Boehringer completes enrolment of two Phase III studies of nintedanib

27th September 2012 (Last Updated September 27th, 2012 18:30)

Boehringer Ingelheim Pharmaceuticals has announced the completion of clinical trial enrolment in two Phase III studies evaluating the safety and efficacy of nintedanib (BIBF 1120) for the treament of idiopathic pulmonary fibrosis (IPF).

Boehringer Ingelheim Pharmaceuticals has announced the completion of clinical trial enrolment in two Phase III studies evaluating the safety and efficacy of nintedanib (BIBF 1120) for the treament of idiopathic pulmonary fibrosis (IPF).

Nintedanib is an investigational compound being studied at a twice-daily oral dose.

University of Michigan Health System Department of Internal Medicine, Division of Pulmonary and Critical Care Medicine, associate professor and study investigator Dr Kevin Flaherty said the standard of IPF care is limited to oxygen therapy and, in some patients, lung transplant.

"IPF patients desperately need safe and effective treatments to not only reduce the decline in lung function and eventually decrease mortality, but also to stabilise health-related quality of life and delay or reduce sudden worsening of symptoms, or acute exacerbations," Flaherty said.

The two identical 52-week, double-blind, randomised, placebo-controlled trials with matching twice-daily 150mg dosing, inclusion criteria and endpoints have enrolled a total of 970 patients in 20 countries.

The annual rate of decline in forced vital capacity (FVC), or the volume of air that is expelled into a spirometer following maximum inhalation, is the primary endpoint. Reductions in FVC are reflected in impaired ventilation capacity of the lungs.

The secondary endpoints include health-related quality of life, exacerbations, respiratory mortality, overall survival and on-treatment survival.

Boehringer Ingelheim Respiratory clinical development and medical affairs vice president Dr Tunde Otulana said; "There is a clear need for approved treatments for IPF patients and we look forward to completing the trials and analysing results from the phase III studies."