Boehringer Ingelheim has reported encouraging 12-week phase 2 trial data on their investigational BI 1015550 therapy, a novel phosphodiesterase 4B inhibitor for patients with idiopathic pulmonary fibrosis (IPF).

The results, reported via news release, were presented at the American Thoracic Society (ATS) International Conference breaking news session in San Francisco, California on May 16, 2022.

“These encouraging, early data showed that treatment with BI 1015550 slowed the rate of lung function decline in patients who were not on approved antifibrotics, as well as those who were taking existing antifibrotic therapy,” said Luca Richeldi, the principal investigator of the trial from the Università Cattolica del Sacro Cuore in Rome, Italy.


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Since February 2022, BI 1015550 has had Breakthrough Therapy designation from the US Food and Drug Administration. The phase 2 trial showed a significant reduction in the rate of lung function decline as measured by the primary endpoint, change from baseline in forced vital capacity (FVC) at week 12. Patients on BI 1015550 showed a slight improvement in FVC, while those given a placebo showed a decline in FVC.

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In terms of the safety and tolerability of secondary endpoints, BI 1015550 performed well over the 12-week period. The most common adverse event (AE) was diarrhea, and none of the AEs reported were serious. No new safety issues were identified.

A phase 3 clinical trial will be initiated later this year to further assess the ability of BI 1015550 to improve lung function in patients with IPF and patients with progressive fibrosing interstitial lung disease.

Reference

Boehringer Ingelheim’s latest investigational treatment slowed lung function decline in people living with idiopathic pulmonary fibrosis. News release. Boehringer Ingelheim; May 15, 2022.