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HRP20230182T1 - Modulatori aktivnosti komplementa - Google Patents

Modulatori aktivnosti komplementa Download PDF

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Publication number
HRP20230182T1
HRP20230182T1 HRP20230182TT HRP20230182T HRP20230182T1 HR P20230182 T1 HRP20230182 T1 HR P20230182T1 HR P20230182T T HRP20230182T T HR P20230182TT HR P20230182 T HRP20230182 T HR P20230182T HR P20230182 T1 HRP20230182 T1 HR P20230182T1
Authority
HR
Croatia
Prior art keywords
pharmaceutical preparation
polypeptide
concentration
preparation according
administered
Prior art date
Application number
HRP20230182TT
Other languages
English (en)
Inventor
Steven James DEMARCO
Michelle Denise HOARTY
Grace Victoria PARKER
Alonso RICARDO
Sylvia TOBE
Douglas A. Treco
Original Assignee
Ra Pharmaceuticals, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ra Pharmaceuticals, Inc. filed Critical Ra Pharmaceuticals, Inc.
Publication of HRP20230182T1 publication Critical patent/HRP20230182T1/hr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/10Peptides having 12 to 20 amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/30Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Diabetes (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Oscillators With Electromechanical Resonators (AREA)
  • Steroid Compounds (AREA)
  • Amplifiers (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Claims (14)

1. Vodeni farmaceutski pripravak koji sadrži polipeptid inhibitora C5 koji ima jezgru sekvence SEQ ID NO: 1; sol; i pufersko sredstvo.
2. Farmaceutski pripravak prema zahtjevu 1, naznačen time što sol sadrži natrijev klorid.
3. Farmaceutski pripravak prema zahtjevu 1 ili 2, naznačen time što pufersko sredstvo sadrži natrijev fosfat.
4. Farmaceutski pripravak prema zahtjevu 2 ili 3, naznačen time što farmaceutski pripravak sadrži natrijev klorid u koncentraciji od 25 mM do 100 mM.
5. Farmaceutski pripravak prema zahtjevu 3 ili 4, naznačen time što farmaceutski pripravak sadrži natrijev fosfat u koncentraciji od 10 mM do 100 mM.
6. Farmaceutski pripravak prema bilo kojem od zahtjeva 1-5: (a) pri čemu je polipeptid prisutan u koncentraciji od 1 mg/mL do 400 mg/mL; (b) koji sadrži pH od 6,5 do 7,5; (c) pri čemu se polipeptid veže na C5 s ravnotežnom konstantom disocijacije (KD) od 0,1 nM do 1 nM; (d) pri čemu polipeptid blokira proizvodnju C5a nakon aktivacije alternativnog puta aktivacije komplementa; ili (e) pri čemu polipeptid blokira formiranje kompleksa napada membrane (MAC) nakon aktivacije klasičnog puta, alternativnog puta ili lektinskog puta aktivacije komplementa.
7. Farmaceutski pripravak prema zahtjevu 6, naznačen time što je polipeptid prisutan u koncentraciji od 40 mg/mL.
8. Farmaceutski pripravak prema zahtjevu 6 ili 7, naznačen time što farmaceutski pripravak sadrži 75,7 mM natrijevog klorida i 50 mM natrijevog fosfata, te pH pripravka iznosi 6,7-7,3.
9. Farmaceutski pripravak prema bilo kojem od zahtjeva 1-8, naznačen time što je za upotrebu kao lijek.
10. Farmaceutski pripravak za upotrebu prema zahtjevu 9, naznačen time što se farmaceutski pripravak primjenjuje potkožno (SC) ili intravenski (IV).
11. Farmaceutski pripravak za upotrebu prema zahtjevu 9 ili 10, naznačen time što subjekt nije koloniziran s Neisseria meningitides.
12. Farmaceutski pripravak za upotrebu prema bilo kojem od zahtjeva 9-11, naznačen time što se subjektu istovremeno daje jedan ili više antibiotika kako bi se smanjio rizik od infekcije s Neisseria meningitides, pri čemu, izborno, jedan ili više antibiotika sadrži ciprofloksacin, pri čemu se, izborno, ciprofloksacin oralno primjenjuje u dozi od oko 100 mg do oko 1000 mg.
13. Farmaceutski pripravak za upotrebu prema bilo kojem od zahtjeva 9-12, naznačen time što se farmaceutski pripravak primjenjuje u kombinaciji s ekulizumabom.
14. Auto-injektorski uređaj, naznačen time što sadrži farmaceutski pripravak prema bilo kojem od zahtjeva 1-8.
HRP20230182TT 2015-12-16 2016-12-07 Modulatori aktivnosti komplementa HRP20230182T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201562268360P 2015-12-16 2015-12-16
US201662331320P 2016-05-03 2016-05-03
US201662347486P 2016-06-08 2016-06-08
EP20157916.6A EP3685847B1 (en) 2015-12-16 2016-12-07 Modulators of complement activity

Publications (1)

Publication Number Publication Date
HRP20230182T1 true HRP20230182T1 (hr) 2023-04-14

Family

ID=57758701

Family Applications (2)

Application Number Title Priority Date Filing Date
HRP20230182TT HRP20230182T1 (hr) 2015-12-16 2016-12-07 Modulatori aktivnosti komplementa
HRP20200508TT HRP20200508T1 (hr) 2015-12-16 2020-03-27 Modulatori aktivnosti i komplementa

Family Applications After (1)

Application Number Title Priority Date Filing Date
HRP20200508TT HRP20200508T1 (hr) 2015-12-16 2020-03-27 Modulatori aktivnosti i komplementa

Country Status (25)

Country Link
US (2) US10835574B2 (hr)
EP (3) EP3685847B1 (hr)
JP (3) JP7126940B2 (hr)
KR (1) KR20180094913A (hr)
CN (2) CN115920000A (hr)
AU (1) AU2016370210A1 (hr)
BR (1) BR112018012174A2 (hr)
CA (1) CA3007772A1 (hr)
CY (1) CY1123031T1 (hr)
DK (2) DK3685847T5 (hr)
ES (2) ES2781551T3 (hr)
FI (1) FI3685847T3 (hr)
HR (2) HRP20230182T1 (hr)
HU (1) HUE061759T2 (hr)
IL (1) IL259762B (hr)
LT (2) LT3685847T (hr)
MX (2) MX2018007352A (hr)
PL (2) PL3389692T3 (hr)
PT (2) PT3389692T (hr)
RS (2) RS64067B1 (hr)
RU (2) RU2769701C2 (hr)
SG (1) SG11201804721SA (hr)
SI (2) SI3389692T1 (hr)
TW (2) TWI745320B (hr)
WO (1) WO2017105939A1 (hr)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RS62428B1 (sr) 2014-06-12 2021-11-30 Ra Pharmaceuticals Inc Modulacija aktivnosti komplementa
LT3250230T (lt) 2015-01-28 2021-12-27 Ra Pharmaceuticals, Inc. Komplemento aktyvumo moduliatoriai
EP3685847B1 (en) 2015-12-16 2023-01-11 RA Pharmaceuticals, Inc. Modulators of complement activity
MX2019006527A (es) 2016-12-07 2019-08-01 Ra Pharmaceuticals Inc Moduladores de la actividad del complemento.
EP3720463A1 (en) 2017-12-04 2020-10-14 RA Pharmaceuticals, Inc. Modulators of complement activity
US20220160820A1 (en) 2019-03-08 2022-05-26 Ra Pharmaceuticals, Inc. Modulators of complement activity
CA3137895A1 (en) 2019-04-24 2020-10-29 Ra Pharmaceuticals, Inc. Compositions and methods for modulating complement activity
ES2973767T3 (es) 2019-06-04 2024-06-24 Ra Pharmaceuticals Inc Tratamiento de enfermedades inflamatorias con inhibidores del complemento
BR112022002522A2 (pt) 2019-09-12 2022-08-16 Ra Pharmaceuticals Inc Tratamento de doenças neurológicas com inibidores do complemento
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