Medical and Scientific Publications

Many of the nonconfidential advances in our premier research and development pipeline are shared through an extensive list of peer-reviewed publications and posters presented at international conferences.

Narsoplimab (OMS721) Publications:

Narsoplimab is an investigational product not approved by any regulatory agency.

2022

Narsoplimab treatment for recurrent IgA nephropathy stabilized eGFR and proteinuria

Storrar J, Rainone F, Middleton R, Barratt J. J Am Soc Nephrol. 2022;33:195.

View abstract

Use of narsoplimab in a paediatric patient with IgA nephropathy

Oni L, McCormack V, Jones CA, Barratt J. J Am Soc Nephrol. 2022;33:959.

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C5b-9 and MASP2 deposition in skin and bone marrow microvasculature characterize hematopoietic stem cell transplant-associated thrombotic microangiopathy

Elhadad S, Chadburn A, Magro C, et al. Bone Marrow Transplant. 2022;57(9):1445-1447.

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Premortem skin biopsy assessing microthrombi, interferon type I antiviral and regulatory proteins, and complement deposition correlates with coronavirus disease 2019 clinical stage

Laurence J, Nuovo G, Racine-Brzostek SE, et al. Am J Pathol. 2022;192(9)1282-1294.

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Inhibition of the lectin pathway of complement ameliorates hypocomplementemia and restores serum bactericidal activity in patients with severe COVID-19

Lynch NJ, Chan ACY, Ali YM, et al. Clin Transl Med. 2022;12(7):e980.

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Narsoplimab, a mannan-binding lectin-associated serine protease-2 inhibitor, for the treatment of adult hematopoietic stem-cell transplantation–associated thrombotic microangiopathy

Khaled SK, Claes K, Goh YT, et al. J Clin Oncol. 2022;40(22):2447-2457.

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Secondary complement deficiency impairs anti-microbial immunity to Klebsiella pneumoniae and Staphylococcus aureus during severe acute COVID-19

Ali YM, Lynch NJ, Khatri P, et al. Front Immunol. 2022;13:841759.

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Compassionate use narsoplimab to treat transplant associated thrombotic microangiopathy in a pediatric patient with multi-organ failure

Schoettler M, Bryson E, Deeb L, et al. Bone Marrow Transplant. 2022;57(suppl 1):350.

View abstract

Lectin pathway inhibitor for transplant-associated thrombotic microangiopathy

Ganatra P, Kakunje M, Mishra V, Pandrowala A, Hiwarkar P. Bone Marrow Transplant. 2022;57(suppl 1):349.

View abstract

Trial design: Phase 3 randomized, double-blind, placebo-controlled study of narsoplimab safety and efficacy in IgA nephropathy (ARTEMIS-IGAN)

Lafayette R, Rovin B, Floege J, et al. Kidney Int Rep. 2022;7(2):S57.

View abstract

2021

Role of the lectin pathway of complement in hematopoietic stem cell transplantation-associated endothelial injury and thrombotic microangiopathy

Gavriilaki E, Ho VT, Schwaeble W, et al. Exp Hematol Oncol. 2021;10:57.

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Characterization of narsoplimab, a selective inhibitor of lectin pathway-mediated complement activation and thrombosis

Dudler T, Yaseen S, Freeman J, et al. Molecular Immunology. 2021;141:145.

View abstract

Real world use of narsoplimab in a case of severe HSCT-TMA

Pantin JM, Billy A. Blood. 2021;138(suppl 1):4862.

View abstract

Long-term Phase 2 efficacy of the MASP-2 inhibitor narsoplimab for treatment of severe IgA nephropathy

Lafayette R, Carroll K, Barratt J. J Am Soc Nephrol. 2021;32:B10.

View abstract

Reduction of urinary levels of lectin pathway complement components in an IgA vasculitis patient after MASP-2 inhibition with narsoplimab

Pérez-Alós L, Scionti K, Molyneux K, Barratt J, Garred P. J Am Soc Nephrol. 2021;32:498.

View abstract

Lectin pathway mediates complement activation by SARS-CoV-2 proteins

Ali YM, Ferrari M, Lynch NJ, et al. Front Immunol. 2021;12:714511.

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Narsoplimab (OMS721) treatment contributes to improvements in organ function in adult patients with high-risk transplant-associated thrombotic microangiopathy

Perales M, Cairo M, Duarte R, et al. HemaSphere. 2021;5(suppl 2):79.

View abstract

Narsoplimab (OMS721), a MASP-2 inhibitor, for the treatment of adult hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA): Subgroup analyses

Rambaldi A, Claes K, Goh YT, et al. Bone Marrow Transplant. 2021;56:147-149.

View abstract

Clinical pharmacology and population pharmacokinetic/pharmacodynamic modeling of lectin pathway inhibition by narsoplimab (OMS721)

Pullman W, Facius A, Lahu G, Smyth B. Bone Marrow Transplant. 2021;56:300-301.

View abstract

In acute HSCT/BMT-TMA the activation of the lectin pathway induces C5b-9 formation on endothelial cells and favors microvascular thrombosis

Galbusera M, Gastoldi S, Noris M, Bresin E, Benigni A, Remuzzi G. Bone Marrow Transplant. 2021;56:295-297.

View abstract

Narsoplimab (OMS721), a MASP-2 inhibitor, for the treatment of adult hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA)

Khaled SK, Boelens JJ, Cairo MS, et al. Transplantation and Cellular Therapy. 2021;27(3):S24-S26.

View abstract

MASP2 levels are elevated in thrombotic microangiopathies: association with microvascular endothelial cell injury and suppression by anti-MASP2 antibody narsoplimab

Elhadad S, Chapin J, Copertino D, Van Besien K, Ahamed J, Laurence J. Clin Exp Immunol. 2021;203(1):96-104.

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2020

Development of pharmacodynamic assays to assess ex vivo MASP-2 inhibition and their use to characterize the pharmacodynamics of narsoplimab (OMS721) in humans and monkeys

Freeman J, Cummings J, Chuidian M, Dudler T. Blood. 2020;136(suppl 1):26-27.

View abstract

Endothelial injury and thrombotic microangiopathy in COVID-19: Treatment with the lectin-pathway inhibitor narsoplimab

Rambaldi A, Gritti G, Micò MC, et al. Immunobiology. 2020;225(6):152001.

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Safety, tolerability, and effect of narsoplimab (OMS721), a novel MASP-2 inhibitor for the treatment of IgA nephropathy

Lafayette R, Rovin B, Floege J, et al. Kidney Int Rep. 2020;5(11):2032-2041.

View on PubMed

Inhibition of the lectin pathway of the complement system as a novel approach in the management of IgA vasculitis-associated nephritis

Selvaskandan H, Cheung CK, Dormer J, et al. Nephron. 2020;144(9):453-458.

View on PubMed

Narsoplimab (OMS721) for the treatment of adult hematopoietic stem cell transplant-associated thrombotic microangiopathy

Rambaldi A, Smith M, Whitaker S, Khaled S. HemaSphere. 2020;4(suppl 1):92.

View abstract

MASP-2 inhibition as a potential strategy for the management of IgA nephropathy

Barratt J, Lafayette R. Drugs of the Future. 2020;45(6):389-396.

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2019

MASP-2 levels following allogeneic hematopoietic stem cell transplantation in adults: correlation with development of a thrombotic microangiopathy and implications for therapy with anti-complement agents

Elhadad S, Van Biesen K, Chapin J, Ahamed J, Laurence J. Blood. 2019;134(suppl 1):3305.

View Abstract

Absence of the lectin activation pathway of complement ameliorates proteinuria-induced renal injury

Alghadban S, Kenawy HI, Dudler T, Schwaeble WJ, Bunskill NJ. Front Immunol. 2019;10:2238.

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Interim results from an ongoing phase 2 study evaluating the use of a MASP-2 inhibitor for the treatment of IgA nephropathy

Barratt J, Leifke E, Whitaker S, DeTulleo L, Lafayette R. Nephrology Dialysis Transplant. 2019;34(suppl 1):111.

View Abstract

2018

Cardioprotection by an anti-MASP-2 antibody in a murine model of myocardial infarction

Clark JE, Dudler T, Marber MS, Schwaeble W. Open Heart. 2018;5(1):e000652.

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Improved survival following OMS721 treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HCT-TMA)

Rambaldi A, Khaled S, Smith M, et al. HemaSphere. 2018;2(suppl 1):312-313.

View Abstract

2017

The effect of OMS721 on proteinuria in patients with IgA nephropathy

Block G, Whitaker S. Nephrology Dialysis Transplant. 2017;32(suppl 3):143.

View Abstract

Maintenance of remission following completion of OMS721 treatment in Patients with IgA nephropathy (IgAN)

Block G, Whitaker S. J Am Soc Nephrol. 2017;28:749-750.

View Abstract

Effective treatment of GvHD-associated transplant-associated microangiopathy with a novel inhibitor of the lectin pathway of complement

Caprioli C, Grassi A, Micò C, Rambaldi A. Presented at: EBMT Transplant Complications Working Party – Crash Course on Diagnosis and Treatment of Noninfectious Complications after HCT: October 19-20, 2017; Granada, Spain.

Early results of a phase 2 study using OMS721 in patients with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HCT-TMA)

Khaled SK, Kwong YL, Smith M, Metjian A, Whitaker S. Biol Blood Marrow Transplant. 2017;23:S282-S283.

View Abstract

Dose-finding clinical trial of OMS721 for the treatment of atypical hemolytic uremic syndrome (aHUS) – stage 1 results

Nowicki M, Wiecek A, Massart A, Weekers L, Whitaker S, Miglinas M. Presented at: World Congress of Nephrology (WCN); April 21-25, 2017; Mexico City, Mexico.

Lectin pathway effector enzyme mannan-binding lectin-associated serine protease-2 can activate native complement C3 in absence of C4 and/or C2

Yaseen S, Demopulos G, Dudler T, et al. FASEB J. 2017;31(5):2210-2219.

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Resolution of acute kidney injury secondary to TA-TMA by the anti-MASP-2 monoclonal antibody OMS721 in a pediatric HSCT recipient

Zecca M, Comoli P, Mina T, et al. Bone Marrow Transplant. 2017;52:S309.

View abstract

2016

Mannan binding lectin-associated serine protease-2 (MASP-2) critically contributes to post-ischemic brain injury independent of MASP-1

Orsini F, Chrysanthou E, Dudler T, et al. J Neuroinflammation. 2016;13(1):213.

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2014

Mannan-binding lectin-associated serine protease 2 is critical for the development of renal ischemia reperfusion injury and mediates tissue injury in the absence of complement C4

Asgari E, Farrar CA, Lynch N, et al. FASEB J. 2014;28(9):3996-4003.

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2012

The lectin pathway of complement activation is a critical component of the innate immune response to pneumococcal infection

Ali YM, Lynch NJ, Haleem KS, et al. PLoS Pathog. 2012;8:e1002793.

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2011

Targeting of mannan-binding lectin-associated serine protease-2 confers protection from myocardial and gastrointestinal ischemia/reperfusion injury

Schwaeble WJ, Lynch NJ, Clark JE, et al. Proc Natl Acad Sci USA. 2011;108(18):7523-7528.

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2010

Activation of mannan-binding lectin-associated serine proteases leads to generation of a fibrin clot

Gulla KC1, Gupta K, Krarup A, et al. Immunology. 2010;129(4):482-495.

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Other Publications:

In vivo inhibition of alternative pathway activity via MASP-3 inhibitor OMS906

Cummings WJ, Li Y, Shaffer K, Freeman J, Yabuki M, Dudler T. Molecular Immunology. 2022;150:145.

View abstract

MASP-2 and MASP-3 inhibitors block complement activation, inflammation, and microvascular stasis in a murine model of vaso-occlusion in sickle cell disease

Belcher JD, Nguyen J, Chen C, et al. Transl Res. 2022;249:1-12.

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Selective inhibition of phosphodiesterase 7 enzymes reduces motivation for nicotine use through modulation of mesolimbic dopaminergic transmission

Ciccocioppo R, de Guglielmo G, Li H, et al. J Neurosci. 2021;41(28):6128-6143.

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PPARγ activation attenuates opioid consumption and modulates mesolimbic dopamine transmission

de Guglielmo G, Melis M, De Luca MA, et al. Neuropsychopharmacology. 2015;40(4):927-937.

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Selection of targeted mutants from a library of randomly mutagenized ES cells

Horie K, Gaitanaris G, Gragerov A. Methods Mol Biol. 2011;693:283-294.

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An inducible and reversible mouse genetic rescue system

Zeng H, Horie K, Madisen L, et al. PLoS Genet. 2008;4(5):e1000069.

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Neuromedin U receptor 2-deficient mice display differential responses in sensory perception, stress, and feeding

Zeng H, Gragerov A, Hohmann JG, et al. Mol Cell Biol. 2006;26(24):9352-9363.

View on PubMed

Medical and Scientific Publications

Narsoplimab (OMS721) Publications:

Narsoplimab is an investigational product not approved by any regulatory agency.

2022

Narsoplimab treatment for recurrent IgA nephropathy stabilized eGFR and proteinuria

Use of narsoplimab in a paediatric patient with IgA nephropathy

C5b-9 and MASP2 deposition in skin and bone marrow microvasculature characterize hematopoietic stem cell transplant-associated thrombotic microangiopathy

Premortem skin biopsy assessing microthrombi, interferon type I antiviral and regulatory proteins, and complement deposition correlates with coronavirus disease 2019 clinical stage

Inhibition of the lectin pathway of complement ameliorates hypocomplementemia and restores serum bactericidal activity in patients with severe COVID-19

Narsoplimab, a mannan-binding lectin-associated serine protease-2 inhibitor, for the treatment of adult hematopoietic stem-cell transplantation–associated thrombotic microangiopathy

Secondary complement deficiency impairs anti-microbial immunity to Klebsiella pneumoniae and Staphylococcus aureus during severe acute COVID-19

Compassionate use narsoplimab to treat transplant associated thrombotic microangiopathy in a pediatric patient with multi-organ failure

Lectin pathway inhibitor for transplant-associated thrombotic microangiopathy

Trial design: Phase 3 randomized, double-blind, placebo-controlled study of narsoplimab safety and efficacy in IgA nephropathy (ARTEMIS-IGAN)

2021

Role of the lectin pathway of complement in hematopoietic stem cell transplantation-associated endothelial injury and thrombotic microangiopathy

Characterization of narsoplimab, a selective inhibitor of lectin pathway-mediated complement activation and thrombosis

Real world use of narsoplimab in a case of severe HSCT-TMA

Long-term Phase 2 efficacy of the MASP-2 inhibitor narsoplimab for treatment of severe IgA nephropathy

Reduction of urinary levels of lectin pathway complement components in an IgA vasculitis patient after MASP-2 inhibition with narsoplimab

Lectin pathway mediates complement activation by SARS-CoV-2 proteins

Narsoplimab (OMS721) treatment contributes to improvements in organ function in adult patients with high-risk transplant-associated thrombotic microangiopathy

Narsoplimab (OMS721), a MASP-2 inhibitor, for the treatment of adult hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA): Subgroup analyses

Clinical pharmacology and population pharmacokinetic/pharmacodynamic modeling of lectin pathway inhibition by narsoplimab (OMS721)

In acute HSCT/BMT-TMA the activation of the lectin pathway induces C5b-9 formation on endothelial cells and favors microvascular thrombosis

Narsoplimab (OMS721), a MASP-2 inhibitor, for the treatment of adult hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA)

MASP2 levels are elevated in thrombotic microangiopathies: association with microvascular endothelial cell injury and suppression by anti-MASP2 antibody narsoplimab

2020

Development of pharmacodynamic assays to assess ex vivo MASP-2 inhibition and their use to characterize the pharmacodynamics of narsoplimab (OMS721) in humans and monkeys

Endothelial injury and thrombotic microangiopathy in COVID-19: Treatment with the lectin-pathway inhibitor narsoplimab

Safety, tolerability, and effect of narsoplimab (OMS721), a novel MASP-2 inhibitor for the treatment of IgA nephropathy

Inhibition of the lectin pathway of the complement system as a novel approach in the management of IgA vasculitis-associated nephritis

Narsoplimab (OMS721) for the treatment of adult hematopoietic stem cell transplant-associated thrombotic microangiopathy

MASP-2 inhibition as a potential strategy for the management of IgA nephropathy

2019

MASP-2 levels following allogeneic hematopoietic stem cell transplantation in adults: correlation with development of a thrombotic microangiopathy and implications for therapy with anti-complement agents

Absence of the lectin activation pathway of complement ameliorates proteinuria-induced renal injury

Interim results from an ongoing phase 2 study evaluating the use of a MASP-2 inhibitor for the treatment of IgA nephropathy

2018

Cardioprotection by an anti-MASP-2 antibody in a murine model of myocardial infarction

Improved survival following OMS721 treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HCT-TMA)

2017

The effect of OMS721 on proteinuria in patients with IgA nephropathy

Maintenance of remission following completion of OMS721 treatment in Patients with IgA nephropathy (IgAN)

Effective treatment of GvHD-associated transplant-associated microangiopathy with a novel inhibitor of the lectin pathway of complement

Early results of a phase 2 study using OMS721 in patients with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HCT-TMA)

Dose-finding clinical trial of OMS721 for the treatment of atypical hemolytic uremic syndrome (aHUS) – stage 1 results

Lectin pathway effector enzyme mannan-binding lectin-associated serine protease-2 can activate native complement C3 in absence of C4 and/or C2

Resolution of acute kidney injury secondary to TA-TMA by the anti-MASP-2 monoclonal antibody OMS721 in a pediatric HSCT recipient

2016

Mannan binding lectin-associated serine protease-2 (MASP-2) critically contributes to post-ischemic brain injury independent of MASP-1

2014

Mannan-binding lectin-associated serine protease 2 is critical for the development of renal ischemia reperfusion injury and mediates tissue injury in the absence of complement C4

2012

The lectin pathway of complement activation is a critical component of the innate immune response to pneumococcal infection

2011

Targeting of mannan-binding lectin-associated serine protease-2 confers protection from myocardial and gastrointestinal ischemia/reperfusion injury

2010

Activation of mannan-binding lectin-associated serine proteases leads to generation of a fibrin clot

Other Publications:

In vivo inhibition of alternative pathway activity via MASP-3 inhibitor OMS906

MASP-2 and MASP-3 inhibitors block complement activation, inflammation, and microvascular stasis in a murine model of vaso-occlusion in sickle cell disease

Selective inhibition of phosphodiesterase 7 enzymes reduces motivation for nicotine use through modulation of mesolimbic dopaminergic transmission

PPARγ activation attenuates opioid consumption and modulates mesolimbic dopamine transmission

Selection of targeted mutants from a library of randomly mutagenized ES cells

An inducible and reversible mouse genetic rescue system

Neuromedin U receptor 2-deficient mice display differential responses in sensory perception, stress, and feeding

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