Boehringer Ingelheim’s IPF Drug Shines in Phase III Trials

Boehringer Ingelheim said its experimental lung-disease drug nintedanib significantly slowed disease progression in the company’s Phase III INPULSIS trials.

The two Phase III trials of 1,061 patients with idiopathic pulmonary fibrosis (IPF) met the primary endpoint of reduction in annual rate of lung function decline, the company said. Nintednab is the first targeted treatment for IPF to consistently meet this endpoint in two identical Phase III trials.

IPF is a debilitating and fatal lung disease, for which there are few treatment options. Patients have a median survival of 2-3 years after diagnosis. It causes progressive scarring of the lungs, resulting in continual and permanent 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, the company explained. The INPULSIS trials measured the reduction in the annual rate of decline in FVC over 52 weeks.

Boehringer said that compared to placebo, nintedanib reduced the annual rate of FVC decline by 48 percent in the INPULSIS-1 trial and by 55 percent in the INPULSIS-2 trial. The placebo only managed a 5 percent reduction, the company said.

"IPF is a very serious disease for which there are currently no FDA-approved treatments," said study investigator Luca Richeldi, professor of respiratory medicine and chair of interstitial lung disease at the University of Southampton, UK.  “There is a high unmet need for effective treatments that can specifically alter the course of this deadly disease by slowing disease progression," he said.

These results are groundbreaking, as current IPF therapies only blunt the symptoms of the disease, rather than change its deadly trajectory.  — Kellen Owings

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