DK3290046T3 - C1-inh-sammensætninger og fremgangsmåder til forebyggelsen og behandling af sygdomme associeret med c1-esteraseinhibitormangel - Google Patents
C1-inh-sammensætninger og fremgangsmåder til forebyggelsen og behandling af sygdomme associeret med c1-esteraseinhibitormangel Download PDFInfo
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- DK3290046T3 DK3290046T3 DK17177676.8T DK17177676T DK3290046T3 DK 3290046 T3 DK3290046 T3 DK 3290046T3 DK 17177676 T DK17177676 T DK 17177676T DK 3290046 T3 DK3290046 T3 DK 3290046T3
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- esterase inhibitor
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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
- A61K38/55—Protease inhibitors
- A61K38/57—Protease inhibitors from animals; from humans
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/14—Blood; Artificial blood
- A61K35/16—Blood plasma; Blood serum
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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
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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
- A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
- A61K38/1709—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
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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
- A61K38/55—Protease inhibitors
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- 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
- A61K47/02—Inorganic compounds
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- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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- 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
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- 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
- 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
- A61K9/0021—Intradermal administration, e.g. through microneedle arrays or needleless injectors
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- 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
- A61K9/08—Solutions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/81—Protease inhibitors
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Immunology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Marine Sciences & Fisheries (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Cell Biology (AREA)
- Hematology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Developmental Biology & Embryology (AREA)
- Virology (AREA)
- Biomedical Technology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Biotechnology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Peptides Or Proteins (AREA)
Claims (13)
1. Sammensætning omfattende mindst én Cl-esteraseinhibitor hvor den mindst ene Cl-esteraseinhibitor er til stede ved 400U/ml eller derover til anvendelse i behandling, inhibering, eller forebyggelse af arvelig angioødem (HAE) og hvor sammensætningen administreres subkutant, hvor sammensætningen omfatter phosphat.
2. Sammensætning til anvendelse ifølge krav 1, hvor sammensætningen omfatter natriumphosphatbuffer, eventuelt hvor sammensætningen omfatter 5 mM til 50 mM natriumphosphat, 10 mM til 30 mM natriumphosphat, eller 20 mM natriumphosphat.
3. Sammensætning til anvendelse ifølge krav 1 eller krav 2, hvor den mindst ene Cl-esteraseinhibitor er til stede ved op til 500 U/ml.
4. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1-3, hvor den mindst ene Cl-esteraseinhibitor administreres ved et dosisområde fra 500 enheder til 5000 enheder, 1000 enheder til 3500 enheder, eller 1500 enheder til 2500 enheder.
5. Sammensætning til anvendelse ifølge et hvilket som helst af de foregående krav, hvor den mindst ene Cl-esteraseinhibitor administreres dagligt, hver anden dag, hver 3 dag, én gang om ugen, to gange om ugen eller tre gange om ugen.
6. Sammensætning til anvendelse ifølge et hvilket som helst af de foregående krav, hvor individet administreres med en høj indledende dosis af den mindst ene Cl-esteraseinhibitor, efterfulgt af lavere vedligeholdelsesdoser, eventuelt hvor den høje indledende dosis er mindst 1,5, 2, 3, 4, eller 5 gange de efterfølgende doser, og/eller den høje indledende dosis administreres intravenøst og den mindst ene Cl-esteraseinhibitor administreres efterfølgende subkutant.
7. Sammensætning til anvendelse ifølge et hvilket som helst af de foregående krav, hvor administrationen af den mindst ene Cl-esteraseinhibitor fører til øgede niveauer af Cl-esteraseinhibitoren i individets blod, hvor blodniveauerne af Cl-esteraseinhibitoren er steget til mindst 0,3 U/ml, 0,4 U/ml, eller op til 1 U/ml.
8. Sammensætning til anvendelse ifølge et hvilket som helst af de foregående krav, hvor blodniveauerne af Cl-esteraseinhibitoren opretholdes ved eller over 0,4 U/ml for mindst 50%, mindst 75%, mindst 90%, eller mindst 95% af tiden.
9. Sammensætning til anvendelse ifølge et hvilket som helst af de foregående krav, hvor: (i) det arvelige angioødem er Type I eller Type II HAE, (ii) administrationen af den mindst éne Cl-esteraseinhibitor resulterer i HAE profylaktisk behandling, (iii) behandlingen af HAE resulterer i mindst en reduktion i sværhedsgraden og/eller antallet af HAE-attack, eller (iv) administrationen af den mindst ene Cl-esteraseinhibitor resulterer i behandling af et HAE-attack.
10. Sammensætning til anvendelse ifølge et hvilket som helst af de foregående krav, hvor den mindst ene Cl-esteraseinhibitor isoleres eller oprenses fra humant plasma eller er fremstillet rekombinant, og/eller hvor Cl-esteraseinhibitoren har en aminosyresekvens der er mindst 90%, 95%, 98%, 99% eller 100% identisk med den humane Cl-esteraseinhibitoraminosyre-sekvens af figur 1.
11. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1-10, omfattende en buffer hvor bufferen ikke indeholder citrat eller citronsyre.
12. Sammensætning til anvendelse ifølge et hvilket som helst af de foregående krav, hvor sammensætningen: (i) omfatter mindst én aminosyre eller salt deraf; og/eller (ii) har en pH på mellem 6,5 og 8,0.
13. Sammensætning til anvendelse ifølge et hvilket som helst af de foregående krav hvor sammensætning er dannet fra en lyofiliseret form ved rekonstitution i en buffer før administration.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361791399P | 2013-03-15 | 2013-03-15 | |
| EP14762343.3A EP2968434B1 (en) | 2013-03-15 | 2014-03-17 | C1-inh compositions for use in the prevention and treatment of hereditary angioedema (hae). |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK3290046T3 true DK3290046T3 (da) | 2019-03-18 |
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Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK17177676.8T DK3290046T3 (da) | 2013-03-15 | 2014-03-17 | C1-inh-sammensætninger og fremgangsmåder til forebyggelsen og behandling af sygdomme associeret med c1-esteraseinhibitormangel |
| DK14762343.3T DK2968434T3 (da) | 2013-03-15 | 2014-03-17 | C1-INH-sammensætninger til anvendelse til forebyggelse og behandling af arvelig angioødem (HAE). |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK14762343.3T DK2968434T3 (da) | 2013-03-15 | 2014-03-17 | C1-INH-sammensætninger til anvendelse til forebyggelse og behandling af arvelig angioødem (HAE). |
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| US (9) | US9616111B2 (da) |
| EP (3) | EP3508213A1 (da) |
| JP (9) | JP6184581B2 (da) |
| KR (4) | KR20150135242A (da) |
| CN (2) | CN105517559A (da) |
| AU (3) | AU2014232912A1 (da) |
| BR (1) | BR112015023207A8 (da) |
| CA (2) | CA3054718A1 (da) |
| CY (2) | CY1119419T1 (da) |
| DE (1) | DE202014011208U1 (da) |
| DK (2) | DK3290046T3 (da) |
| EA (1) | EA201591278A1 (da) |
| ES (2) | ES2713004T3 (da) |
| GB (1) | GB2530921B (da) |
| HK (1) | HK1250912B (da) |
| HR (2) | HRP20171269T1 (da) |
| HU (2) | HUE041837T2 (da) |
| IL (2) | IL241549B (da) |
| LT (2) | LT3290046T (da) |
| ME (2) | ME03326B (da) |
| MX (3) | MX389449B (da) |
| PL (2) | PL3290046T3 (da) |
| PT (2) | PT3290046T (da) |
| RS (2) | RS58351B1 (da) |
| SG (2) | SG11201507616VA (da) |
| SI (2) | SI3290046T1 (da) |
| SM (2) | SMT201700415T1 (da) |
| TR (1) | TR201900319T4 (da) |
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| RS58351B1 (sr) | 2013-03-15 | 2019-03-29 | Shire Viropharma Inc | C1-inh kompozicije i postupci za prevenciju i lečenje poremećaja koji su povezani sa deficijencijom inhibitora c1 esteraze |
| EP4162947A1 (en) | 2013-11-22 | 2023-04-12 | Takeda Pharmaceutical Company Limited | Methods of treating antibody-mediated rejection in organ transplant patients with c1-esterase inhibitor |
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| US20190183991A1 (en) * | 2016-08-23 | 2019-06-20 | Csl Behring Gmbh | Method of preventing acute attacks of hereditary angioedema associated with c1 esterase inhibitor deficiency |
| CN110769848A (zh) * | 2017-05-16 | 2020-02-07 | 瑞士奥克特珐玛公司 | C1-酯酶抑制剂制剂 |
| WO2019166572A1 (en) | 2018-02-28 | 2019-09-06 | Pharming Intellectual Property B.V. | Pharmaceutical system for transdermal administration of a c1 -esterase inhibitor |
| CA3092163A1 (en) | 2018-02-28 | 2019-09-06 | Pharming Intellectual Property B.V. | Treatment and prevention of pre-eclampsia |
| JP7788711B2 (ja) | 2018-06-22 | 2025-12-19 | 株式会社Junten Bio | 複合状態を有する細胞混合物を用いた、免疫寛容を誘導する抗体、及び誘導されたリンパ球、また誘導されたリンパ球を用いる細胞治療剤及び治療法 |
| US12139537B2 (en) | 2018-06-22 | 2024-11-12 | Junten Bio Co., Ltd. | Antibody inducing immune tolerance, induced lymphocyte, and cell therapy agent therapeutic method using induced lymphocyte |
| US12234287B2 (en) | 2018-06-22 | 2025-02-25 | Junten Bio Co., Ltd. | Method for eliciting infectious immunological tolerance |
| WO2021124793A1 (ja) * | 2019-12-16 | 2021-06-24 | ニプロ株式会社 | 凝集防止剤ならびにそれを用いた医薬組成物および医療用デバイス |
| EP3895726A1 (en) | 2020-04-17 | 2021-10-20 | Pharming Intellectual Property BV | Using c1 esterase inhibitor to treat viral infection-related acute respiratory distress |
| CN117120076A (zh) * | 2021-01-27 | 2023-11-24 | 斯帕克治疗公司 | 用于治疗遗传性血管性水肿的组合物和方法 |
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| KR20230046146A (ko) | 2021-09-29 | 2023-04-05 | 주식회사 엘지에너지솔루션 | 배터리 제어 시스템 및 방법 |
| WO2025090843A1 (en) * | 2023-10-27 | 2025-05-01 | Kansas State University Research Foundation | Small-molecule inhibitors of c1s protease and classical complement pathway |
| CN119823254B (zh) * | 2025-03-14 | 2025-06-03 | 深圳市卫光生物制品股份有限公司 | 一种c1酯酶抑制剂重组变体及其制备方法和应用 |
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