FDA Grants BI 1015550 Breakthrough Therapy Designation for Idiopathic Pulmonary Fibrosis

RIDGEFIELD, Conn. and INGELHEIM, Germany, Feb. 24, 2022 /PRNewswire/ -- Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to its novel investigational therapy, BI 1015550, for the treatment of idiopathic pulmonary fibrosis (IPF). 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 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, M.D., 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. 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."  

About BI 1015550
BI 1015550 is an investigational, oral, phosphodiesterase 4B (PDE4B) inhibitor with combined antifibrotic and anti-inflammatory effects. BI 1015550 was studied as a monotherapy or in combination with background antifibrotic therapy to assess the effectiveness of slowing the rate of lung function decline in patients with IPF (NCT04419506).

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 results from the Phase II study will be presented at the American Thoracic Society (ATS) 2022 session titled BREAKING NEWS: CLINICAL TRIAL RESULTS IN PULMONARY MEDICINE in San Francisco, CA on Monday, May 16.

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. 

About IPF and ILDs
IPF is one of the more common progressive fibrosing ILDs. Symptoms of IPF include breathlessness during activity, a dry and persistent cough, chest discomfort, fatigue and weakness. Although considered "rare," IPF affects approximately 3 million people worldwide. The disease primarily affects patients over the age of 50 and affects more men than women.

ILDs encompass more than 200 disorders that can lead to pulmonary fibrosis – an irreversible scarring of lung tissue that negatively impacts lung function and may become life-threatening.

About Boehringer Ingelheim  
Boehringer Ingelheim is working on breakthrough therapies that improve the lives of humans and animals. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Around 52,000 employees serve more than 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing.  

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation and is part of the Boehringer Ingelheim group of companies.  In addition, there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont, Inc. in Fremont, CA. 

Boehringer Ingelheim is committed to improving lives and strengthening our communities. Please visit www.boehringer-ingelheim.us/csr to learn more about Corporate Social Responsibility initiatives. 

For more information, please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS. 

Media Contact: Susan Holz, [email protected], 203.798.4265

SOURCE Boehringer Ingelheim Pharmaceuticals