HRP20220737T1 - Upalni biomarkeri za predviđanje odgovaranja na spoj fgf-18 - Google Patents
Upalni biomarkeri za predviđanje odgovaranja na spoj fgf-18 Download PDFInfo
- 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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- Prior art keywords
- fgf
- compound
- treatment
- subject
- sensitivity
- Prior art date
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- 102000003977 fibroblast growth factor 18 Human genes 0.000 title claims 17
- 108090000370 fibroblast growth factor 18 Proteins 0.000 title claims 17
- 150000001875 compounds Chemical class 0.000 title claims 13
- 239000000090 biomarker Substances 0.000 title claims 3
- 230000002757 inflammatory effect Effects 0.000 title 1
- 230000004043 responsiveness Effects 0.000 title 1
- 230000035945 sensitivity Effects 0.000 claims 11
- 238000000034 method Methods 0.000 claims 9
- 206010061762 Chondropathy Diseases 0.000 claims 3
- 102000005741 Metalloproteases Human genes 0.000 claims 3
- 108010006035 Metalloproteases Proteins 0.000 claims 3
- 208000015100 cartilage disease Diseases 0.000 claims 3
- 210000001188 articular cartilage Anatomy 0.000 claims 2
- 230000007717 exclusion Effects 0.000 claims 2
- 102000004169 proteins and genes Human genes 0.000 claims 2
- 108090000623 proteins and genes Proteins 0.000 claims 2
- 108010074051 C-Reactive Protein Proteins 0.000 claims 1
- 102100032752 C-reactive protein Human genes 0.000 claims 1
- 206010007710 Cartilage injury Diseases 0.000 claims 1
- 102000008186 Collagen Human genes 0.000 claims 1
- 108010035532 Collagen Proteins 0.000 claims 1
- 102000012422 Collagen Type I Human genes 0.000 claims 1
- 108010022452 Collagen Type I Proteins 0.000 claims 1
- 206010017076 Fracture Diseases 0.000 claims 1
- 208000013201 Stress fracture Diseases 0.000 claims 1
- 230000004071 biological effect Effects 0.000 claims 1
- 229920001436 collagen Polymers 0.000 claims 1
- 229940096422 collagen type i Drugs 0.000 claims 1
- 125000000524 functional group Chemical group 0.000 claims 1
- 108020001507 fusion proteins Proteins 0.000 claims 1
- 102000037865 fusion proteins Human genes 0.000 claims 1
- 201000008482 osteoarthritis Diseases 0.000 claims 1
- 229950002135 sprifermin Drugs 0.000 claims 1
- 238000001356 surgical procedure Methods 0.000 claims 1
- 230000003442 weekly effect Effects 0.000 claims 1
Classifications
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- 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
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6887—Chemical 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
-
- 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
- A61K38/1825—Fibroblast growth factor [FGF]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/04—Drugs for skeletal disorders for non-specific disorders of the connective tissue
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/10—Musculoskeletal or connective tissue disorders
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/52—Predicting 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)
- Biomedical Technology (AREA)
- 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)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Zoology (AREA)
- Epidemiology (AREA)
- 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.
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 |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20220737T1 true HRP20220737T1 (hr) | 2022-09-02 |
Family
ID=63722379
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20220737TT HRP20220737T1 (hr) | 2017-09-29 | 2018-09-28 | Upalni biomarkeri za predviđanje odgovaranja na spoj fgf-18 |
Country Status (16)
Country | Link |
---|---|
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) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
HRP20220760T1 (hr) | 2017-09-29 | 2022-09-02 | Merck Patent Gmbh | Metabolički biomarkeri za predviđanje odgovaranja na spoj fgf-18 |
Family Cites Families (8)
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 |
-
2018
- 2018-09-28 JP JP2020517797A patent/JP7418324B2/ja active Active
- 2018-09-28 DK DK18782012.1T patent/DK3688468T3/da active
- 2018-09-28 PL PL18782012.1T patent/PL3688468T3/pl unknown
- 2018-09-28 LT LTEPPCT/EP2018/076391T patent/LT3688468T/lt unknown
- 2018-09-28 EP EP18782012.1A patent/EP3688468B1/en active Active
- 2018-09-28 CA CA3075713A patent/CA3075713A1/en active Pending
- 2018-09-28 US US16/650,878 patent/US11467169B2/en active Active
- 2018-09-28 AU AU2018343980A patent/AU2018343980A1/en active Pending
- 2018-09-28 SI SI201830693T patent/SI3688468T1/sl unknown
- 2018-09-28 WO PCT/EP2018/076391 patent/WO2019063756A1/en unknown
- 2018-09-28 HR HRP20220737TT patent/HRP20220737T1/hr unknown
- 2018-09-28 ES ES18782012T patent/ES2918249T3/es active Active
- 2018-09-28 HU HUE18782012A patent/HUE058848T2/hu unknown
- 2018-09-28 CN CN201880063173.4A patent/CN111164429A/zh active Pending
- 2018-09-28 RS RS20220541A patent/RS63292B1/sr unknown
-
2020
- 2020-03-24 IL IL273574A patent/IL273574A/en unknown
-
2022
- 2022-09-01 US US17/929,261 patent/US20230258659A1/en active Pending
Also Published As
Publication number | Publication date |
---|---|
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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