Target inhibition of galectin-3 by inhaled TD139 in patients with idiopathic pulmonary fibrosis
Galectin (Gal)-3 is a profibrotic β-galactoside-binding lectin that plays a key role in the pathogenesis of idiopathic pulmonary fibrosis (IPF) and IPF exacerbations. TD139 is a novel and potent small-molecule inhibitor of Gal-3.A randomised, double-blind, multicentre, placebo-controlled, phase 1/2a...
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| Veröffentlicht in: | The European respiratory journal Jg. 57; H. 5 |
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01.05.2021
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| Abstract | Galectin (Gal)-3 is a profibrotic β-galactoside-binding lectin that plays a key role in the pathogenesis of idiopathic pulmonary fibrosis (IPF) and IPF exacerbations. TD139 is a novel and potent small-molecule inhibitor of Gal-3.A randomised, double-blind, multicentre, placebo-controlled, phase 1/2a study was conducted to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled TD139 in 36 healthy subjects and 24 patients with IPF. Six dose cohorts of six healthy subjects were evaluated (4:2 TD139:placebo ratio) with single doses of TD139 (0.15-50 mg) and three dose cohorts of eight patients with IPF (5:3 TD139:placebo ratio) with once-daily doses of TD139 (0.3-10 mg) for 14 days.Inhaled TD139 was well tolerated with no significant treatment-related side-effects. TD139 was rapidly absorbed, with mean time taken to reach maximum plasma concentration (
) values ranging from 0.6 to 3 h and a plasma half-life (
) of 8 h. The concentration of TD139 in the lung was >567-fold higher than in the blood, with systemic exposure predicting exposure in the target compartment. Gal-3 expression on alveolar macrophages was reduced in the 3 and 10 mg dose groups compared with placebo, with a concentration-dependent inhibition demonstrated. Inhibition of Gal-3 expression in the lung was associated with reductions in plasma biomarkers centrally relevant to IPF pathobiology (platelet-derived growth factor-BB, plasminogen activator inhibitor-1, Gal-3, CCL18 and YKL-40).TD139 is safe and well tolerated in healthy subjects and IPF patients. It was shown to suppress Gal-3 expression on bronchoalveolar lavage macrophages and, in a concerted fashion, decrease plasma biomarkers associated with IPF progression. |
|---|---|
| AbstractList | Galectin (Gal)-3 is a profibrotic β-galactoside-binding lectin that plays a key role in the pathogenesis of idiopathic pulmonary fibrosis (IPF) and IPF exacerbations. TD139 is a novel and potent small-molecule inhibitor of Gal-3.A randomised, double-blind, multicentre, placebo-controlled, phase 1/2a study was conducted to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled TD139 in 36 healthy subjects and 24 patients with IPF. Six dose cohorts of six healthy subjects were evaluated (4:2 TD139:placebo ratio) with single doses of TD139 (0.15-50 mg) and three dose cohorts of eight patients with IPF (5:3 TD139:placebo ratio) with once-daily doses of TD139 (0.3-10 mg) for 14 days.Inhaled TD139 was well tolerated with no significant treatment-related side-effects. TD139 was rapidly absorbed, with mean time taken to reach maximum plasma concentration (C max) values ranging from 0.6 to 3 h and a plasma half-life (T 1/2) of 8 h. The concentration of TD139 in the lung was >567-fold higher than in the blood, with systemic exposure predicting exposure in the target compartment. Gal-3 expression on alveolar macrophages was reduced in the 3 and 10 mg dose groups compared with placebo, with a concentration-dependent inhibition demonstrated. Inhibition of Gal-3 expression in the lung was associated with reductions in plasma biomarkers centrally relevant to IPF pathobiology (platelet-derived growth factor-BB, plasminogen activator inhibitor-1, Gal-3, CCL18 and YKL-40).TD139 is safe and well tolerated in healthy subjects and IPF patients. It was shown to suppress Gal-3 expression on bronchoalveolar lavage macrophages and, in a concerted fashion, decrease plasma biomarkers associated with IPF progression.Galectin (Gal)-3 is a profibrotic β-galactoside-binding lectin that plays a key role in the pathogenesis of idiopathic pulmonary fibrosis (IPF) and IPF exacerbations. TD139 is a novel and potent small-molecule inhibitor of Gal-3.A randomised, double-blind, multicentre, placebo-controlled, phase 1/2a study was conducted to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled TD139 in 36 healthy subjects and 24 patients with IPF. Six dose cohorts of six healthy subjects were evaluated (4:2 TD139:placebo ratio) with single doses of TD139 (0.15-50 mg) and three dose cohorts of eight patients with IPF (5:3 TD139:placebo ratio) with once-daily doses of TD139 (0.3-10 mg) for 14 days.Inhaled TD139 was well tolerated with no significant treatment-related side-effects. TD139 was rapidly absorbed, with mean time taken to reach maximum plasma concentration (C max) values ranging from 0.6 to 3 h and a plasma half-life (T 1/2) of 8 h. The concentration of TD139 in the lung was >567-fold higher than in the blood, with systemic exposure predicting exposure in the target compartment. Gal-3 expression on alveolar macrophages was reduced in the 3 and 10 mg dose groups compared with placebo, with a concentration-dependent inhibition demonstrated. Inhibition of Gal-3 expression in the lung was associated with reductions in plasma biomarkers centrally relevant to IPF pathobiology (platelet-derived growth factor-BB, plasminogen activator inhibitor-1, Gal-3, CCL18 and YKL-40).TD139 is safe and well tolerated in healthy subjects and IPF patients. It was shown to suppress Gal-3 expression on bronchoalveolar lavage macrophages and, in a concerted fashion, decrease plasma biomarkers associated with IPF progression. Galectin (Gal)-3 is a profibrotic β-galactoside-binding lectin that plays a key role in the pathogenesis of idiopathic pulmonary fibrosis (IPF) and IPF exacerbations. TD139 is a novel and potent small-molecule inhibitor of Gal-3.A randomised, double-blind, multicentre, placebo-controlled, phase 1/2a study was conducted to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled TD139 in 36 healthy subjects and 24 patients with IPF. Six dose cohorts of six healthy subjects were evaluated (4:2 TD139:placebo ratio) with single doses of TD139 (0.15-50 mg) and three dose cohorts of eight patients with IPF (5:3 TD139:placebo ratio) with once-daily doses of TD139 (0.3-10 mg) for 14 days.Inhaled TD139 was well tolerated with no significant treatment-related side-effects. TD139 was rapidly absorbed, with mean time taken to reach maximum plasma concentration ( ) values ranging from 0.6 to 3 h and a plasma half-life ( ) of 8 h. The concentration of TD139 in the lung was >567-fold higher than in the blood, with systemic exposure predicting exposure in the target compartment. Gal-3 expression on alveolar macrophages was reduced in the 3 and 10 mg dose groups compared with placebo, with a concentration-dependent inhibition demonstrated. Inhibition of Gal-3 expression in the lung was associated with reductions in plasma biomarkers centrally relevant to IPF pathobiology (platelet-derived growth factor-BB, plasminogen activator inhibitor-1, Gal-3, CCL18 and YKL-40).TD139 is safe and well tolerated in healthy subjects and IPF patients. It was shown to suppress Gal-3 expression on bronchoalveolar lavage macrophages and, in a concerted fashion, decrease plasma biomarkers associated with IPF progression. |
| Author | Schambye, Hans Forrest, Ian A Ford, Paul Maher, Toby M Hirani, Nikhil Molyneaux, Philip L Funston, Wendy Simpson, A John Pedersen, Anders Keeling, Lucy Mills, Ross Nicol, Lisa Zetterberg, Fredrik Li, Feng Sethi, Tariq Nilsson, Ulf J Humphries, Duncan Karmakar, Utsa MacKinnon, Alison C Paul, Lyn Gibbons, Michael A Slack, Robert J Tantawi, Susan Gravelle, Lise Leffler, Hakon |
| Author_xml | – sequence: 1 givenname: Nikhil surname: Hirani fullname: Hirani, Nikhil email: n.hirani@ed.ac.uk organization: MRC Centre for Inflammation Research, The Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK n.hirani@ed.ac.uk – sequence: 2 givenname: Alison C orcidid: 0000-0002-7967-4141 surname: MacKinnon fullname: MacKinnon, Alison C organization: Galecto, Copenhagen, Denmark – sequence: 3 givenname: Lisa surname: Nicol fullname: Nicol, Lisa organization: MRC Centre for Inflammation Research, The Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK – sequence: 4 givenname: Paul surname: Ford fullname: Ford, Paul organization: Galecto, Copenhagen, Denmark – sequence: 5 givenname: Hans surname: Schambye fullname: Schambye, Hans organization: Galecto, Copenhagen, Denmark – sequence: 6 givenname: Anders surname: Pedersen fullname: Pedersen, Anders organization: Galecto, Copenhagen, Denmark – sequence: 7 givenname: Ulf J surname: Nilsson fullname: Nilsson, Ulf J organization: Dept of Chemistry, Lund University, Lund, Sweden – sequence: 8 givenname: Hakon surname: Leffler fullname: Leffler, Hakon organization: Dept of Laboratory Medicine, Lund University, Lund, Sweden – sequence: 9 givenname: Tariq surname: Sethi fullname: Sethi, Tariq organization: Galecto, Copenhagen, Denmark – sequence: 10 givenname: Susan surname: Tantawi fullname: Tantawi, Susan organization: Galecto, Copenhagen, Denmark – sequence: 11 givenname: Lise orcidid: 0000-0003-4472-090X surname: Gravelle fullname: Gravelle, Lise organization: Galecto, Copenhagen, Denmark – sequence: 12 givenname: Robert J surname: Slack fullname: Slack, Robert J organization: Galecto, Copenhagen, Denmark – sequence: 13 givenname: Ross surname: Mills fullname: Mills, Ross organization: MRC Centre for Inflammation Research, The Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK – sequence: 14 givenname: Utsa surname: Karmakar fullname: Karmakar, Utsa organization: MRC Centre for Inflammation Research, The Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK – sequence: 15 givenname: Duncan orcidid: 0000-0002-5551-6536 surname: Humphries fullname: Humphries, Duncan organization: MRC Centre for Inflammation Research, The Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK – sequence: 16 givenname: Fredrik orcidid: 0000-0002-7789-8782 surname: Zetterberg fullname: Zetterberg, Fredrik organization: Galecto, Copenhagen, Denmark – sequence: 17 givenname: Lucy surname: Keeling fullname: Keeling, Lucy organization: Exploristics, Belfast, UK – sequence: 18 givenname: Lyn surname: Paul fullname: Paul, Lyn organization: National Institute for Health Research Respiratory Clinical Research Facility, Royal Brompton and Harefield NHS Foundation Trust, and Fibrosis Research Group, National Heart and Lung Institute, Imperial College London, London, UK – sequence: 19 givenname: Philip L orcidid: 0000-0003-1301-8800 surname: Molyneaux fullname: Molyneaux, Philip L organization: National Institute for Health Research Respiratory Clinical Research Facility, Royal Brompton and Harefield NHS Foundation Trust, and Fibrosis Research Group, National Heart and Lung Institute, Imperial College London, London, UK – sequence: 20 givenname: Feng orcidid: 0000-0002-7658-6138 surname: Li fullname: Li, Feng organization: MRC Centre for Inflammation Research, The Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK – sequence: 21 givenname: Wendy surname: Funston fullname: Funston, Wendy organization: Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK – sequence: 22 givenname: Ian A surname: Forrest fullname: Forrest, Ian A organization: Respiratory Medicine Unit, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK – sequence: 23 givenname: A John orcidid: 0000-0003-4731-7294 surname: Simpson fullname: Simpson, A John organization: Respiratory Medicine Unit, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK – sequence: 24 givenname: Michael A surname: Gibbons fullname: Gibbons, Michael A organization: Respiratory Dept, Institute of Biomedical and Clinical Science, Royal Devon and Exeter NHS Foundation Trust, Medical School, University of Exeter, Exeter, UK – sequence: 25 givenname: Toby M surname: Maher fullname: Maher, Toby M organization: Keck School of Medicine, University of Southern California, Los Angeles, CA, USA |
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| Title | Target inhibition of galectin-3 by inhaled TD139 in patients with idiopathic pulmonary fibrosis |
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