FDA Grants Breakthrough Therapy Designation for IPF Treatment

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for BI 1015550, a novel investigational therapy for the treatment of patients with idiopathic pulmonary fibrosis (IPF).

The oral, phosphodiesterase 4B (PDE4B) inhibitor is being developed by Boehringer Ingelheim Pharmaceuticals as a potential drug to address both pulmonary fibrosis and inflammation associated with progressive fibrosing interstitial lunch diseases (ILDs).

BI 1015550 was investigated as both a monotherapy and a combination therapy with background antifibrotic therapies to assess the effectiveness of slowing the rate of lung function decline in patients with IPF.

The FDA designation was based on the results of a phase 2 randomized, double-blind, placebo-controlled trial involving 147 patients with IPF. While the full results of the study are going to be presented at the American Thoracic Society (ATS) 2022 meeting on May 16, the FDA designation is based on the data collected to date.

"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, in a statement. "BI 1015550 represents the first molecule in the class of PDE4B inhibitors that is being studied for IPF and other progressive fibrosing ILDs. We have built on our heritage in pulmonary fibrosis and are acting on the breakthrough designation and clinical data with the goal that this potential novel medicine can reach patients as soon as possible."