Title:
PHARMACEUTICAL COMPOSITION FOR TREATMENT OR PREVENTION OF MYASTHENIA GRAVIS
Document Type and Number:
WIPO Patent Application WO/2022/191306
Kind Code:
A1
Abstract:
The present disclosure provides a pharmaceutical composition for the treatment or prevention of myasthenia gravis, having as an active ingredient satralizumab.
Inventors:
OZAWA TAKATOSHI (JP)
ZHOU MANDI (JP)
ITO HAJIME (JP)
YOSHIDA SHUNSUKE (JP)
SMITH JILLIAN (GB)
LENNON-CHRIMES SIAN (GB)
KRUMOVA PETRANKA (CH)
SILBER BAUMANN HANNA (CH)
ZHOU MANDI (JP)
ITO HAJIME (JP)
YOSHIDA SHUNSUKE (JP)
SMITH JILLIAN (GB)
LENNON-CHRIMES SIAN (GB)
KRUMOVA PETRANKA (CH)
SILBER BAUMANN HANNA (CH)
Application Number:
PCT/JP2022/010791
Publication Date:
September 15, 2022
Filing Date:
March 11, 2022
Export Citation:
Assignee:
CHUGAI PHARMACEUTICAL CO LTD (JP)
HOFFMANN LA ROCHE (CH)
HOFFMANN LA ROCHE (CH)
International Classes:
A61K39/395; A61P21/04; C07K16/28; C12N15/13
Domestic Patent References:
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Other References:
JONSSON DAGUR INGI, PIRSKANEN RITVA, PIEHL FREDRIK: "Beneficial effect of tocilizumab in myasthenia gravis refractory to rituximab", NEUROMUSCULAR DISORDERS, ELSEVIER LTD, GB, vol. 27, no. 6, 1 June 2017 (2017-06-01), GB , pages 565 - 568, XP055965977, ISSN: 0960-8966, DOI: 10.1016/j.nmd.2017.03.007
GILHUS NILS ERIK, SOCRATES TZARTOS, AMELIA EVOLI , JACQUELINE PALACE, TED M BURNS, JAN J G M VERSCHUUREN : "Myasthenia gravis", NAT REV DIS PRIMERS, vol. 5, no. 1, 2 May 2019 (2019-05-02), XP055965980, DOI: 10.1038/s41572-019-0079-y
GKLINOS PANAGIOTIS, PAPADOPOULOU MIRANTA, STANULOVIC VID, MITSIKOSTAS DIMOS D., PAPADOPOULOS DIMITRIOS: "Monoclonal Antibodies as Neurological Therapeutics", PHARMACEUTICALS, vol. 14, no. 2, 26 January 2021 (2021-01-26), XP055965985, DOI: 10.3390/ph14020092
ANONYMOUS: "History of Changes for Study: NCT04963270 A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Gene Myasthenia Gravis", CLINICALTRIALS.GOV, 7 July 2021 (2021-07-07), XP055965994, Retrieved from the Internet
KERTY E ET AL., EUROPEAN JOURNAL OF NEUROLOGY, vol. 21, 2014, pages 687 - 93
D I JONSSON ET AL.: "Beneficial effect of tocilizumab in myasthenia gravis refractory to rituximab", NEUROMUSCULAR DISORDERS, vol. 27, 2017, pages 565 - 568, XP055965977, DOI: 10.1016/j.nmd.2017.03.007
DENG CGOLUSZKO ETUZUN E ET AL.: "Resistance to experimental autoimmune myasthenia gravis in IL-6-deficient mice is associated with reduced germinal center formation and C3 production", J IMMUNOL., vol. 169, no. 2, 2002, pages 1077 - 83
HU YWANG JRAO J ET AL.: "Comparison of peripheral blood B cell subset ratios and B cell-related cytokine levels between ocular and generalized myasthenia gravis", INTERNATIONAL IMMUNOPHARMACOLOGY, vol. 80, 2020, pages 106130, XP086048824, DOI: 10.1016/j.intimp.2019.106130
ZHANG CJ ET AL.: "Augmentation of Circulating Follicular Helper T Cells and Their Impact on Autoreactive B Cells in Myasthenia Gravis", J IMMUNOL, vol. 197, no. 7, 1 October 2016 (2016-10-01), pages 2610 - 7
MOCCHEGIANI E ET AL.: "Different age-related effects of thymectomy in myasthenia gravis: role of thymoma, zinc, thymulin, IL-2 and IL-6", MECH AGEING DEV, vol. 117, no. 1-3, 15 August 2000 (2000-08-15), pages 79 - 91
MAURER, M.BOUGOIN, S.FEFERMAN, T. ET AL.: "IL-6 and Akt are involved in muscular pathogenesis in myasthenia gravis", ACTA NEUROPATHOL COMMUN, vol. 3, 2015, pages 1, XP021210619, DOI: 10.1186/s40478-014-0179-6
MIRIAM C. SOUROUJON ET AL.: "Regulatory T cell-based immunotherapies in experimental autoimmune myasthenia gravis", ANNALS OF THE NEW YORK ACADEMY OF SCIENCE, vol. 1274, 2012, pages 120 - 126, XP071408746, DOI: 10.1111/j.1749-6632.2012.06844.x
TAMURA, T ET AL., PROC. NATL. ACAD. SCI. USA, vol. 90, 1993, pages 11924 - 11928
HIRATA, Y ET AL., J. IMMUNOL., vol. 143, 1989, pages 2900 - 2906
YASUKAWA, K ET AL., J. BIOCHEM., vol. 108, 1990, pages 673 - 676
KEARNEY, J. F. ET AL., J. IMMUNOL, vol. 123, 1979, pages 1548 - 1550
CURRENT TOPICS IN MICROBIOLOGY AND IMMUNOLOGY, vol. 81, 1978, pages 1 - 7
KOHLER, G.MILSTEIN, C., EUR. J. IMMUNOL., vol. 6, 1976, pages 511 - 519
MARGULIES, D. H. ET AL., CELL, vol. 8, 1976, pages 405 - 415
SHULMAN, M ET AL., NATURE, vol. 276, 1978, pages 269 - 270
DE ST. GROTH, S. F. ET AL., J. IMMUNOL. METHODS, vol. 35, 1980, pages 1 - 21
TROWBRIDGE, I. S., J. EXP. MED., vol. 148, 1978, pages 313 - 323
MULLIGAN, R. C. ET AL., NATURE, vol. 277, 1979, pages 108 - 114
KOHLER, G.MILSTEIN, C., METHODS ENZYMOL., vol. 73, 1981, pages 3 - 46
MIZUSHIMA, SNAGATA S., NUCLEIC ACIDS RES, vol. 18, 1990, pages 5322
CHIRGWIN, J. M. ET AL., BIOCHEMISTRY, vol. 18, 1979, pages 5294 - 5299
CHOMCZYNSKI, P ET AL., ANAL. BIOCHEM., vol. 162, 1987, pages 156 - 159
FROHMAN, M. A. ET AL., PROC. NATL. ACAD. SCI. USA, vol. 85, 1988, pages 5879 - 5883
BELYAVSKY, A ET AL., NUCLEIC ACIDS RES, vol. 17, 1989, pages 2919 - 2932
SATO, K ET AL., CANCER RES, vol. 53, 1993, pages 851 - 856
WARD, E. S. ET AL., NATURE, vol. 341, 1989, pages 544 - 546
WARD, E. S. ET AL., FASEB J, vol. 6, 1992, pages 2422 - 2427
BETTER, M ET AL., SCIENCE, vol. 240, 1988, pages 1041 - 1043
LEI, S. P. ET AL., J. BACTERIOL., vol. 169, 1987, pages 4379 - 4383
VICKI GLASER, SPECTRUM BIOTECHNOLOGY APPLICATIONS, 1993
EBERT, K. M. ET AL., BIO/TECHNOLOGY, vol. 12, 1994, pages 699 - 702
MAEDA, S ET AL., NATURE, vol. 315, 1985, pages 592 - 594
JULIAN, K.-C. MA ET AL., EUR. J. IMMUNOL., vol. 24, 1994, pages 131 - 138
CO, M. S. ET AL., J. IMMUNOL., vol. 152, 1994, pages 2968 - 2976
PLUECKTHUN, A.SKERRA, A., METHODS IN ENZYMOLOGY, vol. 121, 1989, pages 663 - 666
BIRD, R. E. ET AL., TIBTECH, vol. 9, 1991, pages 132 - 137
ICOZ S ET AL., INT J NEUROSCI, vol. 120, no. 1, 2010, pages 71 - 5
UZAWA A. ET AL., J NEUROL, vol. 256, no. 12, 2009, pages 2082 - 4
UZAWAA ET AL., MULT SCLER, vol. 16, no. 12, 2010, pages 1443 - 52
ISHIHARA KHIRANO T, CYTOKINE & GROWTH FACTOR REVIEWS, vol. 13, no. 4-5, 2002, pages 357 - 68
ARICHA R ET AL., J AUTOIMMUN, vol. 36, no. 2, 2011, pages 135 - 41
JONSSON DI ET AL., NEUROMUSCULAR DISORDERS, vol. 27, no. 6, 2017, pages 565 - 8
BORREBAECK CAKLARRICK JW: "THERAPEUTIC MONOCLONAL ANTIBODIES", 1990, MACMILLAN PUBLISHERS LTD
VODOPIVEC ET AL., SEMIN NEROL, vol. 34, 2014, pages 467 - 78
GILHUS N ET AL., NAT REV DIS PRIMERS, vol. 5, no. 30, 2019
SANDERS DB ET AL., NEUROLOGY, vol. 87, 2016, pages 419 - 25
JARETZKI A ET AL., NEUROLOGY, vol. 55, no. 1, 2000, pages 16 - 23
EXPERT OPIN. DRUG DELIV., vol. 4, no. 4, July 2007 (2007-07-01), pages 427 - 40
"Remington's Pharmaceutical Science", 1980
LANGER ET AL., J. BIOMED. MATER. RES., vol. 15, 1981, pages 267 - 277
LANGER, CHEMTECH, vol. 12, 1982, pages 98 - 105
SIDMAN ET AL., BIOPOLYMERS, vol. 22, 1983, pages 547 - 556
WOLFE ET AL., NEUROLOGY, vol. 52, 1999, pages 1487 - 9
MUPPIDI ET AL., MUSCLE NERVE, vol. 44, 2011, pages 727 - 31
HOWARD ET AL., LANCET NEUROL, vol. 16, 2017, pages 976 - 86
TINDALL ET AL., N ENGL J MED, vol. 316, 1987, pages 719 - 24
BESINGER ET AL., NEUROLOGY, vol. 33, 1983, pages 1316 - 21
BARNETT ET AL., J NEUROMUSCULAR DISEASE, vol. 2, 2015, pages 301 - 11
BARNETT ET AL., J CLIN NEUROMUSCULAR DIS, vol. 13, 2012, pages 201 - 5
BURNS ET AL., MUSCLE AND NERVE, vol. 38, 2008, pages 957 - 63
BURNS ET AL., NEUROLOGY, vol. 74, 2010, pages 1434 - 40
CELLA ET AL., NEUROLOGY, vol. 78, 2012, pages 1860 - 7
TRAN ET AL., MUSCLE NERVE, vol. 58, 2018, pages 197 - 203
ANDERSEN ET AL., QUAL LIFE RES, vol. 28, 2019, pages 2247 - 54
COLLINS ET AL., DERMATOL CLIN, vol. 37, 2019, pages 83 - 94
GILHUS NILS ERIK, SOCRATES TZARTOS, AMELIA EVOLI , JACQUELINE PALACE, TED M BURNS, JAN J G M VERSCHUUREN : "Myasthenia gravis", NAT REV DIS PRIMERS, vol. 5, no. 1, 2 May 2019 (2019-05-02), XP055965980, DOI: 10.1038/s41572-019-0079-y
GKLINOS PANAGIOTIS, PAPADOPOULOU MIRANTA, STANULOVIC VID, MITSIKOSTAS DIMOS D., PAPADOPOULOS DIMITRIOS: "Monoclonal Antibodies as Neurological Therapeutics", PHARMACEUTICALS, vol. 14, no. 2, 26 January 2021 (2021-01-26), XP055965985, DOI: 10.3390/ph14020092
ANONYMOUS: "History of Changes for Study: NCT04963270 A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Gene Myasthenia Gravis", CLINICALTRIALS.GOV, 7 July 2021 (2021-07-07), XP055965994, Retrieved from the Internet
KERTY E ET AL., EUROPEAN JOURNAL OF NEUROLOGY, vol. 21, 2014, pages 687 - 93
D I JONSSON ET AL.: "Beneficial effect of tocilizumab in myasthenia gravis refractory to rituximab", NEUROMUSCULAR DISORDERS, vol. 27, 2017, pages 565 - 568, XP055965977, DOI: 10.1016/j.nmd.2017.03.007
DENG CGOLUSZKO ETUZUN E ET AL.: "Resistance to experimental autoimmune myasthenia gravis in IL-6-deficient mice is associated with reduced germinal center formation and C3 production", J IMMUNOL., vol. 169, no. 2, 2002, pages 1077 - 83
HU YWANG JRAO J ET AL.: "Comparison of peripheral blood B cell subset ratios and B cell-related cytokine levels between ocular and generalized myasthenia gravis", INTERNATIONAL IMMUNOPHARMACOLOGY, vol. 80, 2020, pages 106130, XP086048824, DOI: 10.1016/j.intimp.2019.106130
ZHANG CJ ET AL.: "Augmentation of Circulating Follicular Helper T Cells and Their Impact on Autoreactive B Cells in Myasthenia Gravis", J IMMUNOL, vol. 197, no. 7, 1 October 2016 (2016-10-01), pages 2610 - 7
MOCCHEGIANI E ET AL.: "Different age-related effects of thymectomy in myasthenia gravis: role of thymoma, zinc, thymulin, IL-2 and IL-6", MECH AGEING DEV, vol. 117, no. 1-3, 15 August 2000 (2000-08-15), pages 79 - 91
MAURER, M.BOUGOIN, S.FEFERMAN, T. ET AL.: "IL-6 and Akt are involved in muscular pathogenesis in myasthenia gravis", ACTA NEUROPATHOL COMMUN, vol. 3, 2015, pages 1, XP021210619, DOI: 10.1186/s40478-014-0179-6
MIRIAM C. SOUROUJON ET AL.: "Regulatory T cell-based immunotherapies in experimental autoimmune myasthenia gravis", ANNALS OF THE NEW YORK ACADEMY OF SCIENCE, vol. 1274, 2012, pages 120 - 126, XP071408746, DOI: 10.1111/j.1749-6632.2012.06844.x
TAMURA, T ET AL., PROC. NATL. ACAD. SCI. USA, vol. 90, 1993, pages 11924 - 11928
HIRATA, Y ET AL., J. IMMUNOL., vol. 143, 1989, pages 2900 - 2906
YASUKAWA, K ET AL., J. BIOCHEM., vol. 108, 1990, pages 673 - 676
KEARNEY, J. F. ET AL., J. IMMUNOL, vol. 123, 1979, pages 1548 - 1550
CURRENT TOPICS IN MICROBIOLOGY AND IMMUNOLOGY, vol. 81, 1978, pages 1 - 7
KOHLER, G.MILSTEIN, C., EUR. J. IMMUNOL., vol. 6, 1976, pages 511 - 519
MARGULIES, D. H. ET AL., CELL, vol. 8, 1976, pages 405 - 415
SHULMAN, M ET AL., NATURE, vol. 276, 1978, pages 269 - 270
DE ST. GROTH, S. F. ET AL., J. IMMUNOL. METHODS, vol. 35, 1980, pages 1 - 21
TROWBRIDGE, I. S., J. EXP. MED., vol. 148, 1978, pages 313 - 323
MULLIGAN, R. C. ET AL., NATURE, vol. 277, 1979, pages 108 - 114
KOHLER, G.MILSTEIN, C., METHODS ENZYMOL., vol. 73, 1981, pages 3 - 46
MIZUSHIMA, SNAGATA S., NUCLEIC ACIDS RES, vol. 18, 1990, pages 5322
CHIRGWIN, J. M. ET AL., BIOCHEMISTRY, vol. 18, 1979, pages 5294 - 5299
CHOMCZYNSKI, P ET AL., ANAL. BIOCHEM., vol. 162, 1987, pages 156 - 159
FROHMAN, M. A. ET AL., PROC. NATL. ACAD. SCI. USA, vol. 85, 1988, pages 5879 - 5883
BELYAVSKY, A ET AL., NUCLEIC ACIDS RES, vol. 17, 1989, pages 2919 - 2932
SATO, K ET AL., CANCER RES, vol. 53, 1993, pages 851 - 856
WARD, E. S. ET AL., NATURE, vol. 341, 1989, pages 544 - 546
WARD, E. S. ET AL., FASEB J, vol. 6, 1992, pages 2422 - 2427
BETTER, M ET AL., SCIENCE, vol. 240, 1988, pages 1041 - 1043
LEI, S. P. ET AL., J. BACTERIOL., vol. 169, 1987, pages 4379 - 4383
VICKI GLASER, SPECTRUM BIOTECHNOLOGY APPLICATIONS, 1993
EBERT, K. M. ET AL., BIO/TECHNOLOGY, vol. 12, 1994, pages 699 - 702
MAEDA, S ET AL., NATURE, vol. 315, 1985, pages 592 - 594
JULIAN, K.-C. MA ET AL., EUR. J. IMMUNOL., vol. 24, 1994, pages 131 - 138
CO, M. S. ET AL., J. IMMUNOL., vol. 152, 1994, pages 2968 - 2976
PLUECKTHUN, A.SKERRA, A., METHODS IN ENZYMOLOGY, vol. 121, 1989, pages 663 - 666
BIRD, R. E. ET AL., TIBTECH, vol. 9, 1991, pages 132 - 137
ICOZ S ET AL., INT J NEUROSCI, vol. 120, no. 1, 2010, pages 71 - 5
UZAWA A. ET AL., J NEUROL, vol. 256, no. 12, 2009, pages 2082 - 4
UZAWAA ET AL., MULT SCLER, vol. 16, no. 12, 2010, pages 1443 - 52
ISHIHARA KHIRANO T, CYTOKINE & GROWTH FACTOR REVIEWS, vol. 13, no. 4-5, 2002, pages 357 - 68
ARICHA R ET AL., J AUTOIMMUN, vol. 36, no. 2, 2011, pages 135 - 41
JONSSON DI ET AL., NEUROMUSCULAR DISORDERS, vol. 27, no. 6, 2017, pages 565 - 8
BORREBAECK CAKLARRICK JW: "THERAPEUTIC MONOCLONAL ANTIBODIES", 1990, MACMILLAN PUBLISHERS LTD
VODOPIVEC ET AL., SEMIN NEROL, vol. 34, 2014, pages 467 - 78
GILHUS N ET AL., NAT REV DIS PRIMERS, vol. 5, no. 30, 2019
SANDERS DB ET AL., NEUROLOGY, vol. 87, 2016, pages 419 - 25
JARETZKI A ET AL., NEUROLOGY, vol. 55, no. 1, 2000, pages 16 - 23
EXPERT OPIN. DRUG DELIV., vol. 4, no. 4, July 2007 (2007-07-01), pages 427 - 40
"Remington's Pharmaceutical Science", 1980
LANGER ET AL., J. BIOMED. MATER. RES., vol. 15, 1981, pages 267 - 277
LANGER, CHEMTECH, vol. 12, 1982, pages 98 - 105
SIDMAN ET AL., BIOPOLYMERS, vol. 22, 1983, pages 547 - 556
WOLFE ET AL., NEUROLOGY, vol. 52, 1999, pages 1487 - 9
MUPPIDI ET AL., MUSCLE NERVE, vol. 44, 2011, pages 727 - 31
HOWARD ET AL., LANCET NEUROL, vol. 16, 2017, pages 976 - 86
TINDALL ET AL., N ENGL J MED, vol. 316, 1987, pages 719 - 24
BESINGER ET AL., NEUROLOGY, vol. 33, 1983, pages 1316 - 21
BARNETT ET AL., J NEUROMUSCULAR DISEASE, vol. 2, 2015, pages 301 - 11
BARNETT ET AL., J CLIN NEUROMUSCULAR DIS, vol. 13, 2012, pages 201 - 5
BURNS ET AL., MUSCLE AND NERVE, vol. 38, 2008, pages 957 - 63
BURNS ET AL., NEUROLOGY, vol. 74, 2010, pages 1434 - 40
CELLA ET AL., NEUROLOGY, vol. 78, 2012, pages 1860 - 7
TRAN ET AL., MUSCLE NERVE, vol. 58, 2018, pages 197 - 203
ANDERSEN ET AL., QUAL LIFE RES, vol. 28, 2019, pages 2247 - 54
COLLINS ET AL., DERMATOL CLIN, vol. 37, 2019, pages 83 - 94
Attorney, Agent or Firm:
HARUNA, Masao et al. (JP)
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