaging, which is getting worse in terms of symptoms, physiology or imaging, even after treatment.
Boehringer Ingelheim chief medical officer Christopher Corsico said: "Boehringer Ingelheim is dedicated to advancing the understanding of fibrosing lung diseases where no or limited treatments exist.
"Our innovative PF-ILD trial is designed to include patients with fibrosing lung diseases who would not otherwise be eligible to participate in a clinical trial."
The trial's primary endpoint is the measure of disease progression as an annual rate of decline in forced vital capacity (FVC), while the secondary endpoints include time to first ILD exacerbation and overall survival.
The trial will also determine the absolute change from baseline in the king's brief interstitial lung disease questionnaire (K-BILD).
Ofev has obtained the US Food and Drug Administration (FDA) for IPF on 15 October 2014, based on a clinical trial progamme that investigated the product in more than 1,200 patients.
The programme included the randomised, double-blind, placebo-controlled Phase II TOMORROW trial, as well as the Phase III INPULSIS1 and INPULSIS2 trials.