Phase II data for BI 1015550, a novel investigational phosphodiesterase 4B inhibitor, 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.

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: i. 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. ii. 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. iii. There is greater than 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, 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 ( greater than 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 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.

See-

"Trial of a Preferential Phosphodiesterase 4B Inhibitor for Idiopathic Pulmonary Fibrosis"_Luca Richeldi, M.D., Ph.D., Arata Azuma, M.D., Ph.D., Vincent Cottin, M.D., Ph.D., et al. for the 1305-0013 Trial Investigators.May 15, 2022 DOI: 10.1056/NEJMoa2201737.