Boehringer’s nintedanib slows IPF disease progression in Ph III trial

Results from the Phase III INPULSIS trials, published on-line yesterday in the New England Journal of Medicine, show that German family-owned drug major Boehringer Ingelheim’s cancer drug candidate nintedanib significantly slowed disease progression in patients with idiopathic pulmonary fibrosis (IPF).

Nintedanib is the first targeted treatment for IPF to consistently meet the primary endpoint in two international Phase III trials with identical design, noted the company which also presented that data at the American Thoracic Society conference. InterMune also released new data on its pirfenidone in patients with IPF (see separate story today). #

IPF is a debilitating and fatal lung disease, with a median survival of two to three years after diagnosis. It causes progressive scarring of the lungs, resulting in continual and irreversible deterioration in lung function and difficulty breathing. The average IPF patient has a lung function loss, measured by forced vital capacity (FVC), of 150–200mL per year.

In the two 52 week INPULSIS trials, involving 1,066 patients, nintedanib significantly reduced the annual decline in FVC by around 50% compared to patients taking placebo. The annual rate of FVC decline in the two trials was: