Development and evaluation of inhalable composite niclosamide-lysozyme particles: A broad-spectrum, patient-adaptable treatment for coronavirus infections and sequalae
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WHO Director-General’s opening remarks at the Mission briefing on COVID-19–12 March 2020 [Internet].; 2020
R Li, 2020, Estimated Demand for US Hospital Inpatient and Intensive Care Unit Beds for Patients With COVID-19 Based on Comparisons With Wuhan and Guangzhou, China., JAMA Netw Open., 3, e208297, 10.1001/jamanetworkopen.2020.8297
IF Miller, 2020, Disease and healthcare burden of COVID-19 in the United States, Nat Med, 26, 1212, 10.1038/s41591-020-0952-y
SM Kissler, 2020, Projecting the transmission dynamics of SARS-CoV-2 through the postpandemic period, Science, 368, 860, 10.1126/science.abb5793
S Jeon, 2020, Identification of Antiviral Drug Candidates against SARS-CoV-2 from FDA-Approved Drugs, Antimicrobial Agents and Chemotherapy, 64, e00819, 10.1128/AAC.00819-20
NC Gassen, 2019, SKP2 attenuates autophagy through Beclin1-ubiquitination and its inhibition reduces MERS-Coronavirus infection., Nat Commun., 10, 5770, 10.1038/s41467-019-13659-4
A Jurgeit, 2012, Niclosamide is a proton carrier and targets acidic endosomes with broad antiviral effects., PLoS Pathog., 8, e1002976, 10.1371/journal.ppat.1002976
J Xu, 2020, Broad Spectrum Antiviral Agent Niclosamide and Its Therapeutic Potential., ACS Infect Dis.
Y Li, 2014, Multi-targeted therapy of cancer by niclosamide: A new application for an old drug, Cancer Lett, 349, 8, 10.1016/j.canlet.2014.04.003
W Chen, 2018, Niclosamide: Beyond an antihelminthic drug, Cell Signal, 41, 89, 10.1016/j.cellsig.2017.04.001
J Tam, 2018, Host-targeted niclosamide inhibits C. difficile virulence and prevents disease in mice without disrupting the gut microbiota, Nat Commun, 9, 5233, 10.1038/s41467-018-07705-w
BD Fonseca, 2012, Structure-activity analysis of niclosamide reveals potential role for cytoplasmic pH in control of mammalian target of rapamycin complex 1 (mTORC1) signaling., J Biol Chem, 287, 17530, 10.1074/jbc.M112.359638
ML Circu, 2016, A Novel High Content Imaging-Based Screen Identifies the Anti-Helminthic Niclosamide as an Inhibitor of Lysosome Anterograde Trafficking and Prostate Cancer Cell Invasion., PLoS One, 11, e0146931, 10.1371/journal.pone.0146931
JE Ippolito, 2016, Extracellular pH Modulates Neuroendocrine Prostate Cancer Cell Metabolism and Susceptibility to the Mitochondrial Inhibitor Niclosamide., PLoS One, 11, e0159675, 10.1371/journal.pone.0159675
RA Mook, 2015, Structure-activity studies of Wnt/beta-catenin inhibition in the Niclosamide chemotype: Identification of derivatives with improved drug exposure, Bioorg Med Chem, 23, 5829, 10.1016/j.bmc.2015.07.001
N Tharmalingam, 2018, Repurposing the anthelmintic drug niclosamide to combat Helicobacter pylori, Sci Rep, 8, 3701, 10.1038/s41598-018-22037-x
R Rajamuthiah, 2015, Repurposing salicylanilide anthelmintic drugs to combat drug resistant Staphylococcus aureus., PloS one., 10, 10.1371/journal.pone.0124595
T Gwisai, 2017, Repurposing niclosamide as a versatile antimicrobial surface coating against device-associated, hospital-acquired bacterial infections., Biomedical Materials, 12, 045010, 10.1088/1748-605X/aa7105
NS Torres, 2016, Screening a commercial library of pharmacologically active small molecules against Staphylococcus aureus biofilms, Antimicrobial agents and chemotherapy, 60, 5663, 10.1128/AAC.00377-16
R Domalaon, 2019, The Anthelmintic Drug Niclosamide Synergizes with Colistin and Reverses Colistin Resistance in Gram-Negative Bacilli, Antimicrobial Agents and Chemotherapy, 63, e02574, 10.1128/AAC.02574-18
G Costabile, 2015, Toward repositioning niclosamide for antivirulence therapy of Pseudomonas aeruginosa lung infections: development of inhalable formulations through nanosuspension technology, Molecular pharmaceutics, 12, 2604, 10.1021/acs.molpharmaceut.5b00098
F Imperi, 2013, New life for an old drug: the anthelmintic drug niclosamide inhibits Pseudomonas aeruginosa quorum sensing, Antimicrobial agents and chemotherapy, 57, 996, 10.1128/AAC.01952-12
R Ayerbe-Algaba, 2018, Synergistic Activity of Niclosamide in Combination With Colistin Against Colistin-Susceptible and Colistin-Resistant Acinetobacter baumannii and Klebsiella pneumoniae, Frontiers in Cellular and Infection Microbiology, 8
Z Sun, 1999, Antituberculosis activity of certain antifungal and antihelmintic drugs, Tubercle and Lung disease, 79, 319, 10.1054/tuld.1999.0212
G Piccaro, 2013, Activities of Drug Combinations against <span class = "named-content genus-species" id = "named-content-1">Mycobacterium tuberculosis Grown in Aerobic and Hypoxic Acidic Conditions., Antimicrobial agents and chemotherapy, 57, 1428, 10.1128/AAC.02154-12
MV Zhurina, 2017, Niclosamide as a promising antibiofilm agent, Microbiology, 86, 455, 10.1134/S0026261717040154
I Cabrita, 2019, Niclosamide repurposed for the treatment of inflammatory airway disease., JCI Insight., 4, 10.1172/jci.insight.128414
PubChem Database. Niclosamide, CID = 4477, [Internet]. [cited Apr. 28, 2020]. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/Niclosamide.
S Jeon, 2020, Identification of antiviral drug candidates against SARS-CoV-2 from FDA-approved drugs., bioRxiv, 2020
MT Schweizer, 2018, A phase I study of niclosamide in combination with enzalutamide in men with castration-resistant prostate cancer, PloS one, 13, e0198389, 10.1371/journal.pone.0198389
G Costabile, 2015, Toward Repositioning Niclosamide for Antivirulence Therapy of Pseudomonas aeruginosa Lung Infections: Development of Inhalable Formulations through Nanosuspension Technology, Mol Pharm, 12, 2604, 10.1021/acs.molpharmaceut.5b00098
Inactive Ingredients Database [Internet]. 2019. Available from: https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm.
PM Kanth, 2018, Nebulized Mannitol, Particle Distribution, and Cough in Idiopathic Pulmonary Fibrosis., Respir Care, 63, 1407, 10.4187/respcare.06153
HO KOSKELA, 2005, Dissociation in the effect of nedocromil on mannitol-induced cough or bronchoconstriction in asthmatic subjects*., Respirology, 10, 442, 10.1111/j.1440-1843.2005.00724.x
S Sahakijpijarn, 2020, Post-inhalation cough with therapeutic aerosols: Formulation considerations, Adv Drug Deliv Rev
CC Lai, 2020, Asymptomatic carrier state, acute respiratory disease, and pneumonia due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): Facts and myths., J Microbiol Immunol Infect, 53, 404, 10.1016/j.jmii.2020.02.012
W Lee, 2015, Anti-Inflammatory Effects of Lysozyme Against HMGB1 in Human Endothelial Cells and in Mice, Inflammation, 38, 1911, 10.1007/s10753-015-0171-8
J Malaczewska, 2019, Antiviral effects of nisin, lysozyme, lactoferrin and their mixtures against bovine viral diarrhoea virus, BMC Vet Res, 15, 318, 10.1186/s12917-019-2067-6
X Zhang, 2008, Study on Antimicrobial and Antiviral Activities of Lysozyme From Marine Strain S-12-86 In Vitro., Agricultural Sciences in China, 7, 112, 10.1016/S1671-2927(08)60029-2
S Lee-Huang, 2005, Structural and Functional Modeling of Human Lysozyme Reveals a Unique Nonapeptide, HL9, with Anti-HIV Activity, Biochemistry, 44, 4648, 10.1021/bi0477081
HR Ibrahim, 2011, Human Lysozyme Possesses Novel Antimicrobial Peptides within Its N-terminal Domain that Target Bacterial Respiration, Journal of Agricultural and Food Chemistry, 59, 10336, 10.1021/jf2020396
SM Travis, 1999, Activity of abundant antimicrobials of the human airway, American journal of respiratory cell and molecular biology, 20, 872, 10.1165/ajrcmb.20.5.3572
SA Ragland, 2017, From bacterial killing to immune modulation: Recent insights into the functions of lysozyme., PLoS Pathog., 13, e1006512, 10.1371/journal.ppat.1006512
AD Brunaugh, 2019, Effect of Particle Formation Process on Characteristics and Aerosol Performance of Respirable Protein Powders, Molecular Pharmaceutics
S Ferrati, 2018, Influence of Formulation Factors on the Aerosol Performance and Stability of Lysozyme Powders: a Systematic Approach., AAPS PharmSciTech., 19, 2755, 10.1208/s12249-018-0980-9
WC Hinds, 1999, Aerosol technology: properties, behavior, and measurement of airborne particles
Lenth RV, Lenth MRV, Vdgraph S. Package ‘rsm’. 2018.
R Development Core Team, 2019, R: A language and environment for statistical computing
D Arora, 2010, In vitro aqueous fluid-capacity-limited dissolution testing of respirable aerosol drug particles generated from inhaler products, Pharm Res, 27, 786, 10.1007/s11095-010-0070-5
M Rohrschneider, 2015, Evaluation of the Transwell System for Characterization of Dissolution Behavior of Inhalation Drugs: Effects of Membrane and Surfactant, Mol Pharm, 12, 2618, 10.1021/acs.molpharmaceut.5b00221
M Hassoun, 2018, Design and development of a biorelevant simulated human lung fluid, J Drug Deliv Sci Technol, 47, 485, 10.1016/j.jddst.2018.08.006
DJ Phillips, 2012, Overcoming sink limitations in dissolution testing: a review of traditional methods and the potential utility of biphasic systems, Journal of Pharmacy and Pharmacology, 64, 1549, 10.1111/j.2042-7158.2012.01523.x
VA Marple, 2003, Next generation pharmaceutical impactor (a new impactor for pharmaceutical inhaler testing). Part II: Archival calibration., Journal of Aerosol medicine, 16, 301, 10.1089/089426803769017668
ZN Warnken, 2018, Personalized medicine in nasal delivery: the use of patient-specific administration parameters to improve nasal drug targeting using 3D printed nasal replica casts, Molecular Pharmaceutics
DV Doughty, 2011, Automated actuation of nasal spray products: determination and comparison of adult and pediatric settings, Drug Development and Industrial Pharmacy, 37, 359, 10.3109/03639045.2010.520321
J Schindelin, 2012, Fiji: an open-source platform for biological-image analysis, Nature methods, 9, 676, 10.1038/nmeth.2019
W Chanput, 2010, Transcription profiles of LPS-stimulated THP-1 monocytes and macrophages: a tool to study inflammation modulating effects of food-derived compounds, Food Funct, 1, 254, 10.1039/c0fo00113a
M Elshikh, 2016, Resazurin-based 96-well plate microdilution method for the determination of minimum inhibitory concentration of biosurfactants, Biotechnol Lett, 38, 1015, 10.1007/s10529-016-2079-2
YJ Hou, 2020, SARS-CoV-2 Reverse Genetics Reveals a Variable Infection Gradient in the Respiratory Tract, Cell, 182, 429, 10.1016/j.cell.2020.05.042
W Wang, 2012, Immunogenicity of protein aggregates—concerns and realities, Int J Pharm, 431, 1, 10.1016/j.ijpharm.2012.04.040
KD Ratanji, 2014, Immunogenicity of therapeutic proteins: influence of aggregation, J Immunotoxicol, 11, 99, 10.3109/1547691X.2013.821564
EM Moussa, 2016, Immunogenicity of Therapeutic Protein Aggregates, J Pharm Sci, 105, 417, 10.1016/j.xphs.2015.11.002
AA Elkordy, 2002, Integrity of crystalline lysozyme exceeds that of a spray-dried form, International journal of pharmaceutics, 247, 79, 10.1016/S0378-5173(02)00379-4
HG Boman, 2003, Antibacterial peptides: basic facts and emerging concepts, Journal of Internal Medicine, 254, 197, 10.1046/j.1365-2796.2003.01228.x
MH Orzalli, 2018, An Antiviral Branch of the IL-1 Signaling Pathway Restricts Immune-Evasive Virus Replication, Mol Cell, 71, 825, 10.1016/j.molcel.2018.07.009
CC Clay, 2014, Severe acute respiratory syndrome-coronavirus infection in aged nonhuman primates is associated with modulated pulmonary and systemic immune responses., Immunity & Ageing., 11, 4, 10.1186/1742-4933-11-4
HW Stout-Delgado, 2012, Impaired NLRP3 inflammasome function in elderly mice during influenza infection is rescued by treatment with nigericin, J Immunol, 188, 2815, 10.4049/jimmunol.1103051
SN Jackson, 2019, An In Vitro Study of Aromatic Stacking of Drug Molecules, J Am Soc Mass Spectrom, 30, 1199, 10.1007/s13361-019-02166-x
P Sanphui, 2012, Pharmaceutical Cocrystals of Niclosamide., Crystal Growth & Design., 12, 4588, 10.1021/cg300784v
FG Wu, 2015, Complexation of Lysozyme with Sodium Poly(styrenesulfonate) via the Two-State and Non-Two-State Unfoldings of Lysozyme., J Phys Chem B, 119, 14382, 10.1021/acs.jpcb.5b07277
S Pawar, 2020, Investigation of complexation of amlodipine with lysozyme and its effect on lysozyme crystal growth, Spectrochim Acta A Mol Biomol Spectrosc, 227, 117623, 10.1016/j.saa.2019.117623
COVID-19 Update: FDA Broadens Emergency Use Authorization for Veklury (remdesivir) to Include All Hospitalized Patients for Treatment of COVID-19 [Internet]. 2020. Available from: https://www.fda.gov/news-events/press-announcements/covid-19-update-fda-broadens-emergency-use-authorization-veklury-remdesivir-include-all-hospitalized
JH Beigel, 2020, Remdesivir for the Treatment of Covid-19—Preliminary Report, N Engl J Med
Safety, Tolerability and Pharmacokinetics of Inhaled Nanoparticle Formulation of Remdesivir (GS-5734) and NA-831. https://ClinicalTrials.gov/show/NCT04480333.
Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment. https://ClinicalTrials.gov/show/NCT04292730.
S Sahakijpijarn, 2020, Development of Remdesivir as a Dry Powder for Inhalation by Thin Film Freezing., Pharmaceutics, 12, 10.3390/pharmaceutics12111002
TP Sheahan, 2020, Comparative therapeutic efficacy of remdesivir and combination lopinavir, ritonavir, and interferon beta against MERS-CoV., Nat Commun., 11, 222, 10.1038/s41467-019-13940-6
DM Del Valle, 2020, An inflammatory cytokine signature predicts COVID-19 severity and survival, Nat Med
F Zhou, 2020, Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study, The Lancet, 395, 1054, 10.1016/S0140-6736(20)30566-3
P Andrews, 1982, The biology and toxicology of molluscicides, bayluscide., Pharmacology & Therapeutics., 19, 245, 10.1016/0163-7258(82)90064-X
J Weers, 2017, The Impact of Inspiratory Flow Rate on Drug Delivery to the Lungs with Dry Powder Inhalers, Pharm Res, 34, 507, 10.1007/s11095-016-2050-x
C Qin, 2020, Dysregulation of immune response in patients with COVID-19 in Wuhan, China, Clin Infect Dis
E Frohlich, 2016, Measurements of Deposition, Lung Surface Area and Lung Fluid for Simulation of Inhaled Compounds., Front Pharmacol, 7, 181, 10.3389/fphar.2016.00181
C Dufes, 2003, Brain delivery of vasoactive intestinal peptide (VIP) following nasal administration to rats., International journal of pharmaceutics, 255, 87, 10.1016/S0378-5173(03)00039-5
H Neffen, 2010, Ciclesonide, a hypotonic intranasal corticosteroid, Allergy & Asthma Proceedings
L Mao, 2020, Neurological manifestations of hospitalized patients with COVID-19 in Wuhan, China: a retrospective case series study.
Y Wu, 2020, Nervous system involvement after infection with COVID-19 and other coronaviruses, Brain Behav Immun., 87, 18, 10.1016/j.bbi.2020.03.031