HRP20220737T1 - Upalni biomarkeri za predviđanje odgovaranja na spoj fgf-18 - Google Patents

Upalni biomarkeri za predviđanje odgovaranja na spoj fgf-18 Download PDF

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Publication number
HRP20220737T1
HRP20220737T1 HRP20220737TT HRP20220737T HRP20220737T1 HR P20220737 T1 HRP20220737 T1 HR P20220737T1 HR P20220737T T HRP20220737T T HR P20220737TT HR P20220737 T HRP20220737 T HR P20220737T HR P20220737 T1 HRP20220737 T1 HR P20220737T1
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Croatia
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fgf
compound
treatment
subject
sensitivity
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HRP20220737TT
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English (en)
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Christoph H. Ladel
Hans Guehring
Anne-Christine BAY-JENSEN
Morten Karsdal
Per Qvist
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Merck Patent Gmbh
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Publication of HRP20220737T1 publication Critical patent/HRP20220737T1/hr

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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6887Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids from muscle, cartilage or connective tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18Growth factors; Growth regulators
    • A61K38/1825Fibroblast growth factor [FGF]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/04Drugs for skeletal disorders for non-specific disorders of the connective tissue
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/10Musculoskeletal or connective tissue disorders
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/52Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
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  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
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  • Animal Behavior & Ethology (AREA)
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  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Biochemistry (AREA)
  • Cell Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Food Science & Technology (AREA)
  • Microbiology (AREA)
  • Physics & Mathematics (AREA)
  • Biotechnology (AREA)
  • Analytical Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Claims (8)

1. Postupak predviđanja osjetljivosti na liječenje sa spojem FGF-18 (faktor rasta fibroblasta 18) kod subjekta koji ima poremećaj hrskavice, naznačen time što postupak sadrži korake: a) određivanje, iz uzorka od navedenog subjekta, količine najmanje jednog od biomarkera odabranih iz grupe koja se sastoji od C1M (kolagen tipa I degradiran metaloproteinazom), C3M (kolagen tipa 3 degradiran metaloproteinazom) i/ili CRPM (C-reaktivni protein degradiran metaloproteinazom); i b) predviđanje na osnovu rezultata iz koraka a) dobre ili niske osjetljivosti navedenog subjekta na liječenje sa spojem FGF-18, pri čemu je spoj FGF-18 protein koji zadržava najmanje jednu biološku aktivnost humanog FGF-18 proteina.
2. Postupak u skladu sa patentnim zahtjevom 1, naznačen time što sadrži korake predviđanja niske osjetljivosti na liječenje sa spojem FGF-18 iz prisustva: a) C1M višeg od 30,0 ± 2SD ng/ml, i/ili b) C3M višeg od 12,0 ± 2SD ng/ml, i/ili c) CRPM višeg od 10,0 ± 2SD ng/ml.
3. Postupak u skladu sa patentnim zahtjevom 1, naznačen time što sadrži korake predviđanja dobre osjetljivosti, ili osjetljivosti, na liječenje sa spojem FGF-18 iz prisustva: a) C1M nižeg od 30,0 ± 2SD ng/ml, i/ili b) C3M nižeg od 12,0 ± 2SD ng/ml, i/ili c) CRPM nižeg od 10,0 ± 2SD ng/ml.
4. Postupak za odabir subjekta koji ima poremećaj hrskavice za uključivanje u ili isključivanje iz specifičnog doznog režima kada se navedeni subjekt treba liječiti sa spojem FGF-18, na osnovu vjerojatnosti njegove osjetljivosti na navedeno liječenje, naznačen time što sadrži korake: a) određivanje, iz uzorka od navedenog subjekta, količine najmanje jednog od biomarkera odabranih iz grupe koja se sastoji od C1M, C3M i/ili CRPM; pri čemu je količina najmanje jednog od ovih proteina predvidljiva za rizik subjekta da ima dobru osjetljivost (ili osjetljivost) ili nisku osjetljivost na navedeno liječenje, i b) odabir odgovarajućeg doznog režima u skladu sa rizikom subjekta da ima dobru osjetljivost ili nisku osjetljivost na navedeno liječenje, pri čemu je navedeni odgovarajući dozni režim najmanje dva ciklusa liječenja od 100 μg spoja FGF-18 koje se daje jednom tjedno tokom 3 uzastopna tjedna po ciklusu liječenja.
5. Postupak u skladu sa patentnim zahtjevom 4, naznačen time što sadrži korake isključivanja iz liječenja sa spojem FGF-18 subjekta koji prezentira: a) C1M viši od 30,0 ± 2SD ng/ml, i/ili b) C3M viši od 12,0 ± 2SD ng/ml, i/ili c) CRPM viši od 10,0 ± 2SD ng/ml, pri čemu se isključeno liječenje sa spojem FGF-18 sastoji od sljedećeg doznog režima: dva ciklusa liječenja od 100 μg spoja FGF-18 koje se daje jednom tjedno tokom 3 uzastopna tjedna po ciklusu liječenja.
6. Postupak u skladu sa patentnim zahtjevom 4, naznačen time što sadrži korake uključivanja u liječenje sa spojem FGF-18, bez obzira na dozni režim, subjekta koji prezentira: a) C1M niži od 30,0 ± 2SD ng/ml, i/ili b) C3M niži od 12,0 ± 2SD ng/ml, i/ili c) CRPM niži od 10,0 ± 2SD ng/ml.
7. Postupak u skladu sa bilo kojim od patentnih zahtjeva 1 do 6, naznačen time što je spoj FGF-18 sprifermin ili fuzioni protein koji sadrži FGF-18 funkcionalnu grupu.
8. Postupak u skladu sa bilo kojim od patentnih zahtjeva 1 do 7, naznačen time što je poremećaj hrskavice odabran iz grupe koja se sastoji od osteoartritisa, povrede hrskavice, prijeloma koji zahvaćaju zglobnu hrskavicu ili kirurških procedura sa utjecajem na zglobnu hrskavicu, kao što je mikrofraktura.
HRP20220737TT 2017-09-29 2018-09-28 Upalni biomarkeri za predviđanje odgovaranja na spoj fgf-18 HRP20220737T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP17194169 2017-09-29
EP18169317 2018-04-25
PCT/EP2018/076391 WO2019063756A1 (en) 2017-09-29 2018-09-28 INFLAMMATORY BIOMARKERS FOR PREDICTING REACTIVITY TO FGF-18 COMPOUND
EP18782012.1A EP3688468B1 (en) 2017-09-29 2018-09-28 Inflammatory biomarkers for predicting responsiveness to fgf-18 compound

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HRP20220737T1 true HRP20220737T1 (hr) 2022-09-02

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HRP20220737TT HRP20220737T1 (hr) 2017-09-29 2018-09-28 Upalni biomarkeri za predviđanje odgovaranja na spoj fgf-18

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US (2) US11467169B2 (hr)
EP (1) EP3688468B1 (hr)
JP (1) JP7418324B2 (hr)
CN (1) CN111164429A (hr)
AU (1) AU2018343980A1 (hr)
CA (1) CA3075713A1 (hr)
DK (1) DK3688468T3 (hr)
ES (1) ES2918249T3 (hr)
HR (1) HRP20220737T1 (hr)
HU (1) HUE058848T2 (hr)
IL (1) IL273574A (hr)
LT (1) LT3688468T (hr)
PL (1) PL3688468T3 (hr)
RS (1) RS63292B1 (hr)
SI (1) SI3688468T1 (hr)
WO (1) WO2019063756A1 (hr)

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HRP20220760T1 (hr) 2017-09-29 2022-09-02 Merck Patent Gmbh Metabolički biomarkeri za predviđanje odgovaranja na spoj fgf-18

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2264175B1 (en) 1996-10-16 2012-11-21 ZymoGenetics, Inc. Fibroblast growth factor homologs
JP4754823B2 (ja) 2002-10-07 2011-08-24 ザイモジェネティクス, インコーポレイテッド Fgf18の投与方法
CA2592261C (en) 2004-12-10 2015-11-24 Zymogenetics Inc. Fgf18 production in prokaryotic hosts
EP2054050B1 (en) 2006-08-25 2012-08-08 Ares Trading S.A. Treatment of cartilage disorders with fgf-18
US10221456B2 (en) 2012-08-06 2019-03-05 Merck Patent Gmbh Genetic markers for predicting responsiveness to FPG-18 compound
WO2015084883A2 (en) * 2013-12-02 2015-06-11 Abbvie, Inc. Compositions and methods for treating osteoarthritis
AR099510A1 (es) * 2014-02-20 2016-07-27 Merck Patent Gmbh Régimen de dosaje del compuesto fgf-18
HRP20220760T1 (hr) 2017-09-29 2022-09-02 Merck Patent Gmbh Metabolički biomarkeri za predviđanje odgovaranja na spoj fgf-18

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JP2020535423A (ja) 2020-12-03
DK3688468T3 (da) 2022-06-20
RS63292B1 (sr) 2022-06-30
HUE058848T2 (hu) 2022-09-28
US11467169B2 (en) 2022-10-11
SI3688468T1 (sl) 2022-08-31
WO2019063756A1 (en) 2019-04-04
PL3688468T3 (pl) 2022-07-18
EP3688468A1 (en) 2020-08-05
US20230258659A1 (en) 2023-08-17
JP7418324B2 (ja) 2024-01-19
LT3688468T (lt) 2022-06-27
IL273574A (en) 2020-05-31
ES2918249T3 (es) 2022-07-14
CA3075713A1 (en) 2019-04-04
CN111164429A (zh) 2020-05-15
EP3688468B1 (en) 2022-03-16
AU2018343980A1 (en) 2020-04-02
US20210231680A1 (en) 2021-07-29

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