Boehringer Ingelheim gets USFDA Breakthrough Therapy Designation for BI 1015550
Germany: Boehringer Ingelheim has announced that the U.S. Food and Drug Administration (USFDA) has 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."
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.
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