FDA grants breakthrough designation to IPF investigational therapy

The FDA has granted breakthrough designation to a novel investigational therapy, BI 1015550, for treatment of patients with idiopathic pulmonary fibrosis, according to a press release from Boehringer Ingelheim.

“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,” Thomas Sec, MD, senior vice president of medicine and regulatory affairs at Boehringer Ingelheim, said in the release.

BI 1015550 is an investigational orally administered phosphodiesterase 4B (PDE4B) inhibitor that may address pulmonary fibrosis and the inflammation associated with progressive fibrosing ILDs. This therapy was studied as a monotherapy and combined with other antifibrotic therapies to evaluate its effectiveness in slowing lung function decline in patients with IPF.

“BI 1015550 represents the first molecule in the class of PDE4B inhibitors that is being studied for IPF and other progressive fibrosing ILDs,” Sec said. “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.”

This breakthrough designation is supported by efficacy and safety data demonstrated in a phase 2 randomized, double-blind, placebo-controlled trial that will be presented at the 2022 American Thoracic Society International Conference in May.