HRP20231015T1 - Upotreba antagonista il-13 u liječenju atopičnog dermatitisa - Google Patents

Upotreba antagonista il-13 u liječenju atopičnog dermatitisa Download PDF

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HRP20231015T1
HRP20231015T1 HRP20231015TT HRP20231015T HRP20231015T1 HR P20231015 T1 HRP20231015 T1 HR P20231015T1 HR P20231015T T HRP20231015T T HR P20231015TT HR P20231015 T HRP20231015 T HR P20231015T HR P20231015 T1 HRP20231015 T1 HR P20231015T1
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dose
lebrikizumab
antibody against
monoclonal antibody
atopic dermatitis
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HRP20231015TT
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ChinYu LIN
Theodore A. OMACHI
Ryan P. OWEN
Karl YEN
Yanan Zheng
Kendra DEBUSK
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F. Hoffmann-La Roche Ag
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    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244Interleukins [IL]
    • AHUMAN NECESSITIES
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    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
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    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
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    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K39/00Medicinal preparations containing antigens or antibodies
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • C07K2317/00Immunoglobulins specific features
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    • C07ORGANIC CHEMISTRY
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    • C07K2317/00Immunoglobulins specific features
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding

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Claims (15)

1. Monoklonsko protutijelo protiv IL-13, namijenjeno upotrebi u liječenju atopičnog dermatitisa kod pacijenta, naznačeno time što treba primijeniti najmanje jednu udarnu dozu, a najmanje jednu naknadnu dozu održavanja treba primijeniti supkutano, u ravnoj dozi, gdje je protutijelo protiv IL-13 lebrikizumab, te gdje (a) udarna doza je 250 mg, a doza održavanja je 125 mg, ili (b) udarna doza je 500 mg, a doza održavanja je 250 mg.
2. Monoklonsko protutijelo protiv IL-13, namijenjeno upotrebi u skladu s patentnim zahtjevom 1, naznačeno time što je udarna doza 250 mg, a doza održavanja je 125 mg.
3. Monoklonsko protutijelo protiv IL-13, namijenjeno upotrebi u skladu s patentnim zahtjevom 1, naznačeno time što je udarna doza 500 mg, a doza održavanja je 250 mg.
4. Monoklonsko protutijelo protiv IL-13, namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačeno time što dozu održavanja treba primijeniti četiri tjedna nakon udarne doze, te što dozu održavanja treba primijeniti jednom svaka četiri tjedna nakon toga za vrijeme trajanja liječenja.
5. Monoklonsko protutijelo protiv IL-13, namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačeno time što je trajanje liječenja 24 tjedna ili više.
6. Monoklonsko protutijelo protiv IL-13, namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačeno time što lebrikizumab smanjuje težinu bolesti kod pacijenta, te što težinu bolesti treba procijeniti iz mjere ishoda težine bolesti atopičnog dermatitisa.
7. Monoklonsko protutijelo protiv IL-13, namijenjeno upotrebi u skladu s patentnim zahtjevom 6, naznačeno time što je mjera ishoda težine bolesti atopičnog dermatitisa indeks površine i težina egzema (EASI), te što lebrikizumab smanjuje EASI za 50% ili 75% ili 90% u usporedbi s EASI kojeg treba odrediti prije primjene prve doze lebrikizumaba; gdje se EASI može odrediti 12 tjedana nakon primjene prve doze ili 20 tjedana nakon primjene prve doze ili 24 tjedna nakon primjene prve doze lebrikizumaba.
8. Monoklonsko protutijelo protiv IL-13, namijenjeno upotrebi u skladu s patentnim zahtjevom 6, naznačeno time što je mjera ishoda težine bolesti atopičnog dermatitisa ocjenjivanje težine atopičnog dermatitisa (SCORAD), te što lebrikizumab smanjuje SCORAD za 50% ili 75% u usporedbi sa SCORAD kojeg treba odrediti prije primjene prve doze lebrikizumaba; gdje se SCORAD može odrediti 12 tjedana nakon primjene prve doze lebrikizumaba.
9. Monoklonsko protutijelo protiv IL-13, namijenjeno upotrebi u skladu s patentnim zahtjevom 6, naznačeno time što je mjera ishoda težine bolesti atopičnog dermatitisa ispitivačeva globalna procjena (IGA), te što lebrikizumab smanjuje IGA na nulu ili jedan; gdje se IGA može odrediti 12 tjedana nakon primjene prve doze lebrikizumaba.
10. Monoklonsko protutijelo protiv IL-13, namijenjeno upotrebi u skladu s patentnim zahtjevom 6, naznačeno time što je mjera ishoda težine bolesti atopičnog dermatitisa ishod kojeg prijavljuje pacijent (PRO), gdje je PRO (1) vizualna analogna skala svrbež (VAS), gdje lebrikizumab smanjuje svrbež VAS za 40% do 55%, (2) VAS gubitka sna, gdje lebrikizumab smanjuje VAS gubitka sna za 53% do 61%, ili (3) ocjena iz upitnika o utjecaju atopičnog dermatitisa (ADIQ), gdje lebrikizumab smanjuje ocjenu iz ADIQ za 54% do 65%; gdje se PRO može odrediti 12 tjedana nakon primjene prve doze lebrikizumaba.
11. Monoklonsko protutijelo protiv IL-13, namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 10, naznačeno time što lebrikizumab treba primijeniti na pacijentu uz pomoć uređaja za supkutanu primjenu, gdje se uređaj za supkutanu primjenu bira između prethodno napunjene štrcaljke, jednokratnom injekcijskom olovkom, uređaja s mikroiglom, mikroinfuzijskog uređaja, injekcijskog uređaja bez igle ili autoinjektora.
12. Monoklonsko protutijelo protiv IL-13, namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 11, naznačeno time što na pacijentu treba primijeniti jedan ili više topikalnih kortikosteroida.
13. Monoklonsko protutijelo protiv IL-13, namijenjeno upotrebi u skladu s patentnim zahtjevom 12, naznačeno time što se jedan ili više topikalnih kortikosteroida bira između triamcinolon-acetonida, hidrokortizona, ili kombinacije triamcinolon-acetonida i hidrokortizona.
14. Monoklonsko protutijelo protiv IL-13, namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 13, naznačeno time što je pacijent star 12 godina i više, i/ili što je pacijent neadekvatno kontroliran na topikalne kortikosteroide.
15. Monoklonsko protutijelo protiv IL-13, namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 14, naznačeno time što je atopični dermatitis umjeren do težak, što se utvrđuje iz ocjene prema Rajka/Langelandovim kriterijima, te što je određeno da je ocjena prema Rajka/Langelandovim kriterijima između 4,5 i 9.
HRP20231015TT 2016-09-23 2017-09-22 Upotreba antagonista il-13 u liječenju atopičnog dermatitisa HRP20231015T1 (hr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US201662398713P 2016-09-23 2016-09-23
US201762527204P 2017-06-30 2017-06-30
US201762530683P 2017-07-10 2017-07-10
US201762539037P 2017-07-31 2017-07-31
EP17780280.8A EP3528838B1 (en) 2016-09-23 2017-09-22 Uses of il-13 antagonists for treating atopic dermatitis
PCT/US2017/052891 WO2018057849A1 (en) 2016-09-23 2017-09-22 Uses of il-13 antagonists for treating atopic dermatitis

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US (2) US11434286B2 (hr)
EP (2) EP3528838B1 (hr)
JP (1) JP6995844B2 (hr)
KR (1) KR102557643B1 (hr)
CN (1) CN109715201A (hr)
AU (1) AU2017330405B2 (hr)
CA (1) CA3031589A1 (hr)
DK (1) DK3528838T3 (hr)
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FI (2) FI3528838T3 (hr)
HR (1) HRP20231015T1 (hr)
HU (1) HUE063135T2 (hr)
IL (1) IL265473B2 (hr)
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MX (1) MX2019002672A (hr)
NL (1) NL301269I2 (hr)
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RS (1) RS64550B1 (hr)
RU (1) RU2752785C2 (hr)
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