Title:
SERUM NEUROFILAMENT PROTEIN FOR GUIDING THERAPEUTIC INTERVENTION IN MULTIPLE SCLEROSIS
Document Type and Number:
WIPO Patent Application WO/2020/061355
Kind Code:
A3
Abstract:
In one aspect, the invention provides a method for alleviating symptoms in a patient with multiple sclerosis, comprising administering an efficacious therapeutic that is efficacious to the patient, the efficacious therapeutic, when administered to the patient, resulting in a level of a neurofilament protein in serum of the patient that is lower than an amount equivalent to 16 pg serum neurofilament light chain per ml serum or lower than a level of neurofilament protein in a patient with multiple sclerosis not administered the therapeutic. In some embodiments, the patient is currently being administered with or has formerly been administered with either a non-efficacious therapeutic or a therapeutic that is different than the efficacious therapeutic.
Inventors:
PLAVINA TATIANA (US)
RUDICK RICHARD ALAN (US)
KIESEIER BERND CHRISTOPH (US)
SANGURDEKAR DIPEN (US)
DE MOOR CARL (US)
FISHER ELIZABETH (US)
SINGH CAROL MARGARET (US)
RUDICK RICHARD ALAN (US)
KIESEIER BERND CHRISTOPH (US)
SANGURDEKAR DIPEN (US)
DE MOOR CARL (US)
FISHER ELIZABETH (US)
SINGH CAROL MARGARET (US)
Application Number:
PCT/US2019/051992
Publication Date:
July 23, 2020
Filing Date:
September 19, 2019
Export Citation:
Assignee:
BIOGEN MA INC (US)
International Classes:
A61K39/395; A61P25/28
Other References:
RALF A LINKER ET AL: "Innovative monoclonal antibody therapies in multiple sclerosis", THERAPEUTIC ADVANCES IN NEUROLOGICAL DISORDERS, SAGE PUBLICATIONS LTD, UNITED KINGDOM, vol. 1, no. 1, 1 July 2008 (2008-07-01), pages 33 - 42, XP002617116, ISSN: 1756-2856, DOI: 10.1177/1756285608093945
KUHLE J ET AL: "Neurofilament light and heavy subunits compared as therapeutic biomarkers in multiple sclerosis", ACTA NEUROLOGICA SCANDINAVICA, vol. 128, no. 6, December 2013 (2013-12-01), pages E33 - E36, XP002796141
NOVAKOVA LENKA ET AL: "Reduced cerebrospinal fluid concentrations of oxysterols in response to natalizumab treatment of relapsing remitting multiple sclerosis", JOURNAL OF NEUROLOGICAL SCIENCES, ELSEVIER SCIENTIFIC PUBLISHING CO, AMSTERDAM, NL, vol. 358, no. 1, 29 August 2015 (2015-08-29), pages 201 - 206, XP029321597, ISSN: 0022-510X, DOI: 10.1016/J.JNS.2015.08.1537
AMOR SANDRA ET AL: "Neurofilament light antibodies in serum reflect response to natalizumab treatment in multiple sclerosis", MULTIPLE SCLEROSIS JOURNAL, vol. 20, no. 10, September 2014 (2014-09-01), pages 1355 - 1362, XP009517420
LENKA NOVAKOVA ET AL: "Monitoring disease activity in multiple sclerosis using serum neurofilament light protein", NEUROLOGY, vol. 89, no. 22, 28 November 2017 (2017-11-28), US, pages 2230 - 2237, XP055590407, ISSN: 0028-3878, DOI: 10.1212/WNL.0000000000004683
GIULIO DISANTO ET AL: "Serum Neurofilament light: A biomarker of neuronal damage in multiple sclerosis : Serum NfL as a Biomarker in MS", ANNALS OF NEUROLOGY., vol. 81, no. 6, 1 June 2017 (2017-06-01), BOSTON, US, pages 857 - 870, XP055590411, ISSN: 0364-5134, DOI: 10.1002/ana.24954
GUNNARSSON MARTIN ET AL: "Axonal Damage in Relapsing Multiple Sclerosis is Markedly Reduced by Natalizumab", ANNALS OF NEUROLOGY, vol. 69, no. 1, January 2011 (2011-01-01), pages 83 - 89, XP002796142
CALABRESI P A: "Serum neurofilament light (NFL): Towards a blood test for prognosis and disease/treatment monitoring in multiple sclerosis patients", NEUROLOGY 20180401 LIPPINCOTT WILLIAMS AND WILKINS NLD, vol. 90, no. 15, Supplement 1, 1 April 2018 (2018-04-01), XP009517434, ISSN: 1526-632X
KUHLE J ET AL: "Neurofilament light and heavy subunits compared as therapeutic biomarkers in multiple sclerosis", ACTA NEUROLOGICA SCANDINAVICA, vol. 128, no. 6, December 2013 (2013-12-01), pages E33 - E36, XP002796141
NOVAKOVA LENKA ET AL: "Reduced cerebrospinal fluid concentrations of oxysterols in response to natalizumab treatment of relapsing remitting multiple sclerosis", JOURNAL OF NEUROLOGICAL SCIENCES, ELSEVIER SCIENTIFIC PUBLISHING CO, AMSTERDAM, NL, vol. 358, no. 1, 29 August 2015 (2015-08-29), pages 201 - 206, XP029321597, ISSN: 0022-510X, DOI: 10.1016/J.JNS.2015.08.1537
AMOR SANDRA ET AL: "Neurofilament light antibodies in serum reflect response to natalizumab treatment in multiple sclerosis", MULTIPLE SCLEROSIS JOURNAL, vol. 20, no. 10, September 2014 (2014-09-01), pages 1355 - 1362, XP009517420
LENKA NOVAKOVA ET AL: "Monitoring disease activity in multiple sclerosis using serum neurofilament light protein", NEUROLOGY, vol. 89, no. 22, 28 November 2017 (2017-11-28), US, pages 2230 - 2237, XP055590407, ISSN: 0028-3878, DOI: 10.1212/WNL.0000000000004683
GIULIO DISANTO ET AL: "Serum Neurofilament light: A biomarker of neuronal damage in multiple sclerosis : Serum NfL as a Biomarker in MS", ANNALS OF NEUROLOGY., vol. 81, no. 6, 1 June 2017 (2017-06-01), BOSTON, US, pages 857 - 870, XP055590411, ISSN: 0364-5134, DOI: 10.1002/ana.24954
GUNNARSSON MARTIN ET AL: "Axonal Damage in Relapsing Multiple Sclerosis is Markedly Reduced by Natalizumab", ANNALS OF NEUROLOGY, vol. 69, no. 1, January 2011 (2011-01-01), pages 83 - 89, XP002796142
CALABRESI P A: "Serum neurofilament light (NFL): Towards a blood test for prognosis and disease/treatment monitoring in multiple sclerosis patients", NEUROLOGY 20180401 LIPPINCOTT WILLIAMS AND WILKINS NLD, vol. 90, no. 15, Supplement 1, 1 April 2018 (2018-04-01), XP009517434, ISSN: 1526-632X
Attorney, Agent or Firm:
BRENNAN, Jack (US)
Download PDF: