Novel Investigational Treatment Slows Lung Function Decline in Patients With Idiopathic Pulmonary Fibrosis

There is greater than a 98% probability that BI 1015550 was superior to placebo in slowing down the worsening of lung function in individuals with idiopathic pulmonary fibrosis.

New 12-week, phase 2 trial data with BI 1015550, a novel investigational drug from Boehringer Ingelheim, has found that the treatment slowed the decline in lung function for patients living with progressive pulmonary fibrosis (PPF).

The drug is an investigational phosphodiesterase 4B (PDE4B) inhibitor and the new data was published in The New England Journal of Medicine. The primary endpoint of the trial was the change from baseline in forced vital capacity, defined as the maximum amount of air that can be forcibly exhaled from the lungs after fully inhaling, at week 12.

“These encouraging, early data showed that treatment with BI 1015550 slowed the rate of lung function decline in patients who were not on approved antifibrotics, as well as those who were taking existing antifibrotic therapy,” said principal investigator Luca Richeldi, MD, PhD, in a press release.

The trial investigated the efficacy and safety of oral BI 1015550 18 mg twice daily in patients with idiopathic pulmonary fibrosis (IPF). Researchers randomized patients with FVC greater than or equal to 45%, and who were either not on antifibrotic therapy or were on a stable dose of antifibrotic therapy for at least 8 weeks before study entry.

Median changes for patients taking BI 1015550 demonstrated a slight improvement in FVC and FVC was reduced in those who took the placebo. Specifically, the median changes in FVC among patients who were not on approved antifibrotics increased by 5.7 mL for BI 1015550 and decreased by 81.7 mL for placebo. In patients already taking antifibrotic therapy, the median changes in FVC increased 2.7 mL for BI 1015550 and decreased 59.2 mL in the placebo arm.

Based on these findings, the researchers concluded that there is s greater than 98% probability that BI 1015550 was superior to placebo in slowing down the worsening of lung function in individuals with IPF.

“The phase 2 results reinforce our confidence in BI 1015550, which will be accelerated into a pivotal phase 3 program,” said Carinne Brouillon, PharmD, a member of the board of managing directors and head of human pharma at Boehringer Ingelheim, in the press release. “We will work with regulatory agencies and scientific communities to potentially bring the next generation of treatments to people living with pulmonary fibrosis as quickly as possible.”

The trial also met its secondary endpoint, showing acceptable safety and tolerability in patients with IPF over 12 weeks. Diarrhea was the most frequently reported event in all patients (>10% of patients) and all events were reported as non-serious. No new safety topics were identified, and baseline characteristics were generally balanced across both treatment groups.

The treatment was granted Breakthrough Therapy Designation by the FDA in February 2022 and a phase 3 clinical trial program will be initiated to investigate whether BI 1015550 improves lung function in individuals with IPF and other forms of PPF. One study will investigate the treatment in patients with Progressive Fibrosing Interstitial Lung Disease, and another will investigate it further in patients with IPF.

REFERENCE

Boehringer Ingelheim’s latest investigational treatment slowed lung function decline in people living with idiopathic pulmonary fibrosis. News release. Boehringer Ingelheim; May 15, 2022. Accessed May 17, 2022. https://www.boehringer-ingelheim.com/human-health/lung-diseases/pulmonary-fibrosis/investigational-treatment-slowed-lung-function