DK2525812T3 - Middel mod antikoagulant. - Google Patents

Middel mod antikoagulant. Download PDF

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Publication number
DK2525812T3
DK2525812T3 DK11703410.8T DK11703410T DK2525812T3 DK 2525812 T3 DK2525812 T3 DK 2525812T3 DK 11703410 T DK11703410 T DK 11703410T DK 2525812 T3 DK2525812 T3 DK 2525812T3
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ser
dabigatran
val
leu
thr
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DK11703410.8T
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Inventor
Ryn Joanne Van
John Edward Park
Norbert Hauel
Ulrich Kunz
Tobias Litzenburger
Keith Canada
Sanjaya Singh
Alisa Waterman
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Boehringer Ingelheim Int
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/44—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material not provided for elsewhere, e.g. haptens, metals, DNA, RNA, amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39583—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials not provided for elsewhere, e.g. haptens, coenzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A61P39/02—Antidotes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/86—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood coagulating time or factors, or their receptors
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/54—F(ab')2
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/569—Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622—Single chain antibody (scFv)
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/626—Diabody or triabody
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2500/00—Screening for compounds of potential therapeutic value
    • G01N2500/02—Screening involving studying the effect of compounds C on the interaction between interacting molecules A and B (e.g. A = enzyme and B = substrate for A, or A = receptor and B = ligand for the receptor)
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2500/00—Screening for compounds of potential therapeutic value
    • G01N2500/10—Screening for compounds of potential therapeutic value involving cells

Claims (20)

1. Antistofmolekyle med bindingsspecificitet for dabigatran, som omfatter et variabelt tungkædedomæne med en CDR1 ifølge SEQ ID NO: 1, en CDR2 ifølge SEQ ID N0:7, en CDR3 ifølge SEQ ID N0:10 og et variabelt letkædedomæne med en CDR1 ifølge SEQ ID N0:13, en CDR2 ifølge SEQ ID N0:14 og en CDR3 ifølge SEQ ID N0:15.
2. Antistofmolekyle ifølge krav 1, som omfatter et variabelt tungkædedomæne ifølge SEQ ID N0:24 og et variabelt letkædedomæne ifølge SEQ ID N0:27.
3. Antistofmolekyle ifølge et hvilket som helst af de foregående krav, som er et mo-noklonalt antistof, et humant antistof, et humaniseret antistof, et kimært antistof, et fragment af et antistof, navnlig et Fab-, Fab'- eller F(ab')2-fragment, et enkeltkædeantistof, i særdeleshed et enkeltkædet variabelt fragment (scFv), et lille modulært immunfarmakon (SMIP) eller et dia-antistof.
4. Antistofmolekyle ifølge krav 3, som er et scFv, hvor det variable tungkædedomæne og det variable letkædedomæne er forbundet til hinanden med et forbindelsespeptid udvalgt fra gruppen bestående af SEQ ID N0:28, SEQ ID N0:29, SEQ ID N0:30 og SEQ ID N0:31.
5. Antistofmolekyle ifølge krav 3 med en tung kæde omfattende SEQ ID N0:40 og en let kæde omfattende SEQ ID N0:35.
6. Antistof ifølge krav 3, som er et Fab-molekyle med et Fd-fragment omfattende SEQ ID N0:36 eller SEQ ID N0:41 og en let kæde omfattende SEQ ID N0:37.
7. Antistof ifølge krav 6 med et Fd-fragment omfattende SEQ ID N0:36 og en let kæde omfattende SEQ ID N0:37.
8. Antistofmolekyle ifølge et hvilket som helst af de foregående krav til anvendelse som lægemiddel.
9. Antistofmolekyle ifølge et hvilket som helst af de foregående krav til anvendelse som et modmiddel mod dabigatran- eller dabigatranetexilatbehandling, og/eller til neutralisering af en overdosis af dabigatran eller dabigatranetexilat.
10. Fremgangsmåde til fremstilling af et antistofmolekyle ifølge et hvilket som helst af de foregående krav, hvilken fremgangsmåde omfatter (a) at tilvejebringe en værtscelle omfattende en eller flere nukleinsyrer kodende for antistofmolekylet i funktionel tilknytning til en udtrykkelsesstyringssekvens, (b) at dyrke værtscellen, og (c) at indvinde antistofmolekylet fra cellekulturen.
11. Sæt omfattende: (a) et antistof ifølge et hvilket som helst af kravene 1 til 7 eller en farmaceutisk sammensætning deraf; (b) farmaceutisk sammensætning af dabigatran, dabigatranetexilat, et profarmakon til dabigatran eller et farmaceutisk acceptabelt salt deraf; (c) en beholder, og (d) et mærke.
12. Sæt ifølge krav 11, hvor det farmaceutisk acceptable salt af dabigatranetexilat er et mesylatsalt.
13. Sæt ifølge krav 11 eller 12, hvor indholdet per doseringsenhed af dabigatran, da-bigatranetexilat, et profarmakon til dabigatran eller et farmaceutisk acceptabelt salt deraf er mellem 75 mg og 300 mg, enten én gang om dagen (QD) eller to gange om dagen (BID).
14. Sæt omfattende: (a) en første farmaceutisk sammensætning omfattende dabigatran, dabigatranetexi-lat, et profarmakon til dabigatran eller et farmaceutisk acceptabelt salt deraf; (b) en anden farmaceutisk sammensætning omfattende et antistof ifølge et hvilket som helst af kravene 1 til 7; (c) vejledning i særskilt indgift af den første og den anden farmaceutiske sammensætning til en patient, hvor den første og den anden farmaceutiske sammensætning er indeholdt i særskilte beholdere, og den anden farmaceutiske sammensætning er til anvendelse til indgift til en patient, som kræver neutralisering eller delvis neutralisering af dabigatran eller dabigatran-1-O-acylglucuronid.
15. Antistof ifølge et hvilket som helst af kravene 1 til 7 til anvendelse i en fremgangsmåde til neutralisering eller delvis neutralisering af dabigatran eller dabigatran-l-O-acylglu-curonid hos en patient, der behandles med dabigatran, dabigatranetexilat, et profarmakon til dabigatran eller et farmaceutisk acceptabelt salt deraf.
16. Antistof ifølge et hvilket som helst af kravene 1 til 7 til anvendelse i en fremgangsmåde til neutralisering eller delvis neutralisering af dabigatran eller dabigatran-l-O-acylglu-curonid hos en patient, omfattende: (a) at fastslå, at en patient er blevet behandlet med dabigatran, dabigatranetexilat, et profarmakon til dabigatran eller et farmaceutsik acceptabelt salt deraf, samt mængden, der er blevet indtaget af patienten; (b) at neutralisere dabigatran eller 1-O-acylglucuronid med et antistof ifølge et hvilket som helst af kravene 1 til 9, før der foretages en størknings- eller koaguleringstest eller -analyse, hvor dabigatran eller dabigatran-l-O-acylglucuronid ville interferere med en nøjagtig visning af test- eller analyseresultaterne; (c) at udføre størknings- eller koaguleringstesten eller -analysen på en prøve taget fra patienten for at bestemme graden af koageldannelse uden tilstedeværelse af dabigatran eller dabigatran-l-O-acylgucuronid; og (d) at indstille en mængde af dabigatran, dabigatranetexilat, et profarmakon til dabigatran eller et farmaceutisk acceptabelt salt deraf, som indgives til patienten, for at opnå en passende balance mellem koageldannelse og -nedbrydning hos en patient.
17. Antistof til anvendelse ifølge krav 15 eller 16, hvor mængden af antistof i forhold til dabigatran eller dabigatran-l-O-acylglucuronid ligger på et molforhold mellem 0,1 og 100.
18. Antistof til anvendelse ifølge krav 17, hvor mængden af antistof i forhold til dabigatran eller l-O-acylglucuronid-dabigatran ligger på et molforhold mellem 0,1 og 10.
19. Antistof til anvendelse ifølge krav 16, hvor den nøjagtige visning af test- eller analyseresultaterne er en nøjagtig visning af fibrinogenindhold, aktiveret protein C-resi-stens, eller lignende undersøgelser.
20. Farmaceutisk sammensætning omfattende antistoffet ifølge et hvilket som helst af kravene 1 til 7, samt et farmaceutisk acceptabelt bærestof.
DK11703410.8T 2010-01-20 2011-01-20 Middel mod antikoagulant. DK2525812T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP10151239 2010-01-20
US38391410P 2010-09-17 2010-09-17
PCT/EP2011/050749 WO2011089183A2 (en) 2010-01-20 2011-01-20 Anticoagulant antidotes

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DK2525812T3 true DK2525812T3 (da) 2017-02-27

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EP (2) EP3195876A1 (da)
JP (2) JP5575923B2 (da)
KR (1) KR101781787B1 (da)
CN (1) CN102711813B (da)
AP (1) AP2012006242A0 (da)
AR (1) AR079944A1 (da)
AU (1) AU2011208719C1 (da)
BR (1) BR112012018021B1 (da)
CA (1) CA2787566A1 (da)
CO (1) CO6571889A2 (da)
CY (2) CY1118875T1 (da)
DK (1) DK2525812T3 (da)
EA (1) EA028371B1 (da)
EC (1) ECSP12012105A (da)
ES (1) ES2614992T3 (da)
FR (1) FR17C1026I2 (da)
GE (1) GEP20156341B (da)
HK (1) HK1173957A1 (da)
HR (1) HRP20170613T1 (da)
HU (2) HUE032263T2 (da)
IL (1) IL219427B (da)
LT (2) LT2525812T (da)
LU (1) LUC00028I2 (da)
MA (1) MA33936B1 (da)
ME (1) ME02602B (da)
MX (1) MX2012008360A (da)
MY (1) MY162323A (da)
NL (1) NL300882I2 (da)
NO (2) NO2017034I1 (da)
NZ (1) NZ599508A (da)
PE (1) PE20121516A1 (da)
PL (1) PL2525812T3 (da)
PT (1) PT2525812T (da)
RS (1) RS55683B1 (da)
SG (1) SG182552A1 (da)
SI (1) SI2525812T1 (da)
TN (1) TN2012000366A1 (da)
TW (1) TWI513466B (da)
UA (1) UA110470C2 (da)
UY (1) UY33196A (da)
WO (1) WO2011089183A2 (da)
ZA (1) ZA201202876B (da)

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