Boehringer Ingelheim has shared new phase 2 data for BI 1015550 – a novel investigational oral phosphodiesterase 4B (PDE4B) inhibitor – that has been published in The New England Journal of Medicine (NEJM).
The 12-week data showed a significant reduction in the rate of lung function decline in patients diagnosed with idiopathic pulmonary fibrosis (IPF) receiving BI 1015550, compared with patients receiving placebo (both with or without background approved antifibrotics).
Idiopathic pulmonary fibrosis (IPF) is regarded as being one of the more common types of progressive fibrosing interstitial lung diseases. IPF affects an estimated 3 million people globally, including around 32,500 in the UK. The condition typically affects those over the age of 50 and is known to affect more men than women.
Symptoms of IPF can include breathlessness during activity, a dry and persistent cough, chest discomfort, fatigue and weakness.
“This 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 Luca Richeldi, Professor of respiratory medicine at the Università Cattolica del Sacro Cuore in Rome, Italy and the principal investigator on the trial.
The trial also met its secondary endpoint, demonstrating that BI 1015550 showed acceptable safety and tolerability in IPF patients after 12 weeks.
The results will be presented at the American Thoracic Society (ATS) International Conference Breaking News session on 16 May in San Francisco.
In February 2022, the treatment was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA).
Boehringer Ingelheim will begin a phase 3 clinical trial programme to continue investigating if BI 1015550 improves lung function in people with IPF and other forms of progressive pulmonary fibrosis.