Inhaled nintedanib is well-tolerated and delivers key pharmacokinetic parameters required to treat bleomycin-induced pulmonary fibrosis

Pulmonary Pharmacology and Therapeutics - Tập 63 - Trang 101938 - 2020
Mark W. Surber1, Steve Beck1, Stephen Pham1, Angela T. Marsden2, Senthil K. Gandi2, James Baily3, Mary C. McElroy2
1Avalyn Pharma, Inc., 701 Pike Street, Suite 1500, Seattle, WA, 98101, USA
2Respiratory Pharmacology, Charles River Laboratories, Edinburgh, EH33 2NE, UK
3Pathology Department, Charles River Laboratories, Edinburgh, EH33 2NE, UK

Tài liệu tham khảo

Raghu, 2011, ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management, Am. J. Respir. Crit. Care Med., 183, 788, 10.1164/rccm.2009-040GL Hutchinson, 2015, Global incidence and mortality of idiopathic pulmonary fibrosis: a systematic review, Eur. Respir. J., 46, 795, 10.1183/09031936.00185114 Sakai, 2013, Fibrosis of two: epithelial cell-fibroblast interactions in pulmonary fibrosis, Biochim. Biophys. Acta, 1832, 911, 10.1016/j.bbadis.2013.03.001 Wind, 2019, Clinical pharmacokinetics and pharmacodynamics of nintedanib, Clin. Pharmacokinet., 58, 1131, 10.1007/s40262-019-00766-0 Selman, 2001, Ann. Intern. Med., 134, 136, 10.7326/0003-4819-134-2-200101160-00015 Chaudhary, 2007, Inhibition of PDGF, VEGF and FGF signalling attenuates fibrosis, Eur. Respir. J., 29, 976, 10.1183/09031936.00152106 Wollin, 2015, Mode of action of nintedanib in the treatment of idiopathic pulmonary fibrosis, Eur. Respir. J., 45, 1434, 10.1183/09031936.00174914 Richeldi, 2011, Efficacy of a tyrosine kinase inhibitor in idiopathic pulmonary fibrosis, N. Engl. J. Med., 365, 1079, 10.1056/NEJMoa1103690 Richeldi, 2014, Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis, N. Engl. J. Med., 370, 2071, 10.1056/NEJMoa1402584 Distler, 2019, Nintedanib for systemic sclerosis–associated interstitial lung disease, N. Engl. J. Med., 380, 2518, 10.1056/NEJMoa1903076 Flaherty, 2019, Nintedanib in progressive fibrosing interstitial lung diseases, N. Engl. J. Med., 381, 1718, 10.1056/NEJMoa1908681 Liu, 2017, The bleomycin model of pulmonary fibrosis, Methods Mol. Biol., 1627, 27, 10.1007/978-1-4939-7113-8_2 Jenkins, 2017, An official American thoracic society workshop report: use of animal models for the preclinical assessment of potential therapies for pulmonary fibrosis. ATS assembly on respiratory cell and molecular biology, Am. J. Respir. Cell Mol. Biol., 56, 667, 10.1165/rcmb.2017-0096ST Adamson, 1979, Bleomycin-induced injury and metaplasia of alveolar type 2 cells. Relationship of cellular responses to drug presence in the lung, Am. J. Pathol., 96, 531 Liu, 2019, Telomerase reverse transcriptase ameliorates lung fibrosis by protecting alveolar epithelial cells against senescence, J. Biol. Chem., 294, 8861, 10.1074/jbc.RA118.006615 Bauer, 2015, A novel genomic signature with translational significance for human idiopathic pulmonary fibrosis, Am. J. Respir. Cell Mol. Biol., 52, 217, 10.1165/rcmb.2013-0310OC Ammar, 2019, A robust data-driven genomic signature for idiopathic pulmonary fibrosis with applications for translational model selection, PLoS One, 14, 10.1371/journal.pone.0215565 McElroy, 2019, Understanding of pharmacokinetics and exposure drives use of nintedanib as a positive control reference item in a rat model of bleomycin-induced fibrosis, Eur. Respir. J., 54 McElroy, 2019, Respiratory assessment using intra-plural pressure/head-out plethysmography in a repetitive bleomycin challenge model of pulmonary fibrosis in conscious rats, Am. J. Respir. Crit. Care Med., 199, A5423 Egger, 2013, Administration of bleomycin via the oropharyngeal aspiration route leads to sustained lung fibrosis in mice and rats as quantified by UTE-MRI and histology, PLoS One, 8, 10.1371/journal.pone.0063432 Schafer, 2018, Use of severity grades to characterise histopathologic changes, Toxicol. Pathol., 46, 256, 10.1177/0192623318761348 Liscio, 2016, Development of a reference measurement procedure and certified reference material for the determination of hydroxyproline in meat, Food Anal. Methods, 9, 1461, 10.1007/s12161-015-0329-x Schmid, 2018, Population pharmacokinetics of nintedanib, an inhibitor of tyrosine kinases, in patients with non-small cell lung cancer or idiopathic pulmonary fibrosis, Canc. Chemother. Pharmacol., 81, 89, 10.1007/s00280-017-3452-0 Roth, 2015, Nintedanib: from discovery to the clinic, J. Med. Chem., 58, 1053, 10.1021/jm501562a Kelley, 1989, Localisation of collagen in the rat lung: biochemical quantitation of types 1 and 111 collagen in small airways, vessles and parenchyma, Lung, 167, 313, 10.1007/BF02714960 Surber, 2014, Inhaled pirfenidone improves animal efficacy through superior pulmonary and vascular pharmacokinetics, Am. Thoracic Soc., A6599 Hübner, 2008, Standardized quantification of pulmonary fibrosis in histological samples Biotechniques, 44, 507 Epstein-Shochet, 2020, Inhalation: A means to explore and optimize nintedanib’s pharmacokinetic/pharmacodynamic relationship, [published online ahead of print, 2020 Aug 1]. Pulm Pharmacol Ther