HRP20230385T1 - Kombinirana terapija sa cnp agonistima s kontroliranim oslobađanjem - Google Patents
Kombinirana terapija sa cnp agonistima s kontroliranim oslobađanjem Download PDFInfo
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- HRP20230385T1 HRP20230385T1 HRP20230385TT HRP20230385T HRP20230385T1 HR P20230385 T1 HRP20230385 T1 HR P20230385T1 HR P20230385T T HRP20230385T T HR P20230385TT HR P20230385 T HRP20230385 T HR P20230385T HR P20230385 T1 HRP20230385 T1 HR P20230385T1
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- 239000000556 agonist Substances 0.000 title claims 18
- 238000013270 controlled release Methods 0.000 title claims 16
- 238000002648 combination therapy Methods 0.000 title 1
- 239000003814 drug Substances 0.000 claims 23
- 229940079593 drug Drugs 0.000 claims 20
- 239000000825 pharmaceutical preparation Substances 0.000 claims 18
- 206010008723 Chondrodystrophy Diseases 0.000 claims 8
- 206010058314 Dysplasia Diseases 0.000 claims 6
- 208000008919 achondroplasia Diseases 0.000 claims 6
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 6
- 208000035475 disorder Diseases 0.000 claims 6
- 230000000638 stimulation Effects 0.000 claims 6
- 208000011580 syndromic disease Diseases 0.000 claims 6
- 206010010356 Congenital anomaly Diseases 0.000 claims 5
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims 4
- 102000002265 Human Growth Hormone Human genes 0.000 claims 4
- 108010000521 Human Growth Hormone Proteins 0.000 claims 4
- 239000000854 Human Growth Hormone Substances 0.000 claims 4
- 206010031243 Osteogenesis imperfecta Diseases 0.000 claims 4
- 231100000518 lethal Toxicity 0.000 claims 4
- 230000001665 lethal effect Effects 0.000 claims 4
- 239000008194 pharmaceutical composition Substances 0.000 claims 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 4
- FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 claims 2
- 206010013883 Dwarfism Diseases 0.000 claims 2
- 102000018997 Growth Hormone Human genes 0.000 claims 2
- 108010051696 Growth Hormone Proteins 0.000 claims 2
- 206010049933 Hypophosphatasia Diseases 0.000 claims 2
- 208000001182 Kniest dysplasia Diseases 0.000 claims 2
- 206010024503 Limb reduction defect Diseases 0.000 claims 2
- 208000037153 Mesomelic dysplasia, Nievergelt type Diseases 0.000 claims 2
- 208000011262 Micromelia Diseases 0.000 claims 2
- 206010028095 Mucopolysaccharidosis IV Diseases 0.000 claims 2
- 208000004286 Osteochondrodysplasias Diseases 0.000 claims 2
- 201000001718 Roberts syndrome Diseases 0.000 claims 2
- 208000005568 Robinow syndrome Diseases 0.000 claims 2
- 208000020221 Short stature Diseases 0.000 claims 2
- 208000005065 achondrogenesis Diseases 0.000 claims 2
- 201000007047 acrodysostosis Diseases 0.000 claims 2
- 208000001884 acromesomelic dysplasia Diseases 0.000 claims 2
- 230000001668 ameliorated effect Effects 0.000 claims 2
- 201000007845 atelosteogenesis Diseases 0.000 claims 2
- 230000015572 biosynthetic process Effects 0.000 claims 2
- 208000017568 chondrodysplasia Diseases 0.000 claims 2
- 208000001020 chondrodysplasia punctata Diseases 0.000 claims 2
- 150000001875 compounds Chemical class 0.000 claims 2
- 201000007394 diastrophic dysplasia Diseases 0.000 claims 2
- 208000003350 fibrochondrogenesis Diseases 0.000 claims 2
- 239000000122 growth hormone Substances 0.000 claims 2
- 201000010072 hypochondroplasia Diseases 0.000 claims 2
- 208000011426 mesomelic dysplasia Diseases 0.000 claims 2
- 201000010828 metaphyseal dysplasia Diseases 0.000 claims 2
- 208000010978 mucopolysaccharidosis type 4 Diseases 0.000 claims 2
- 229910052757 nitrogen Inorganic materials 0.000 claims 2
- 230000009984 peri-natal effect Effects 0.000 claims 2
- 208000027612 peripheral dysostosis Diseases 0.000 claims 2
- 230000004962 physiological condition Effects 0.000 claims 2
- 239000000651 prodrug Substances 0.000 claims 2
- 229940002612 prodrug Drugs 0.000 claims 2
- 230000002441 reversible effect Effects 0.000 claims 2
- 125000006850 spacer group Chemical group 0.000 claims 2
- 201000010809 spondyloepimetaphyseal dysplasia Diseases 0.000 claims 2
- 239000000126 substance Substances 0.000 claims 2
- 201000003896 thanatophoric dysplasia Diseases 0.000 claims 2
- 208000016264 Femoral agenesis/hypoplasia Diseases 0.000 claims 1
- 230000002265 prevention Effects 0.000 claims 1
- 210000001694 thigh bone Anatomy 0.000 claims 1
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
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- 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
- A61K38/22—Hormones
- A61K38/2242—Atrial natriuretic factor complex: Atriopeptins, atrial natriuretic protein [ANP]; Cardionatrin, Cardiodilatin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
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- 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
- A61K38/22—Hormones
- A61K38/27—Growth hormone [GH], i.e. somatotropin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- 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
- A61K47/56—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 an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
- A61K47/59—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 an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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Claims (35)
1. Kombinacija od CNP agonista s kontroliranim otpuštanjem, naznačena time, da CNP agonist s kontroliranim otpuštanjem oslobađa najmanje jedan CNP agonist pod fiziološkim uvjetima s vremenom oslobađanja poluživota od najmanje šest sati, pri čemu CNP agonist je CNP, te najmanje jedan daljnji biološki aktivni ostatak ili lijek za uporabu u postupku liječenja ili prevencije poremećaja koji se poboljšava stimulacijom rasta, pri čemu najmanje jedan daljnji biološki aktivni ostatak ili lijek je hormon rasta.
2. Kombinacija za uporabu prema patentnom zahtjevu 1, naznačena time, da CNP ima slijed SEQ ID NO: 2, 19, 20, 21, 22, 23, 24, 25, 26, 30, 32, 38, 39, 40, 41, 42, 43, 91 ili 92.
3. Kombinacija za uporabu prema patentnom zahtjevu 1 ili 2, naznačena time, da CNP ima slijed SEQ ID NO: 24.
4. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1 do 3, naznačena time, da najmanje jedan daljnji biološki aktivni ostatak ili lijek je ljudski hormon rasta.
5. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1 do 4, naznačena time, da najmanje jedan daljnji biološki aktivni ostatak ili lijek je ljudski hormon rasta koji ima slijed SEQ ID NO: 99.
6. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1 do 5, naznačena time, da najmanje jedan daljnji biološki aktivni ostatak ili lijek je lijek u svojem slobodnom obliku.
7. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1 do 5, naznačena time, da se najmanje jedan daljnji biološki aktivni ostatak ili lijek nalazi u obliku stabilnog konjugata.
8. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1 do 5, naznačena time, da najmanje jedan daljnji biološki aktivni ostatak ili lijek je spoj s kontroliranim otpuštanjem.
9. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1 do 5 ili 8, naznačena time, da najmanje jedan daljnji biološki aktivni ostatak ili lijek ima formulu (A1):
[image]
gdje n = 200 do 250.
10. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1 do 9, naznačena time, da su CNP i najmanje jedan daljnji biološki aktivni ostatak ili lijek formulirani za istovremenu, odvojenu ili redoslijednu primjenu.
11. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1 do 10, naznačena time, da su CNP i najmanje jedan daljnji biološki aktivni ostatak ili lijek formulirani u jednom farmaceutskom pripravku za istovremenu primjenu.
12. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1 do 11, naznačena time, da se poremećaj koji dobiva poboljšanje od stimulacije rasta, bira iz skupine koju čine ahondroplazija, hipohondroplazija, nizak rast, patuljasti rast, osteohondrodisplazija, tanatoforična displazija, osteogeneza imperfekta, ahondrogeneza, hondrodisplazija punktata, homozigotna ahondroplazija, kamptomelna displazija, kongenitalna smrtonosna hipofosfatazija, perinatalni smrtonosni tip osteogeneze imperfekta, polidaktilni sindromi kratkih rebara, rizomelijski tip hondrodisplazije punktata, Jansenov tip metafizealne displazije, spondiloepifizealna kongenitalna displazija, atelosteogeneza, dijastrofična displazija, kongenitalna kratka bedrena kost, Langerov tip mezomelijske displazije, Nievergeltov tip mezomelijske displazije, Robinowov sindrom, Reinhardtov sindrom, akrodizostoza, periferna dizostoza, Kniestova displazija, fibrohondrogeneza, Robertsov sindrom, akromezomelijska displazija, mikromelija, Morquioov sindrom, Kniestov sindrom, metatrofna displazija, i spondiloepimetafizealna displazija.
13. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1 do 12, naznačena time, da poremećaj koji se poboljšava stimulacijom rasta jest ahondroplazija.
14. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1 do 13, naznačena time, da je CNP agonist s kontroliranim otpuštanjem topiv u vodi.
15. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1 do 14, naznačena time, da CNP agonist s kontroliranim otpuštanjem ima formulu (Ia) ili (Ib):
[image]
[image]
gdje
-D je CNP ostatak;
-L1- je reverzibilni ostatak poveznika predlijeka;
-L2- je jednostruka kemijska veza ili ostatak držača razmaka;
-Z je ostatak nosača koji je topiv u vodi;
x je cijeli broj odabran iz skupine koju čine 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 i 16; i
y je cijeli broj odabran iz skupine koju čine 1, 2, 3, 4 i 5.
16. Kombinacija za uporabu prema patentnom zahtjevu 15, naznačena time, da CNP agonist s kontroliranim otpuštanjem ima formulu (IIf):
[image]
u kojoj
neoznačena crtkana linija pokazuje vezanje na dušik od -D koji je CNP ostatak sa slijedom SEQ ID NO: 24, putem tvorbe amidne veze; i
crtkana linija označena sa zvjezdicom pokazuje vezanje na -Z koji ima strukturu
[image]
gdje
svaki -Za je
[image]
pri čemu
svaki c1 je cijeli broj koji se neovisno nalazi u rasponu od 200 do 250.
17. Farmaceutski pripravak, naznačen time, da sadrži najmanje jedan CNP agonist s kontroliranim otpuštanjem, pri čemu CNP agonist s kontroliranim otpuštanjem oslobađa najmanje jedan CNP agonist, dok CNP agonist je CNP, pod fiziološkim uvjetima s vremenom oslobađanja poluživota od najmanje šest sati, gdje farmaceutski pripravak sadrži najmanje jedan daljnji biološki aktivni ostatak ili lijek, i pri čemu najmanje jedan daljnji biološki aktivni ostatak ili lijek je hormon rasta.
18. Farmaceutski pripravak prema patentnom zahtjevu 17, naznačen time, da CNP ima slijed SEQ ID NO: 2, 19, 20, 21, 22, 23, 24, 25, 26, 30, 32, 38, 39, 40, 41, 42, 43, 91 ili 92.
19. Farmaceutski pripravak prema patentnom zahtjevu 17 ili 18, naznačen time, da CNP ima slijed SEQ ID NO: 24.
20. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 17 do 19, naznačen time, da najmanje jedan daljnji biološki aktivni ostatak ili lijek je ljudski hormon rasta.
21. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 17 do 20, naznačen time, da najmanje jedan daljnji biološki aktivni ostatak ili lijek je ljudski hormon rasta koji ima slijed SEQ ID NO: 99.
22. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 17 do 21, naznačen time, da najmanje jedan daljnji biološki aktivni ostatak ili lijek je lijek u svojem slobodnom obliku.
23. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 17 do 21, naznačen time, da se najmanje jedan daljnji biološki aktivni ostatak ili lijek nalazi u obliku stabilnog konjugata.
24. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 17 do 21, naznačen time, da se najmanje jedan daljnji biološki aktivni ostatak ili lijek nalazi u obliku spoja s kontroliranim otpuštanjem.
25. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 17 do 21 ili 24, naznačen time, da najmanje jedan daljnji biološki aktivni ostatak ili lijek ima formulu (A1):
[image]
u kojoj n = 200 do 250.
26. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 17 do 25, naznačen time, da su CNP agonist s kontroliranim otpuštanjem i najmanje jedan daljnji biološki aktivni ostatak ili lijek formulirani za istovremenu, odvojenu ili redoslijednu primjenu.
27. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 17 do 26, naznačen time, da su CNP agonist s kontroliranim otpuštanjem i najmanje jedan daljnji biološki aktivni ostatak ili lijek formulirani u jednom farmaceutskom pripravku za istovremenu primjenu.
28. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 17 do 27, naznačen time, da CNP agonist s kontroliranim otpuštanjem nije topiv u vodi.
29. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 17 do 27, naznačen time, da je CNP agonist s kontroliranim otpuštanjem topiv u vodi.
30. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 17 do 27 ili 29, naznačen time, da CNP agonist s kontroliranim otpuštanjem ima formulu (Ia) ili (Ib):
[image]
[image]
gdje
-D je CNP ostatak;
-L1- je reverzibilni ostatak poveznika predlijeka;
-L2- je jednostruka kemijska veza ili ostatak držača razmaka;
-Z je ostatak nosača koji je topiv u vodi;
x je cijeli broj odabran iz skupine koju čine 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 i 16; i
y je cijeli broj odabran iz skupine koju čine 1, 2, 3, 4 i 5.
31. Farmaceutski pripravak prema patentnom zahtjevu 30, naznačen time, da CNP agonist s kontroliranim otpuštanjem ima formulu (IIf):
[image]
u kojoj
neoznačena crtkana linija pokazuje vezanje na dušik od -D koji je CNP ostatak sa slijedom SEQ ID NO: 24, putem tvorbe amidne veze; i
crtkana linija označena sa zvjezdicom pokazuje vezanje na -Z koji ima strukturu
[image]
pri čemu
svaki -Za je
[image]
gdje
svaki c1 se neovisno nalazi u rasponu od 200 do 250.
32. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 17 do 31, naznačen time, da je za uporabu kao lijek.
33. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 17 do 31, naznačen time, da je za uporabu u liječenju pacijenta koji boluje od poremećaja koji se poboljšava stimulacijom rasta.
34. Farmaceutski pripravak prema za uporabu prema patentnom zahtjevu 33, naznačen time, da se poremećaj koji dobiva poboljšanje od stimulacije rasta bira iz skupine koju čine ahondroplazija, hipohondroplazija, nizak rast, patuljasti rast, osteohondrodisplazija, tanatoforična displazija, osteogeneza imperfekta, ahondrogeneza, hondrodisplazija punktata, homozigotna ahondroplazija, kamptomelna displazija, kongenitalna smrtonosna hipofosfatazija, perinatalni smrtonosni tip osteogeneze imperfekta, polidaktilni sindromi kratkih rebara, rizomelijski tip hondrodisplazije punktata, Jansenov tip metafizealne displazije, spondiloepifizealna kongenitalna displazija, atelosteogeneza, dijastrofična displazija, kongenitalna kratka bedrena kost, Langerov tip mezomelijske displazije, Nievergeltov tip mezomelijske displazije, Robinowov sindrom, Reinhardtov sindrom, akrodizostoza, periferna dizostoza, Kniestova displazija, fibrohondrogeneza, Robertsov sindrom, akromezomelijska displazija, mikromelija, Morquioov sindrom, Kniestov sindrom, metatrofna displazija, i spondiloepimetafizealna displazija.
35. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 33 ili 34, naznačen time, da poremećaj koji se poboljšava stimulacijom rasta jest ahondroplazija.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP16191456 | 2016-09-29 | ||
PCT/EP2017/074596 WO2018060314A1 (en) | 2016-09-29 | 2017-09-28 | Combination therapy with controlled-release cnp agonists |
EP17781429.0A EP3518930B1 (en) | 2016-09-29 | 2017-09-28 | Combination therapy with controlled-release cnp agonists |
Publications (1)
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EP (2) | EP4223309A1 (hr) |
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AU (2) | AU2017336253B2 (hr) |
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CA (1) | CA3037448A1 (hr) |
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FI (1) | FI3518930T3 (hr) |
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HU (1) | HUE062117T2 (hr) |
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SI (1) | SI3518930T1 (hr) |
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