Boehringer Ingelheim announces nintedanib trial met its primary endpoint

1st October 2019 (Last Updated December 23rd, 2019 12:10)

Boehringer Ingelheim has presented data that shows the Phase III INBUILD trial of nintedanib met its primary endpoint.

Boehringer Ingelheim has presented data that shows the Phase III INBUILD trial of nintedanib met its primary endpoint.

The drug was evaluated for its efficacy and safety over 52 weeks in patients with a broad range of progressive fibrosing interstitial lung diseases other than idiopathic pulmonary fibrosis (IPF).

Nintedanib is an antifibrotic drug approved in over 70 countries to treat IPF. It received approval in the US last month for patients with systemic sclerosis-associated interstitial lung disease (ILD).

Boehringer Ingelheim chief medical officer Dr Mehdi Shahidi said: “We are very proud to be presenting the results of this first ever clinical trial studying patients with different forms of progressive fibrosing ILDs, which are the basis of the regulatory applications that were recently submitted with the FDA and EMA.

“We are absolutely committed to improving the lives of people living with pulmonary fibrosis, in particular those affected by rare diseases with a high level of unmet need.”

Data has been published in the New England Journal of Medicine and will be presented at the ERS Congress in Madrid, Spain.

INBUILD is a randomised, double-blind, placebo-controlled, parallel-group trial that saw the participation of 663 patients. It was conducted at 153 sites in 15 countries.

The primary endpoint was the annual rate of decline in FVC, a lung function test, over 52 weeks. The drug slowed lung function decline by 57% with a rate of -80.8 mL/year.

INBUILD trial lead investigator professor Kevin Flaherty said: “Progressive fibrosis of the lung can have a devastating impact on patients with a range of conditions. Yet, except for IPF and the new approved therapy for use in SSc-ILD in the US, there are currently no medications approved for the treatment of progressive fibrosing ILDs.

“The results of INBUILD showed for the first time that nintedanib slowed the decline of lung function in patients with a range of fibrosing lung diseases, who demonstrate a progressive phenotype, across a spectrum of ILD diagnoses.”