DK1951279T3 - Compstatin og analoger deraf til øjensygdomme - Google Patents

Compstatin og analoger deraf til øjensygdomme Download PDF

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Publication number
DK1951279T3
DK1951279T3 DK06825651.0T DK06825651T DK1951279T3 DK 1951279 T3 DK1951279 T3 DK 1951279T3 DK 06825651 T DK06825651 T DK 06825651T DK 1951279 T3 DK1951279 T3 DK 1951279T3
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compstatin
composition
analog
eye
trp
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DK06825651.0T
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Cedric Francois
Pascal Deschatelets
Paul Olson
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Apellis Pharmaceuticals Inc
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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
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K9/0048—Eye, e.g. artificial tears
    • 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
    • A61K9/0048—Eye, e.g. artificial tears
    • A61K9/0051—Ocular inserts, ocular implants
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/06—Antiglaucoma agents or miotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • 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
    • C07K14/46—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • C07K14/47—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • 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
    • C07K14/78—Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin or cold insoluble globulin [CIG]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
    • C07K7/04—Linear peptides containing only normal peptide links
    • C07K7/08—Linear peptides containing only normal peptide links having 12 to 20 amino acids
    • 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
    • G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
    • G01N33/5008—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics
    • G01N33/5082—Supracellular entities, e.g. tissue, organisms
    • G01N33/5088—Supracellular entities, e.g. tissue, organisms of vertebrates
    • 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
    • C07K2319/00—Fusion polypeptide
    • C07K2319/01—Fusion polypeptide containing a localisation/targetting motif

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Animal Behavior & Ethology (AREA)
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  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Ophthalmology & Optometry (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biochemistry (AREA)
  • Urology & Nephrology (AREA)
  • Toxicology (AREA)
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  • Genetics & Genomics (AREA)
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  • Diabetes (AREA)
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Claims (15)

1. Sammensætning omfattende en effektiv mængde af en compstatinanalog til anvendelse ved behandling af en øjensygdom karakteriseret ved makulade-generation, choroidal neovaskularisation eller en kombination af disse i et individ med risiko for eller lidende af øjenforstyrreisen, hvor compstatinanaiogen er en forbindelse der omfatter et cyklisk peptid med en sekvens: Xaa1 - Gys - Val - Xaa2 - Gin - Asp - Xaa2* - Gly - Xaa3 - His - Arg - Gys -Xaa4 (SEG ID NO: 6); hvor: Xaa1 er ile, Val, Leu, B1-lle, B1-Vai, B1-Leu eller et dipeptid omfattende Gly-lle eller B1 - Gly -Ile, og B1 repræsenterer en første blokningsgruppe; Xaa2 er 1-methyltryptofan, Xaa2* er Trp eller analoger af Trp; Xaa3 er His, Ala eller en analog af Ala, Rhe, Trp eller en analog af Trp; Xaa4 er L-Thr, D-Thr, Ile, Val, Gly, et dipeptid udvalgt blandt Thr-Ala og Thr-Asn, eller et tripeptid omfattende Thr-Ala-Asn, hvor en carboxyterminal -OH af en hvilken som helst af L-Thr, D-Thr, Ile, Val, Gly, Åla, eller Åsn eventuelt er erstattet af en anden blokningsgruppe B2; og de to Gys-rester er forbundet med en disuifidbinding, hvor analogerne af Trp er udvalgt blandt aminosyrer omfattende to eller flere substituerede eller ikke-substituerede aromatiske ringe.
2. Sammensætning til anvendelse ifølge krav 1, hvor peptidet er acetyleret ved N-terminalen og/eller amideret ved G-termimaien.
3. Sammensætning til anvendelse ifølge krav 1, hvor compstatinanaiogen er en forbindelse, der omfatter et cyklisk peptid som har en sekvens af SEQ ID NO 28 eller 32.
4. Sammensætning til anvendelse ifølge krav 1, hvor sammensætningen er tilvejebragt til administration intravenøst, intravitrealt, intravitreait ved en oku-lær indføring, intravitrealt ved en okuiær indføring i en mængde mellem 100 og 500 pg eller intravitrealt i en formulering med langvarig frigørelses i en mængde mellem 100 og 10.000 pg eller intravitrealt i en formulering med langvarig frigørelse omfattende en pluralitet af mikropartikler eller nanopartik-ler kollektivt omfattende mellem 100 og 10.000 pg af compstatinanaiogen.
5. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1 til 3, hvor sammensætningen er tilvejebragt til lokal administration til øjet eller i nærheden af øjet.
6. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1 til 3 hvor sammensætningen er tilvejebragt til lokal administration som en væske eller hvor sammensætningen er tilvejebragt til lokal administration som en opløsning der danner en gel efter indføring i iegemet og hvor opløsningen er administreret ved en fremgangsmåde udvalgt fra gruppen bestående af retro-bulbær injektion, peribuibær injektion, subTenon injektion, subkonjunktival injektion og intravitreai injektion.
7. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1 til 3, hvor sammensætningen er tilvejebragt til lokal administration i nærheden af det bageste segment af øjet.
8. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1 til 7, hvor individet er blevet identificeret som bærende af en eller flere genetiske poiymorfier som øger risikoen før aldersrelaferet makuladegeneration eller hvor det yderligere bestemmes om individet har en genetisk polymoriisme der øger risikoen for aldersrelateret makuladegeneration.
9. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1 til 8, hvor en effektiv mængde af en angiogeneseinhibitor er administreret op til 4 uger før administrering af compstatinanalogen.
10. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1 til 3, hvor sammensætningen er i form af et okuiært implantat, en mikropartikei eller nanopartikei,
11. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1 til 10, hvor makuladegenerationen er aldersrelateret makuladegeneration.
12. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1 til 11, til anvendelse til inhibering af koroidal neovaskularisering i øjet.
13. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1 til 12, hvor sammensætningen inkluderer et opløseligt geldannende materiale.
14. Sammensætning til anvendelse ifølge krav 13, hvor det opløselige geldannende materiale er opløseligt kollagen, eller hvor det opløselige geldannende materiale er opløseligt kollagen og sammensætningen ydereligere omfatter fibriliære kollagen faste stoffer.
15. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1 til 14, omfattende en pluralitet af compstatinanaloggrupper som defineret i krav 1 kovalent eller ikke-kovalent bundet til en polymer rygrad eller skelet.
DK06825651.0T 2005-10-08 2006-10-06 Compstatin og analoger deraf til øjensygdomme DK1951279T3 (da)

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US72548405P 2005-10-08 2005-10-08
US72644705P 2005-10-12 2005-10-12
US76097406P 2006-01-19 2006-01-19
PCT/US2006/039397 WO2007044668A2 (en) 2005-10-08 2006-10-06 Compstatin and analogs thereof for eye disorders

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EP (2) EP1951279B1 (da)
JP (4) JP5345849B2 (da)
CN (3) CN105582523B (da)
AU (1) AU2006302212B2 (da)
BR (1) BRPI0617186A2 (da)
CA (1) CA2625206C (da)
DK (1) DK1951279T3 (da)
IL (1) IL190695A (da)
MX (1) MX351152B (da)
PL (1) PL1951279T3 (da)
WO (1) WO2007044668A2 (da)

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