Boehringer Ingelheim’s investigational therapy, BI 1015550, for the treatment of idiopathic pulmonary fibrosis (IPF) was granted Breakthrough Therapy Designation by the FDA. BI 1015550 is an oral, phosphodiesterase 4B (PDE4B) inhibitor with the potential to address both pulmonary fibrosis – an irreversible scarring of lung tissue that negatively impacts lung function – and inflammation associated with progressive fibrosing interstitial lung diseases (ILDs).
 
The efficacy, safety, and tolerability of BI 1015550 was studied in a Phase II randomized, double-blind, placebo-controlled trial of patients with IPF (n=147). The primary endpoint was change from baseline in Forced Vital Capacity (FVC) – a measure of lung function – over a 12-week treatment period. 
 
The FDA Breakthrough Therapy designation is supported by data collected to date. Initiation of the Phase III program is expected later this year.
 
The FDA established the Breakthrough Therapy Designation process to expedite the development and review of drugs for serious or life-threatening conditions where preliminary clinical evidence indicate that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.