JP2022513098A - 体重減少及び／又は食物摂取量低減に使用するためのｇｄｆ１５類似体及び方法 - Google Patents

体重減少及び／又は食物摂取量低減に使用するためのｇｄｆ１５類似体及び方法 Download PDF

Info

Publication number
JP2022513098A
JP2022513098A JP2021527918A JP2021527918A JP2022513098A JP 2022513098 A JP2022513098 A JP 2022513098A JP 2021527918 A JP2021527918 A JP 2021527918A JP 2021527918 A JP2021527918 A JP 2021527918A JP 2022513098 A JP2022513098 A JP 2022513098A
Authority
JP
Japan
Prior art keywords
dose
administered
fusion protein
study
subject
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
JP2021527918A
Other languages
English (en)
Japanese (ja)
Other versions
JP2022513098A5 (enExample
Inventor
ジャン，ソンマオ
キムコ，ホリー
ヘルマン，ロバート
ファブリニ，エリサ
ストヤノビッチ－ススリック，ヴェドラナ
ローゼンバーグ，ポール
Original Assignee
ヤンセン ファーマシューティカ エヌ．ベー．
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by ヤンセン ファーマシューティカ エヌ．ベー． filed Critical ヤンセン ファーマシューティカ エヌ．ベー．
Publication of JP2022513098A publication Critical patent/JP2022513098A/ja
Publication of JP2022513098A5 publication Critical patent/JP2022513098A5/ja
Priority to JP2025019347A priority Critical patent/JP2025081388A/ja
Withdrawn legal-status Critical Current

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/475—Growth factors; Growth regulators
    • C07K14/495—Transforming growth factor [TGF]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18—Growth factors; Growth regulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/64—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/643—Albumins, e.g. HSA, BSA, ovalbumin or a Keyhole Limpet Hemocyanin [KHL]
    • 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
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/76—Albumins
    • C07K14/765—Serum albumin, e.g. HSA
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/20—Fusion polypeptide containing a tag with affinity for a non-protein ligand
    • C07K2319/21—Fusion polypeptide containing a tag with affinity for a non-protein ligand containing a His-tag
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/31—Fusion polypeptide fusions, other than Fc, for prolonged plasma life, e.g. albumin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Epidemiology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Toxicology (AREA)
  • Immunology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
JP2021527918A 2018-11-20 2019-11-19 体重減少及び／又は食物摂取量低減に使用するためのｇｄｆ１５類似体及び方法 Withdrawn JP2022513098A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025019347A JP2025081388A (ja) 2018-11-20 2025-02-07 体重減少及び／又は食物摂取量低減に使用するためのｇｄｆ１５類似体及び方法

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862769675P 2018-11-20 2018-11-20
US62/769,675 2018-11-20
PCT/IB2019/059945 WO2020104948A1 (en) 2018-11-20 2019-11-19 Gdf15 analogs and methods for use in decreasing body weight and/or reducing food intake

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2025019347A Division JP2025081388A (ja) 2018-11-20 2025-02-07 体重減少及び／又は食物摂取量低減に使用するためのｇｄｆ１５類似体及び方法

Publications (2)

Publication Number Publication Date
JP2022513098A true JP2022513098A (ja) 2022-02-07
JP2022513098A5 JP2022513098A5 (enExample) 2022-11-25

Family

ID=70773869

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2021527918A Withdrawn JP2022513098A (ja) 2018-11-20 2019-11-19 体重減少及び／又は食物摂取量低減に使用するためのｇｄｆ１５類似体及び方法
JP2025019347A Pending JP2025081388A (ja) 2018-11-20 2025-02-07 体重減少及び／又は食物摂取量低減に使用するためのｇｄｆ１５類似体及び方法

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2025019347A Pending JP2025081388A (ja) 2018-11-20 2025-02-07 体重減少及び／又は食物摂取量低減に使用するためのｇｄｆ１５類似体及び方法

Country Status (15)

Country Link
US (2) US20220315633A1 (enExample)
EP (1) EP3883960A4 (enExample)
JP (2) JP2022513098A (enExample)
KR (1) KR20210094584A (enExample)
CN (2) CN113474363A (enExample)
AU (2) AU2019383019A1 (enExample)
BR (1) BR112021009225A2 (enExample)
CA (1) CA3120236A1 (enExample)
EA (1) EA202191424A1 (enExample)
IL (1) IL283189A (enExample)
JO (1) JOP20210111A1 (enExample)
MX (1) MX2021005908A (enExample)
PH (1) PH12021551119A1 (enExample)
SG (1) SG11202104952PA (enExample)
WO (1) WO2020104948A1 (enExample)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MY205905A (en) 2018-10-22 2024-11-20 Janssen Pharmaceutica Nv Glucagon like peptide 1 (glp1)-growth differentiation factor 15 (gdf15) fusion proteins and uses thereof
ES3061099T3 (en) 2019-10-04 2026-03-31 Amgen Inc Use of gdf15 for treating cardiometabolic syndrome and other conditions
IL310535A (en) * 2021-08-10 2024-03-01 Byomass Inc Anti-gdf15 antibodies, compositions and uses thereof
WO2023154953A1 (en) 2022-02-14 2023-08-17 Ngm Biopharmaceuticals, Inc. Gdf15 polypeptides for treating and preventing autoimmune diseases

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017196647A1 (en) * 2016-05-10 2017-11-16 Janssen Biotech, Inc. Gdf15 fusion proteins and uses thereof

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9131966B2 (en) * 2013-03-11 2015-09-15 DePuy Synthes Products, Inc. Vertebral manipulation assembly
EP3157947A1 (en) * 2014-06-23 2017-04-26 Novartis AG Hsa-gdf-15 fusion polypeptide and use thereof
US20190000923A1 (en) * 2015-12-22 2019-01-03 Novartis Ag Methods of treating or ameliorating metabolic disorders using growth differentiation factor 15 (gdf-15)
MY205905A (en) * 2018-10-22 2024-11-20 Janssen Pharmaceutica Nv Glucagon like peptide 1 (glp1)-growth differentiation factor 15 (gdf15) fusion proteins and uses thereof

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017196647A1 (en) * 2016-05-10 2017-11-16 Janssen Biotech, Inc. Gdf15 fusion proteins and uses thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
XIONG, Y. ET AL.: "Long-acting MIC-1/GDF15 molecules to treat obesity: Evidence from mice to monkeys", SCIENCE TRANSLATIONAL MEDICINE, vol. 9, no. 412, JPN6023053167, 2017, pages 8732, ISSN: 0005227562 *

Also Published As

Publication number Publication date
EP3883960A1 (en) 2021-09-29
MX2021005908A (es) 2021-09-08
EA202191424A1 (ru) 2021-08-24
JP2025081388A (ja) 2025-05-27
AU2019383019A1 (en) 2021-06-03
US20260159562A1 (en) 2026-06-11
PH12021551119A1 (en) 2021-11-22
US20220315633A1 (en) 2022-10-06
AU2025202337A1 (en) 2025-04-24
JOP20210111A1 (ar) 2021-05-19
KR20210094584A (ko) 2021-07-29
EP3883960A4 (en) 2022-11-09
CN113474363A (zh) 2021-10-01
WO2020104948A1 (en) 2020-05-28
IL283189A (en) 2021-06-30
SG11202104952PA (en) 2021-06-29
CA3120236A1 (en) 2020-05-28
BR112021009225A2 (pt) 2021-10-05
CN121818901A (zh) 2026-04-10

Similar Documents

Publication Publication Date Title
TW201201832A (en) Pharmaceutical composition comprising AVE0010 and insulin glargine
JP5269945B2 (ja) インスリングラルギンの長時間作用型製剤
JP2025081388A (ja) 体重減少及び／又は食物摂取量低減に使用するためのｇｄｆ１５類似体及び方法
US20220323550A1 (en) Pegloticase for treatment of gout in renal transplant recipients
ES2895513T3 (es) Tratamiento con lixisenatida de pacientes pediátricos con diabetes mellitus tipo 2
KR20170094361A (ko) 인슐린 글라진／릭시세나티드 고정비 제형
JP5197012B2 (ja) 大腸連続性を伴う短腸症候群患者の治療
US20260070997A1 (en) Cd40l-specific tn3-derived scaffolds for the treatment and prevention of sjögren's syndrome
US20260098087A1 (en) Dosages of emactuzumab
CA2868688A1 (en) Compositions, methods and assays comprising amylin or amlyin analogs for abeta-peptide mediated disorders
TWI865759B (zh) 涉及過量游離light之方法及治療
EA051453B1 (ru) Способы лечения и профилактики рассеянного склероза с применением соединений замещенного аминопиримидина
Harris CLINICAL PROTOCOL APPROVAL FORM
Korth-Bradley et al. Core Entrustable Professional Activities in Clinical Pharmacology for Entering Residency: Biologics
NZ734595B2 (en) Treatment of pediatric type 2 diabetes mellitus patients with lixisenatide
BR112017015099B1 (pt) Uso de lixisenatida e/ou um sal farmaceuticamente aceitável da mesma para tratar pacientes pediátricos portadores de diabetes mellitus tipo 2

Legal Events

Date Code Title Description
A711 Notification of change in applicant

Free format text: JAPANESE INTERMEDIATE CODE: A711

Effective date: 20211227

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20221116

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20221116

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20231226

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20240325

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20240626

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20241008

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20250207

A761 Written withdrawal of application

Free format text: JAPANESE INTERMEDIATE CODE: A761

Effective date: 20250312