Trial of a Preferential Phosphodiesterase 4B Inhibitor for Idiopathic Pulmonary Fibrosis

Richeldi, Luca; Azuma, Arata; Cottin, Vincent; Heßlinger, Christian; Stowasser, Susanne; Valenzuela, Claudia; Wijsenbeek, Marlies; Zoz, Donald F.; Voß, Florian; Maher, Toby M.

doi:10.1056/nejmoa2201737

Cited by 121 publications

(82 citation statements)

References 25 publications

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“…This precluded investigation of potential additive effects on the efficacy and/or safety of BI 1015550 in combination with background antifibrotic standard of care. Such effects are, however, being investigated in a phase II study of BI 1015550 in patients with IPF with and without background antifibrotic treatment, which has recently completed ( www.clinicaltrials.gov identifier number NCT04419506) [ 18 ].…”

Section: Discussionmentioning

confidence: 99%

Phase I studies of BI 1015550, a preferential phosphodiesterase 4B inhibitor, in healthy males and patients with idiopathic pulmonary fibrosis

et al. 2022

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IntroductionBI 1015550 is a phosphodiesterase 4 (PDE4) inhibitor that has antifibrotic properties. Phase I and Ic studies were conducted to investigate the safety, tolerability and pharmacokinetics of BI 1015550 in healthy males and patients with idiopathic pulmonary fibrosis (IPF).MethodsIn the Phase I study, 42 subjects were partially randomised to receive placebo or BI 1015550 in single rising doses of 36 mg and 48 mg, or multiple rising doses of 6 mg and 12 mg twice daily over 14 days. In the Phase Ic study, 15 patients with IPF were randomised to receive 18 mg BI 1015550 or placebo twice daily for up to 12 weeks. For both studies, the primary endpoint was the number of subjects with drug-related adverse events (AEs).ResultsIn the Phase I study, drug-related AEs were reported for 50.0% of healthy males treated with a single dose of BI 1015550, compared with 16.7% receiving placebo. For those receiving multiple doses, drug-related AEs were reported for 37.5% of those treated with BI 1015550 and 12.5% receiving placebo. The most frequently reported AEs by organ class were nervous system disorders, which were largely driven by headache. In the Phase Ic study, drug-related AEs were reported in 90.0% of patients treated with BI 1015550, compared with 60.0% of those receiving placebo. The most frequent AEs by organ class were gastrointestinal AEs.ConclusionsBI 1015550 had an acceptable safety profile in healthy males and patients with IPF, supporting further development in larger trials.

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Section: Discussionmentioning

confidence: 99%

Phase I studies of BI 1015550, a preferential phosphodiesterase 4B inhibitor, in healthy males and patients with idiopathic pulmonary fibrosis

et al. 2022

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“…Data on pharmacological treatment for IIPs were also presented at the congress. Preferential inhibition of phosphodiesterase 4B (PDE4B) has emerged as a promising molecule in IPF 8 . A post hoc analysis of the BI 1015550 phase 2 study suggested it may have more pronounced effects if taken with nintedanib than with pirfenidone on preventing FVC decline in patients with IPF 9 .…”

Section: Idiopathic Interstitial Pneumoniasmentioning

confidence: 99%

ERS International Congress 2022: highlights from the Interstitial Lung Diseases Assembly

et al. 2023

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This article contains a selection of scientific highlights in the field of interstitial lung diseases (ILDs) presented at the hybrid European Respiratory Society (ERS) congress 2022. Early Career Members of Assembly 12 summarize recent advances in translational and clinical research in idiopathic interstitial pneumonias, ILDs of known origin, sarcoidosis and other granulomatous diseases, and rare ILDs. Many studies focused on evaluation of diagnostic and prognostic (bio)markers, and novel pharmacological and non-pharmacological treatment options for different ILDs. Besides, new insights in clinical, physiological, and radiological features of various rare ILDs were presented.

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“…A phase 2 double-blind, placebo-controlled trial recruited 147 patients aged over 40 with an existing diagnosis of IPF with or without background antifibrotic treatment and evaluated the efficacy of BI 1015550 over a 12-week period with the primary endpoint being a change in baseline forced vital capacity (FVC) [ 78 ]. Interestingly, in patients without pre-existing antifibrotic use, the median change in FVC was 5.7 mL (95% CI, −39.1 to 50.5) in the BI 1015550 group and −81.7 mL in the placebo group (95% CI, –133.5 to –44.8) whereas in patients with pre-existing anti-fibrotic use, the median change was 2.7 mL (95% credible interval, –32.8 to 38.2) in the BI 1015550 group and −59.2 mL in the placebo group (95% credible interval, –111.8 to –17.9).…”

Section: Novel Treatmentmentioning

confidence: 99%

Trials and Treatments: An Update on Pharmacotherapy for Idiopathic Pulmonary Fibrosis

Thong

McElduff

Henry

2023

Life

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Idiopathic pulmonary fibrosis (IPF) is a chronic and progressive fibrosing interstitial lung disease that occurs predominantly in the older population. There is increasing incidence and prevalence in IPF globally. The emergence of anti-fibrotic therapies in the last decade have improved patient survival though a cure is yet to be developed. In this review article, we aim to summarize the existing and novel pharmacotherapies for the treatment of IPF (excluding treatments for acute exacerbations), focusing on the current knowledge on the pathophysiology of the disease, mechanism of action of the drugs, and clinical trials.

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Trial of a Preferential Phosphodiesterase 4B Inhibitor for Idiopathic Pulmonary Fibrosis

Cited by 121 publications

References 25 publications

Phase I studies of BI 1015550, a preferential phosphodiesterase 4B inhibitor, in healthy males and patients with idiopathic pulmonary fibrosis

Phase I studies of BI 1015550, a preferential phosphodiesterase 4B inhibitor, in healthy males and patients with idiopathic pulmonary fibrosis

ERS International Congress 2022: highlights from the Interstitial Lung Diseases Assembly

Trials and Treatments: An Update on Pharmacotherapy for Idiopathic Pulmonary Fibrosis

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