Boehringer Ingelheim’s investigational therapy for idiopathic pulmonary fibrosis (IPF) has shown positive data in a Phase II clinical trial, the company has announced.
The company is investigating its oral phosphodiesterase 4B (PDE4B) inhibitor (BI 1015550) as a potential treatment for people with IPF.
In a Phase II study of 147 patients, those receiving BI 1015550 showed a reduction in the rate of lung function decline compared to those receiving a placebo.1
The trial met both its primary and secondary endpoint. Its primary endpoint was the change from baseline in forced vital capacity (FVC; the maximum amount of air, measured in mL, that can be forcibly exhaled from the lungs after fully inhaling). At week 12, patients on BI 1015550 and who were not on approved antifibrotics saw a change of +5.7mL compared to -81.7mL for those on a placebo. In patients already taking antifibrotic therapy, the median changes in FVC were +2.7 mL for BI 1015550 and -59.2 mL in the placebo arm.
For its secondary endpoint, BI 1015550 also demonstrated acceptable safety and tolerability in IPF patients over 12 weeks.
BI 1015550 was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) in February 2022. Boehringer Ingelheim will be initiating a Phase III clinical trial programme to further investigate if BI 1015550 improves lung function in people with IPF and other forms of progressive pulmonary fibrosis.
“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,” commented Luca Richeldi, Professor of Respiratory Medicine at the Università Cattolica del Sacro Cuore in Rome, Italy, and the Principal Investigator on the trial.
“As the global market leader in pulmonary fibrosis, we have the ambition to go beyond slowing down disease progression and hope to one day provide a cure for this chronic debilitating condition,” said Carinne Brouillon, Member of the Board of Managing Directors and Head of Human Pharma, Boehringer Ingelheim. “The Phase II results reinforce our confidence in BI 1015550 which will be accelerated into a pivotal Phase III programme. 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.”
1 Richeldi L., et al. Safety and Efficacy of BI 1015550, a Preferential Inhibitor of Phosphodiesterase 4B, in Patients with Idiopathic Pulmonary Fibrosis: a Phase 2 Trial. Presented at American Thoracic Society (ATS) International Conference Breaking News session on May 16 2022.