Promising 12-week Phase II trial data with BI 1015550, a novel investigational phosphodiesterase 4B (PDE4B) inhibitor, published in The New England Journal of Medicine
Potential new treatment for progressive pulmonary fibrosis (PPF) builds on Boehringer Ingelheim’s leadership in lung fibrosis and will be further investigated in a Phase III clinical trial program
New treatments are needed to complement existing therapies and to help stop, rather than slow, disease progression
(BUSINESS WIRE) -- Today, Boehringer Ingelheim announced Phase II data for BI 1015550, a novel investigational phosphodiesterase 4B (PDE4B) inhibitor, that was published in The New England Journal of Medicine (NEJM). The promising 12-week data that showed a reduction in the rate of lung function decline in patients with idiopathic pulmonary fibrosis (IPF) will also be presented at the American Thoracic Society (ATS) International Conference Breaking News session on May 16 in San Francisco.1
“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.
The primary endpoint of the trial was the change from baseline in forced vital capacity (FVC) – meaning the maximum amount of air (measured in mL) that can be forcibly exhaled from the lungs after fully inhaling – at week 12. Median changes for patients taking BI 1015550 showed a slight improvement in FVC, and in those who took placebo, FVC was reduced:1
The median changes in FVC in patients who were not on approved antifibrotics were +5.7 mL for BI 1015550 and -81.7 mL for 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.
There is >98% probability that BI 1015550 was superior to placebo in slowing down the worsening of lung function in people with IPF.
“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 program. 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,1 demonstrating that BI 1015550 showed acceptable safety and tolerability in IPF patients 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.
BI 1015550 was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) in February 2022. Boehringer Ingelheim will be initiating a Phase III clinical trial program to further investigate if BI 1015550 improves lung function in people with IPF and other forms of PPF, with the ambition to bring this medicine to patients as soon as possible.
About the trial
The Phase II randomized, double-blind, placebo-controlled study (NCT04419506) investigated the efficacy and safety of oral BI 1015550, 18 mg twice daily, in patients with IPF (n=147)
Patients with FVC ≥45% predicted, who were either not on antifibrotic therapy or were on a stable dose of antifibrotic therapy for at least 8 weeks before study entry, were randomized 2:1 to receive either BI 1015550 18 mg twice daily or placebo for 12 weeks
The primary endpoint was change in baseline in FVC at week 12 and the secondary endpoint was the proportion of patients with treatment-emergent adverse events during the trial
Initiation of the Phase III program is expected later this year:
NCT05321082: in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
NCT05321069: in patients with IPF
Please click on the link for ‘Notes to Editors’ and ‘References’: https://www.boehringer-ingelheim.com/human-health/lung-diseases/pulmonary-fibrosis/investigational-treatment-slowed-lung-function
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