Boehringer Ingelheim announced that its novel investigational therapy for idiopathic pulmonary fibrosis (IPF) received Breakthrough Therapy designation from the US Food and Drug Administration (FDA).

The designation, announced via news release, is based on the results of a phase 2 randomized, double-blind, placebo-controlled trial on 147 patients with IPF. The trial assessed changes from baseline in lung function as measured by forced vital capacity over a 12-week period.

The results of the trial will be presented on May 16th at the American Thoracic Society 2022 in San Francisco, CA, and a phase 3 trial is planned for later in 2022.


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“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 Seck, MD, senior vice president of Boehringer Ingelheim said.

“BI 1015550 represents the first molecule in the class of [phosphodiesterase 4B] inhibitors that is being studied for IPF and other progressive fibrosing [interstitial lung diseases]. 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.”

The Breakthrough Therapy designation is intended to facilitate the development of treatments for life-threatening or serious diseases in which there is preliminary evidence of a significant improvement over current therapies.

BI 1015550 is a phosphodiesterase 4B inhibitor for oral administration. It has anti-inflammatory and antifibrotic effects, and its efficacy in slowing the decline in lung function, safety, and tolerability has been studied as both monotherapy and in combination with other antifibrotic therapies.

Reference

FDA Grants BI 1015550 breakthrough therapy designation for idiopathic pulmonary fibrosis. News release. Beoehringer Ingleheim; February 24, 2022.