15 May Lung Disease: In Clinical Trial New Boehringer Ingelheim Drug Prevented Worsening of IPF
MedicalResearch.com Interview with:
Professor Luca Richeldi MD PhD
Chair and Head, Division of Pulmonary Medicine
Gemelli University Hospital – IRCCS
Catholic University of the Sacred Heart
MedicalResearch.com: What is the background for this study? Would you briefly explain the condition of Idiopathic Pulmonary Fibrosis?
Response: As you may know, Idiopathic pulmonary fibrosis (IPF) is a progressive, irreversible lung disease with high mortality. IPF is one of the more common forms of progressive fibrosing interstitial lung diseases and its symptoms of IPF include breathlessness during activity, a dry and persistent cough, chest discomfort, fatigue and weakness. IPF is considered a “rare” disease, but it affects more than 3 million people worldwide. Currently, there are two approved antifibrotic drugs that slow, but do not stop, the progression of fibrosis. Therefore, there is a need for additional treatments that can be used alone or with existing antifibrotic therapies.
Pre-clinical research indicated that phosphodiesterase 4 (PDE4) inhibition is associated with anti-inflammatory and antifibrotic effects that may be beneficial in patients with idiopathic pulmonary fibrosis.
In this Phase 2, double-blind, placebo-controlled trial, we investigated the efficacy and safety of BI 1015550, an oral preferential inhibitor of the PDE4B subtype, in patients with IPF. Patients were randomly assigned in a 2:1 ratio to receive BI 1015550 at a dose of 18 mg twice daily or placebo.
MedicalResearch.com: What are the main findings?
Response: The primary endpoint was the change from baseline in the forced vital capacity (FVC) at 12 weeks, which we analyzed with a Bayesian approach separately according to background nonuse or use of an antifibrotic agent.
Median changes for patients taking BI 1015550 showed a slight improvement in FVC, and in those who took placebo, FVC was reduced:
- The median changes in FVC in patients who were not on approved antifibrotics were +5.7 mL for BI 1015550 and -81.7 mL for placebo.
- In patients already taking antifibrotic therapy, the median changes in FVC were +2.7 mL for BI 1015550 and -59.2 mL in the placebo arm.
- There is >98% probability that BI 1015550 was superior to placebo in slowing down the worsening of lung function in people with IPF.
MedicalResearch.com: What should readers take away from your report?
Response: In this placebo-controlled trial, treatment with BI 1015550, either alone or with background use of an antifibrotic agent, prevented a decrease in lung function in patients with IPF.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: A Phase III trial is needed to further investigate if BI 1015550 improves lung function in people with IPF. Additionally, there remains an unmet need for additional research to investigate potential treatments that may help reverse the progression of this disease and potentially reduce the mortality rate.
Disclosures: This trial was supported and funded by Boehringer Ingelheim (NCT04419506
Trial of a Preferential Phosphodiesterase 4B Inhibitor for Idiopathic Pulmonary Fibrosis Luca Richeldi, M.D., Ph.D., Arata Azuma, M.D., Ph.D., Vincent Cottin, M.D., Ph.D., Christian Hesslinger, Ph.D., Susanne Stowasser, M.D., Claudia Valenzuela, M.D., Marlies S. Wijsenbeek, M.D., Ph.D., Donald F. Zoz, M.D., Florian Voss, Ph.D., and Toby M. Maher, M.D., Ph.D., for the 1305-0013 Trial Investigators*
NEJM: May 15, 2022
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