The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to BI 1015550 for the treatment of idiopathic pulmonary fibrosis (IPF).

BI 1015550 is an investigational oral phosphodiesterase 4B (PDE4B) inhibitor. The Company believes that BI 1015550 will be able to address both pulmonary fibrosis and inflammation associated with progressive fibrosing interstitial lung diseases (ILDs).

The designation is supported by data from a randomized, double-blind, placebo-controlled phase 2 trial ( Identifier: NCT04419506) that evaluated the efficacy and safety of BI 1015550 as monotherapy or in combination with background antifibrotic therapy in 147 adults with IPF. The primary endpoint was the change from baseline in Forced Vital Capacity (FVC) over a 12-week period.

Results from the phase 2 study will be presented at the American Thoracic Society (ATS) 2022 session in San Francisco, CA on Monday, May 16, 2022. The Company expects to initiate a phase 3 program for BI 1015550 later this year.

“The accelerated development of BI 1015550 is part of Boehringer Ingelheim’s next wave of potential innovative treatments for interstitial lung diseases aimed at preserving lung function and improving the lives of patients,” said Thomas Seck, MD, senior vice president, Medicine and Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “BI 1015550 represents the first molecule in the class of PDE4B inhibitors that is being studied for IPF and other progressive fibrosing ILDs.”  


FDA grants BI 1015550 Breakthrough Therapy designation for idiopathic pulmonary fibrosis. News release. Boehringer Ingelheim Pharmaceuticals. Accessed February 24, 2022.