Synergistic Antiviral Activity of Pamapimod and Pioglitazone against SARS-CoV-2 and Its Variants of Concern

International Journal of Molecular Sciences - Tập 23 Số 12 - Trang 6830
Christian Setz1, Maximilian Große1, Janina Auth1, Maria Fröba1, Pia Rauch1, Andreas R. Bausch2, Matthew B. Wright2, Ulrich S. Schubert1
1Institute of Virology, Friedrich-Alexander University Erlangen-Nürnberg (FAU), 91054 Erlangen, Germany
2Kinarus Therapeutics AG, 4057 Basel, Switzerland

Tóm tắt

The SARS-CoV-2 pandemic remains a major public health threat, especially due to newly emerging SARS-CoV-2 Variants of Concern (VoCs), which are more efficiently transmitted, more virulent, and more able to escape naturally acquired and vaccine-induced immunity. Recently, the protease inhibitor Paxlovid® and the polymerase inhibitor molnupiravir, both targeting mutant-prone viral components, were approved for high-risk COVID-19 patients. Nevertheless, effective therapeutics to treat COVID-19 are urgently needed, especially small molecules acting independently of VoCs and targeting genetically stable cellular pathways which are crucial for viral replication. Pamapimod is a selective inhibitor of p38 Mitogen-Activated Protein Kinase alpha (p38 MAPKα) that has been extensively clinically evaluated for the treatment of rheumatoid arthritis. Signaling via p38 has recently been described as a key pathway for the replication of SARS-CoV-2. Here, we reveal that the combination of pamapimod with pioglitazone, an anti-inflammatory and approved drug for the treatment of type 2 diabetes, possesses potent and synergistic activity to inhibit SARS-CoV-2 replication in vitro. Both drugs showed similar antiviral potency across several cultured cell types and similar antiviral activity against SARS-CoV-2 Wuhan type, and the VoCs Alpha, Beta, Gamma, Delta, and Omicron. These data support the combination of pamapimod and pioglitazone as a potential therapy to reduce duration and severity of disease in COVID-19 patients, an assumption currently evaluated in an ongoing phase II clinical study.

Từ khóa


Tài liệu tham khảo

Johns Hopkins University & Medicine (2022, June 06). COVID-19 Dashboard by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University. Available online: https://coronavirus.jhu.edu/map.html.

Collier, 2021, Sensitivity of SARS-CoV-2 B.1.1.7 to mRNA vaccine-elicited antibodies, Nature, 593, 136, 10.1038/s41586-021-03412-7

Wibmer, 2021, SARS-CoV-2 501Y.V2 escapes neutralization by South African COVID-19 donor plasma, Nat. Med., 27, 622, 10.1038/s41591-021-01285-x

Korber, 2020, Tracking Changes in SARS-CoV-2 Spike: Evidence that D614G Increases Infectivity of the COVID-19 Virus, Cell, 182, 812, 10.1016/j.cell.2020.06.043

Galloway, 2021, Emergence of SARS-CoV-2 B.1.1.7 Lineage—United States, December 29, 2020–January 12, 2021, MMWR Morb. Mortal. Wkly. Rep., 70, 95, 10.15585/mmwr.mm7003e2

Kemp, S.A., Meng, B., Ferriera, I.A., Datir, R., Harvey, W.T., Papa, G., Lytras, S., Collier, D.A., Mohamed, A., and Gallo, G. (2021). Recurrent emergence and transmission of a SARS-CoV-2 spike deletion H69/V70. bioRxiv.

Tegally, H., Wilkinson, E., Giovanetti, M., Iranzadeh, A., Fonseca, V., Giandhari, J., Doolabh, D., Pillay, S., San, E.J., and Msomi, N. (2020). Emergence and rapid spread of a new severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) lineage with multiple spike mutations in South Africa. medRxiv.

Public Health England (2022, April 13). Investigation of SARS-CoV-2 Variants of Concern: Technical Briefings, Available online: https://www.gov.uk/government/publications/investigation-of-novel-sars-cov-2-variant-variant-of-concern-20201201.

Mwenda, 2021, Detection of B.1.351 SARS-CoV-2 Variant Strain—Zambia, December 2020, MMWR Morb. Mortal. Wkly. Rep., 70, 280, 10.15585/mmwr.mm7008e2

National Institute of Infectious Diseases (NIID) of Japan (2021, July 29). Brief Report: New Variant Strain of SARS-CoV-2 Identified in Travelers from Brazil, Available online: https://www.niid.go.jp/niid/en/2019-ncov-e/10108-covid19-33-en.html.

Cherian, S., Potdar, V., Jadhav, S., Yadav, P., Gupta, N., Das, M., Rakshit, P., Singh, S., Abraham, P., and Panda, S. (2021). Convergent evolution of SARS-CoV-2 spike mutations, L452R, E484Q and P681R, in the second wave of COVID-19 in Maharashtra, India. bioRxiv.

Volz, 2021, Assessing transmissibility of SARS-CoV-2 lineage B.1.1.7 in England, Nature, 593, 266, 10.1038/s41586-021-03470-x

Davies, 2021, Estimated transmissibility and impact of SARS-CoV-2 lineage B.1.1.7 in England, Science, 372, eabg3055, 10.1126/science.abg3055

Kim, Y.J., Jang, U.S., Soh, S.M., Lee, J.Y., and Lee, H.R. (2021). The Impact on Infectivity and Neutralization Efficiency of SARS-CoV-2 Lineage B.1.351 Pseudovirus. Viruses, 13.

Planas, 2021, Reduced sensitivity of SARS-CoV-2 variant Delta to antibody neutralization, Nature, 596, 276, 10.1038/s41586-021-03777-9

Wang, P., Casner, R.G., Nair, M.S., Wang, M., Yu, J., Cerutti, G., Liu, L., Kwong, P.D., Huang, Y., and Shapiro, L. (2021). Increased Resistance of SARS-CoV-2 Variant P.1 to Antibody Neutralization. bioRxiv.

World Health Organization (2021, November 28). Classification of Omicron (B. 1.1. 529): SARS-CoV-2 Variant of Concern. Available online: https://www.who.int/news/item/26-11-2021-classification-of-omicron-(B.1.1.529)-Sars-Cov-2-Variant-of-Concern.

Karim, 2021, Omicron SARS-CoV-2 variant: A new chapter in the COVID-19 pandemic, Lancet, 398, 2126, 10.1016/S0140-6736(21)02758-6

Wu, C.-R., Yin, W.-C., Jiang, Y., and Xu, H.E. (2022). Structure genomics of SARS-CoV-2 and its Omicron variant: Drug design templates for COVID-19. Acta Pharmacol. Sin., 1–13.

Cao, 2022, Omicron escapes the majority of existing SARS-CoV-2 neutralizing antibodies, Nature, 602, 657, 10.1038/s41586-021-04385-3

WHO (2022, February 08). Therapeutics and COVID-19: Living Guideline. Available online: https://www.who.int/publications/i/item/WHO-2019-nCoV-therapeutics-2022.1.

EMA (2022, February 08). EMA Issues Advice on Use of Paxlovid (PF-07321332 and Ritonavir) for the Treatment of COVID-19: Rolling Review Starts in Parallel. Available online: https://www.ema.europa.eu/en/news/ema-issues-advice-use-paxlovid-pf-07321332-ritonavir-treatment-covid-19-rolling-review-starts.

National Insitutes of Health (2021, July 28). COVID-19 Treatment Guidelines—Therapeutic Management of Nonhospitalized Adults With COVID-19, Available online: https://www.covid19treatmentguidelines.nih.gov/management/clinical-management/nonhospitalized-adults--therapeutic-management.

Singh, 2021, Molnupiravir in COVID-19: A systematic review of literature, Diabetes Metab. Syndr., 15, 102329, 10.1016/j.dsx.2021.102329

Zakaria, 2018, Cellular Targets for the Treatment of Flavivirus Infections, Front. Cell. Infect. Microbiol., 8, 398, 10.3389/fcimb.2018.00398

Gheblawi, 2020, Angiotensin-Converting Enzyme 2: SARS-CoV-2 Receptor and Regulator of the Renin-Angiotensin System: Celebrating the 20th Anniversary of the Discovery of ACE2, Circ. Res., 126, 1456, 10.1161/CIRCRESAHA.120.317015

Park, 2007, p38 mitogen-activated protein kinase inhibition ameliorates angiotensin II-induced target organ damage, Hypertension, 49, 481, 10.1161/01.HYP.0000256831.33459.ea

Crowley, 2017, Immunologic Effects of the Renin-Angiotensin System, J. Am. Soc. Nephrol., 28, 1350, 10.1681/ASN.2016101066

Silveira, 2013, ACE2, angiotensin-(1-7) and Mas receptor axis in inflammation and fibrosis, Br. J. Pharmacol., 169, 477, 10.1111/bph.12159

Yu, 2018, Angiotensin-converting enzyme 2-angiotensin (1-7)-Mas axis prevents pancreatic acinar cell inflammatory response via inhibition of the p38 mitogen-activated protein kinase/nuclear factor-κB pathway, Int. J. Mol. Med., 41, 409

Scott, 2011, Reactive oxygen species and p38 mitogen-activated protein kinase mediate tumor necrosis factor α-converting enzyme (TACE/ADAM-17) activation in primary human monocytes, J. Biol. Chem., 286, 35466, 10.1074/jbc.M111.277434

Hill, 2008, Pamapimod, a novel p38 mitogen-activated protein kinase inhibitor: Preclinical analysis of efficacy and selectivity, J. Pharmacol. Exp. Ther., 327, 610, 10.1124/jpet.108.139006

Alten, 2010, Efficacy and safety of pamapimod in patients with active rheumatoid arthritis receiving stable methotrexate therapy, Ann. Rheum. Dis., 69, 364, 10.1136/ard.2008.104802

Burns, 2007, Modulation of PPAR activity via phosphorylation, Biochim. Biophys. Acta, 1771, 952, 10.1016/j.bbalip.2007.04.018

Lebovitz, 2019, Thiazolidinediones: The Forgotten Diabetes Medications, Curr. Diabetes Rep., 19, 151, 10.1007/s11892-019-1270-y

Xie, 2017, Role of adipocyte mitochondria in inflammation, lipemia and insulin sensitivity in humans: Effects of pioglitazone treatment, Int. J. Obes., 10, 1038

Zhang, 2008, Pioglitazone inhibits the expression of inflammatory cytokines from both monocytes and lymphocytes in patients with impaired glucose tolerance, Arterioscler. Thromb. Vasc. Biol., 28, 2312, 10.1161/ATVBAHA.108.175687

Qiu, 2015, Pioglitazone inhibits the secretion of proinflammatory cytokines and chemokines in astrocytes stimulated with lipopolysaccharide, Int. J. Clin. Pharmacol. Ther., 53, 746, 10.5414/CP202339

Bertram, 2010, TMPRSS2 and TMPRSS4 facilitate trypsin-independent spread of influenza virus in Caco-2 cells, J. Virol., 84, 10016, 10.1128/JVI.00239-10

Aguiar, 2020, Gene expression and in situ protein profiling of candidate SARS-CoV-2 receptors in human airway epithelial cells and lung tissue, Eur. Respir. J., 56, 2001123, 10.1183/13993003.01123-2020

Pruijssers, 2020, Remdesivir Inhibits SARS-CoV-2 in Human Lung Cells and Chimeric SARS-CoV Expressing the SARS-CoV-2 RNA Polymerase in Mice, Cell Rep., 32, 107940, 10.1016/j.celrep.2020.107940

Ianevski, 2017, SynergyFinder: A web application for analyzing drug combination dose-response matrix data, Bioinformatics, 33, 2413, 10.1093/bioinformatics/btx162

Liu, 2018, Evaluation of drug combination effect using a Bliss independence dose-response surface model, Stat. Biopharm. Res., 10, 112, 10.1080/19466315.2018.1437071

Drake, 1998, Rates of spontaneous mutation, Genetics, 148, 1667, 10.1093/genetics/148.4.1667

Canovas, 2021, Diversity and versatility of p38 kinase signalling in health and disease, Nat. Rev. Mol. Cell Biol., 22, 346, 10.1038/s41580-020-00322-w

Raingeaud, 1995, Pro-inflammatory cytokines and environmental stress cause p38 mitogen-activated protein kinase activation by dual phosphorylation on tyrosine and threonine, J. Biol. Chem., 270, 7420, 10.1074/jbc.270.13.7420

Han, 1994, A MAP kinase targeted by endotoxin and hyperosmolarity in mammalian cells, Science, 265, 808, 10.1126/science.7914033

Coulthard, 2009, p38(MAPK): Stress responses from molecular mechanisms to therapeutics, Trends Mol. Med., 15, 369, 10.1016/j.molmed.2009.06.005

Cheng, 2020, Virus-induced p38 MAPK activation facilitates viral infection, Theranostics, 10, 12223, 10.7150/thno.50992

Bouhaddou, 2020, The Global Phosphorylation Landscape of SARS-CoV-2 Infection, Cell, 182, 685, 10.1016/j.cell.2020.06.034

Jimenez-Guardeño, J.M., Nieto-Torres, J.L., DeDiego, M.L., Regla-Nava, J.A., Fernandez-Delgado, R., Castaño-Rodriguez, C., and Enjuanes, L. (2014). The PDZ-binding motif of severe acute respiratory syndrome coronavirus envelope protein is a determinant of viral pathogenesis. PLoS Pathog., 10.

Gross, 2017, PPARs in obesity-induced T2DM, dyslipidaemia and NAFLD, Nat. Rev. Endocrinol., 13, 36, 10.1038/nrendo.2016.135

Devchand, 2018, The Pioglitazone Trek via Human PPAR Gamma: From Discovery to a Medicine at the FDA and Beyond, Front. Pharmacol., 9, 1093, 10.3389/fphar.2018.01093

Hussain, 2020, COVID-19 and diabetes: Knowledge in progress, Diabetes Res. Clin. Pract., 162, 108142, 10.1016/j.diabres.2020.108142

Mantovani, 2020, Diabetes as a risk factor for greater COVID-19 severity and in-hospital death: A meta-analysis of observational studies, Nutr. Metab. Cardiovasc. Dis., 30, 1236, 10.1016/j.numecd.2020.05.014

Kumar, 2020, Is diabetes mellitus associated with mortality and severity of COVID-19? A meta-analysis, Diabetes Metab. Syndr., 14, 535, 10.1016/j.dsx.2020.04.044

Nyland, 2021, Diabetes, Drug Treatment, and Mortality in COVID-19: A Multinational Retrospective Cohort Study, Diabetes, 70, 2903, 10.2337/db21-0385

Broekema, 2021, PPARgamma in Metabolism, Immunity, and Cancer: Unified and Diverse Mechanisms of Action, Front. Endocrinol., 12, 624112, 10.3389/fendo.2021.624112

Dias, S.S.G., Soares, V.C., Ferreira, A.C., Sacramento, C.Q., Fintelman-Rodrigues, N., Temerozo, J.R., Teixeira, L., Nunes da Silva, M.A., Barreto, E., and Mattos, M. (2020). Lipid droplets fuel SARS-CoV-2 replication and production of inflammatory mediators. PLoS Pathog., 16.

Fonnesu, R., Thunuguntla, V., Veeramachaneni, G.K., Bondili, J.S., La Rocca, V., Filipponi, C., Spezia, P.G., Sidoti, M., Plicanti, E., and Quaranta, P. (2022). Palmitoylethanolamide (PEA) Inhibits SARS-CoV-2 Entry by Interacting with S Protein and ACE-2 Receptor. Viruses, 14.

Große, M., Ruetalo, N., Layer, M., Hu, D., Businger, R., Rheber, S., Setz, C., Rauch, P., Auth, J., and Fröba, M. (2021). Quinine Inhibits Infection of Human Cell Lines with SARS-CoV-2. Viruses, 13.

Auth, J., Fröba, M., Große, M., Rauch, P., Ruetalo, N., Schindler, M., Morokutti-Kurz, M., Graf, P., Dolischka, A., and Prieschl-Grassauer, E. (2021). Lectin from Triticum vulgaris (WGA) Inhibits Infection with SARS-CoV-2 and Its Variants of Concern Alpha and Beta. Int. J. Mol. Sci., 22.

Becker, 2021, Immune response to SARS-CoV-2 variants of concern in vaccinated individuals, Nat. Commun., 12, 3109, 10.1038/s41467-021-23473-6

Fröba, M., Große, M., Setz, C., Rauch, P., Auth, J., Spanaus, L., Münch, J., Ruetalo, N., Schindler, M., and Morokutti-Kurz, M. (2021). Iota-Carrageenan Inhibits Replication of SARS-CoV-2 and the Respective Variants of Concern Alpha, Beta, Gamma and Delta. Int. J. Mol. Sci., 22.

Reed, 1938, A Simple method of estimating fifty per cent endpoints, Am. J. Epidemiol., 27, 493, 10.1093/oxfordjournals.aje.a118408

Corman, 2020, Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR, Eurosurveillance, 25, 2000045, 10.2807/1560-7917.ES.2020.25.3.2000045