AU2019243283C1 - Methods of treating ulcerative colitis - Google Patents

Methods of treating ulcerative colitis Download PDF

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Publication number
AU2019243283C1
AU2019243283C1 AU2019243283A AU2019243283A AU2019243283C1 AU 2019243283 C1 AU2019243283 C1 AU 2019243283C1 AU 2019243283 A AU2019243283 A AU 2019243283A AU 2019243283 A AU2019243283 A AU 2019243283A AU 2019243283 C1 AU2019243283 C1 AU 2019243283C1
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AU
Australia
Prior art keywords
administered
dose
mirikizumab
week
induction
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Active
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AU2019243283A
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English (en)
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AU2019243283A1 (en
AU2019243283B2 (en
Inventor
James Benedict CANAVAN
Stuart William FRIEDRICH
Kathryn Ann KRUEGER
Catherine MILCH
Jay Lawrence TUTTLE
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Eli Lilly and Co
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Eli Lilly and Co
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Publication of AU2019243283A1 publication Critical patent/AU2019243283A1/en
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Publication of AU2019243283B2 publication Critical patent/AU2019243283B2/en
Priority to AU2023248103A priority Critical patent/AU2023248103B2/en
Publication of AU2019243283C1 publication Critical patent/AU2019243283C1/en
Priority to AU2026203410A priority patent/AU2026203410A1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • 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
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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
    • C07K2317/70—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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
AU2019243283A 2018-03-30 2019-03-28 Methods of treating ulcerative colitis Active AU2019243283C1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2023248103A AU2023248103B2 (en) 2018-03-30 2023-10-11 Methods of treating ulcerative colitis
AU2026203410A AU2026203410A1 (en) 2018-03-30 2026-05-05 Methods of treating ulcerative colitis

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862650314P 2018-03-30 2018-03-30
US62/650,314 2018-03-30
PCT/US2019/024633 WO2019191464A1 (en) 2018-03-30 2019-03-28 Methods of treating ulcerative colitis

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2023248103A Division AU2023248103B2 (en) 2018-03-30 2023-10-11 Methods of treating ulcerative colitis

Publications (3)

Publication Number Publication Date
AU2019243283A1 AU2019243283A1 (en) 2020-09-24
AU2019243283B2 AU2019243283B2 (en) 2023-07-27
AU2019243283C1 true AU2019243283C1 (en) 2024-05-02

Family

ID=66429483

Family Applications (3)

Application Number Title Priority Date Filing Date
AU2019243283A Active AU2019243283C1 (en) 2018-03-30 2019-03-28 Methods of treating ulcerative colitis
AU2023248103A Active AU2023248103B2 (en) 2018-03-30 2023-10-11 Methods of treating ulcerative colitis
AU2026203410A Pending AU2026203410A1 (en) 2018-03-30 2026-05-05 Methods of treating ulcerative colitis

Family Applications After (2)

Application Number Title Priority Date Filing Date
AU2023248103A Active AU2023248103B2 (en) 2018-03-30 2023-10-11 Methods of treating ulcerative colitis
AU2026203410A Pending AU2026203410A1 (en) 2018-03-30 2026-05-05 Methods of treating ulcerative colitis

Country Status (29)

Country Link
US (2) US12152072B2 (cg-RX-API-DMAC10.html)
EP (3) EP4752157A2 (cg-RX-API-DMAC10.html)
JP (4) JP7119114B2 (cg-RX-API-DMAC10.html)
KR (1) KR102552693B1 (cg-RX-API-DMAC10.html)
CN (1) CN111936165A (cg-RX-API-DMAC10.html)
AU (3) AU2019243283C1 (cg-RX-API-DMAC10.html)
BR (1) BR112020018099A2 (cg-RX-API-DMAC10.html)
CA (1) CA3095297A1 (cg-RX-API-DMAC10.html)
DK (2) DK3773715T3 (cg-RX-API-DMAC10.html)
EA (1) EA202091989A1 (cg-RX-API-DMAC10.html)
ES (2) ES3063700T3 (cg-RX-API-DMAC10.html)
FI (2) FI4327866T3 (cg-RX-API-DMAC10.html)
HR (2) HRP20240904T1 (cg-RX-API-DMAC10.html)
HU (1) HUE067445T2 (cg-RX-API-DMAC10.html)
IL (2) IL312807B2 (cg-RX-API-DMAC10.html)
LT (2) LT3773715T (cg-RX-API-DMAC10.html)
MA (2) MA52216B1 (cg-RX-API-DMAC10.html)
MD (2) MD3773715T2 (cg-RX-API-DMAC10.html)
MX (1) MX2020010269A (cg-RX-API-DMAC10.html)
MY (1) MY202368A (cg-RX-API-DMAC10.html)
PL (2) PL4327866T3 (cg-RX-API-DMAC10.html)
PT (2) PT3773715T (cg-RX-API-DMAC10.html)
RS (2) RS65661B1 (cg-RX-API-DMAC10.html)
SG (1) SG11202009526RA (cg-RX-API-DMAC10.html)
SI (2) SI4327866T1 (cg-RX-API-DMAC10.html)
TW (2) TWI744617B (cg-RX-API-DMAC10.html)
UA (1) UA128578C2 (cg-RX-API-DMAC10.html)
WO (1) WO2019191464A1 (cg-RX-API-DMAC10.html)
ZA (1) ZA202005388B (cg-RX-API-DMAC10.html)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3972690A4 (en) 2019-05-23 2023-07-05 Janssen Biotech, Inc. METHOD OF TREATMENT OF INFLAMMATORY BOWEL DISEASE USING COMBINATION THERAPY OF ANTIBODIES TO IL-23 AND TNF-ALPHA
IL295545A (en) * 2020-02-14 2022-10-01 Janssen Biotech Inc Safe and effective method of treating ulcerative colitis with anti-il-12/il23 antibody
CA3183927A1 (en) 2020-05-21 2021-11-25 Janssen Biotech, Inc. Method of treating inflammatory bowel disease with a combination therapy of antibodies to il-23 and tnf alpha
JP7423815B2 (ja) * 2020-10-20 2024-01-29 セトラスホールディングス株式会社 治験管理装置、治験管理方法、治験管理プログラム及び治験管理システム
US20220259301A1 (en) * 2021-01-06 2022-08-18 Abbvie Inc. Methods of treating crohn's disease and ulcerative colitis
BR112023024064A2 (pt) * 2021-05-20 2024-01-30 Janssen Biotech Inc Método de tratamento de doença inflamatória intestinal com uma terapia de combinação de anticorpos para il-23 e tnf-alfa
WO2022251623A1 (en) * 2021-05-28 2022-12-01 Eli Lilly And Company Anti-il-23p19 antibody regulation of genes involved in ulcerative colitis
KR20240103043A (ko) * 2021-11-23 2024-07-03 얀센 바이오테크 인코포레이티드 항-il23 특이적 항체로 궤양성 결장염을 치료하는 방법
AU2023383916A1 (en) * 2022-11-22 2025-07-10 Janssen Biotech, Inc. Method of treating ulcerative colitis with anti-il23 specific antibody
JP7863690B2 (ja) 2023-03-10 2026-05-21 イーライ リリー アンド カンパニー 潰瘍性大腸炎を治療する方法
JP2026521705A (ja) * 2023-06-16 2026-07-01 イノベント バイオロジクス(スーチョウ)カンパニー,リミティド 炎症性腸疾患の治療における組換え抗インターロイキン23p19サブユニット抗体の使用
AU2025218720A1 (en) 2024-02-06 2026-05-21 Paragon Therapeutics, Inc. Il-23 antibody compositions and methods of use
WO2025171006A1 (en) 2024-02-06 2025-08-14 Paragon Therapeutics, Inc. Il-23 binding protein compositions and methods of use
WO2026060205A1 (en) 2024-09-13 2026-03-19 Eli Lilly And Company PAN-ELR+ CXC CHEMOKINE ANTIBODIES AND IL-23p19 ANTIBODIES FOR THE TREATMENT OF ULCERATIVE COLITIS

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070009526A1 (en) * 2005-06-30 2007-01-11 Jacqueline Benson Anti-IL-23 antibodies, compositions, methods and uses
WO2010062663A1 (en) * 2008-11-03 2010-06-03 Schering Corporation Inflammatory bowel disease biomarkers and related methods of treatment
US20120282269A1 (en) * 2010-11-04 2012-11-08 Boehringer Ingelheim International Gmbh Anti-IL-23 Antibodies
US20170002060A1 (en) * 2014-01-08 2017-01-05 Moderna Therapeutics, Inc. Polynucleotides for the in vivo production of antibodies

Family Cites Families (5)

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Publication number Priority date Publication date Assignee Title
SI3219328T1 (sl) 2005-12-29 2020-10-30 Janssen Biotech, Inc. Človeška protitelesa proti-IL-23, sestavki, postopki in uporabe
HUE042172T2 (hu) 2007-02-23 2019-06-28 Merck Sharp & Dohme Genetikailag elõállított anti-il-23P19 antitestek
JO3244B1 (ar) 2009-10-26 2018-03-08 Amgen Inc بروتينات ربط مستضادات il – 23 البشرية
JOP20140049B1 (ar) 2013-03-08 2021-08-17 Lilly Co Eli أجسام مضادة ترتبط بـ il-23
JP7516250B2 (ja) * 2018-03-05 2024-07-16 ヤンセン バイオテツク,インコーポレーテツド 抗il-23特異的抗体を用いたクローン病の治療方法

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070009526A1 (en) * 2005-06-30 2007-01-11 Jacqueline Benson Anti-IL-23 antibodies, compositions, methods and uses
WO2010062663A1 (en) * 2008-11-03 2010-06-03 Schering Corporation Inflammatory bowel disease biomarkers and related methods of treatment
US20120282269A1 (en) * 2010-11-04 2012-11-08 Boehringer Ingelheim International Gmbh Anti-IL-23 Antibodies
US20170002060A1 (en) * 2014-01-08 2017-01-05 Moderna Therapeutics, Inc. Polynucleotides for the in vivo production of antibodies

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
Allocca, M. et al., 'Evolving strategies and goals of treatment in ulcerative colitis', Best Practice & Research Clinical Gastroenterology', (2018-02-01), pages 1-2, DOI: 10.1016/j.bpg.2018.07.001 *
Clinical Trial NCT02589665: A Study of Mirikizumab (LY3074828) In Participants With Moderate to Severe Ulcerative Colitis, Version 49 (2018-01-19). *

Also Published As

Publication number Publication date
SG11202009526RA (en) 2020-10-29
JP2023166388A (ja) 2023-11-21
PL4327866T3 (pl) 2026-04-20
MD3773715T2 (ro) 2024-10-31
JP7331219B2 (ja) 2023-08-22
MA52216A (fr) 2021-02-17
TW202206104A (zh) 2022-02-16
IL312807B2 (en) 2025-06-01
IL277514B1 (en) 2024-07-01
NZ767902A (en) 2024-05-31
SI3773715T1 (sl) 2024-06-28
TWI837532B (zh) 2024-04-01
RS67806B1 (sr) 2026-03-31
JP2022169562A (ja) 2022-11-09
CA3095297A1 (en) 2019-10-03
EA202091989A1 (ru) 2021-01-13
DK3773715T3 (da) 2024-05-27
AU2023248103B2 (en) 2026-02-05
JP7571225B2 (ja) 2024-10-22
KR102552693B1 (ko) 2023-07-07
FI3773715T3 (fi) 2024-05-30
MX2020010269A (es) 2020-11-06
JP2021517156A (ja) 2021-07-15
UA128578C2 (uk) 2024-08-21
KR20200128101A (ko) 2020-11-11
IL277514A (en) 2020-11-30
LT4327866T (lt) 2026-03-10
MY202368A (en) 2024-04-24
AU2019243283A1 (en) 2020-09-24
MD4327866T2 (ro) 2026-04-30
IL312807A (en) 2024-07-01
US12152072B2 (en) 2024-11-26
PT3773715T (pt) 2024-05-27
AU2023248103A1 (en) 2023-11-09
DK4327866T3 (da) 2026-02-23
PL3773715T3 (pl) 2024-08-19
EP4327866B1 (en) 2025-12-10
EP3773715A1 (en) 2021-02-17
PT4327866T (pt) 2026-02-17
IL312807B1 (en) 2025-02-01
LT3773715T (lt) 2024-06-25
ES2983809T3 (es) 2024-10-24
EP4327866A2 (en) 2024-02-28
MA67901B1 (fr) 2026-02-27
EP3773715B1 (en) 2024-05-08
TWI744617B (zh) 2021-11-01
BR112020018099A2 (pt) 2020-12-22
WO2019191464A1 (en) 2019-10-03
HRP20260275T1 (hr) 2026-04-10
JP7119114B2 (ja) 2022-08-16
ZA202005388B (en) 2025-05-28
JP2025020134A (ja) 2025-02-12
AU2019243283B2 (en) 2023-07-27
IL277514B2 (en) 2024-11-01
HUE067445T2 (hu) 2024-10-28
RS65661B1 (sr) 2024-07-31
AU2026203410A1 (en) 2026-05-21
HRP20240904T1 (hr) 2024-10-11
MA52216B1 (fr) 2024-07-31
ES3063700T3 (en) 2026-04-20
FI4327866T3 (fi) 2026-02-18
US20250034243A1 (en) 2025-01-30
CN111936165A (zh) 2020-11-13
EP4752157A2 (en) 2026-06-03
US20210032325A1 (en) 2021-02-04
TW201946657A (zh) 2019-12-16
EP4327866A3 (en) 2024-03-20
SI4327866T1 (sl) 2026-04-30

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DA2 Applications for amendment section 104

Free format text: THE NATURE OF THE AMENDMENT IS AS SHOWN IN THE STATEMENT(S) FILED 11 OCT 2023

DA3 Amendments made section 104

Free format text: THE NATURE OF THE AMENDMENT IS AS SHOWN IN THE STATEMENT(S) FILED 11 OCT 2023

FGA Letters patent sealed or granted (standard patent)