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HRP20210694T1 - Pripravci koji sadrže actriia polipeptide za uporabu za liječenje plućne hipertenzije - Google Patents

Pripravci koji sadrže actriia polipeptide za uporabu za liječenje plućne hipertenzije Download PDF

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Publication number
HRP20210694T1
HRP20210694T1 HRP20210694TT HRP20210694T HRP20210694T1 HR P20210694 T1 HRP20210694 T1 HR P20210694T1 HR P20210694T T HRP20210694T T HR P20210694TT HR P20210694 T HRP20210694 T HR P20210694T HR P20210694 T1 HRP20210694 T1 HR P20210694T1
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Croatia
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preparation
amino acid
acid sequence
use according
seq
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HRP20210694TT
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English (en)
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Ravindra Kumar
John Knopf
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Acceleron Pharma, Inc.
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Publication of HRP20210694T1 publication Critical patent/HRP20210694T1/hr

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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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088—Compounds having three or more nucleosides or nucleotides
    • 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
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/179—Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
    • 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
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1796—Receptors; Cell surface antigens; Cell surface determinants for hormones
    • 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
    • A61K38/1875—Bone morphogenic factor; Osteogenins; Osteogenic factor; Bone-inducing factor
    • 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
    • A61K38/33—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin
    • A61K38/35—Corticotropin [ACTH]
    • 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
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/45—Transferases (2)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K47/50—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
    • A61K47/68—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 antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • 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
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/71—Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Cell Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Toxicology (AREA)
  • Pulmonology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Endocrinology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)

Claims (24)

1. Pripravak za uporabu za liječenje plućne arterijske hipertenzije, naznačen time što obuhvaća ActRIIA polipeptid koji sadrži sekvencu aminokiseline koja je najmanje 80% identična sa sekvencom aminokiseline prema SEQ ID NO: 32.
2. Pripravak za uporabu za liječenje plućne arterijske hipertenzije, naznačen time što obuhvaća ActRIIA polipeptid koji sadrži sekvencu aminokiseline koja je najmanje 80% identična sa sekvencom aminokiseline prema SEQ ID NO: 39.
3. Pripravak za uporabu prema patentnom zahtjevu 1 ili patentnom zahtjevu 2, naznačen time što pacijent ima plućni arterijski tlak (PAP) u mirovanju od najmanje 25 mm Hg.
4. Pripravak za uporabu u skladu s bilo kojim od patentnih zahtjeva 1-3, naznačen time što liječenje smanjuje PAP kod pacijenta; smanjuje hipertrofiju ventrikula kod pacijenta; smanjuje hipertrofiju glatkih mišića kod pacijenta; smanjuje mišićavost plućne arteriole kod pacijenta; smanjuje plućno vaskularni otpor kod pacijenta; snižava plućno vaskularni otpor kod pacijenta; povećava plućni kapilarni tlak; povećava krajnji dijastolički tlak lijeve klijetke; povećava sposobnost vježbanja pacijenta; povećava pacijentovu udaljenost hoda od 6 minuta; i/ili smanjuje pacijentov indeks Borg dispneje (BDI).
5. Pripravak za uporabu u skladu s bilo kojim od patentnih zahtjeva 1-4, naznačen time što pacijent ima plućnu hipertenziju funkcionalne klase II ili III, kao što je priznato od strane Svjetske zdravstvene organizacije.
6. Pripravak za uporabu prema patentnom zahtjevu 5, naznačen time što liječenje sprječava ili odgađa napredovanje funkcionalne klase plućne hipertenzije.
7. Pripravak za uporabu prema patentnom zahtjevu 5 ili 6, naznačen time što liječenje promovira ili povećava regresiju funkcionalne klase plućne hipertenzije.
8. Pripravak za uporabu u skladu s bilo kojim od patentnih zahtjeva 1-7, naznačen time što polipeptid sadrži sekvencu aminokiseline koja je najmanje 85% identična sa sekvencom aminokiseline prema SEQ ID NO: 32.
9. Pripravak za uporabu u skladu s bilo kojim od patentnih zahtjeva 1-8, naznačen time što polipeptid sadrži sekvencu aminokiseline koja je najmanje 90% identična sa sekvencom aminokiseline prema SEQ ID NO: 32.
10. Pripravak za uporabu u skladu s bilo kojim od patentnih zahtjeva 1-9, naznačen time što polipeptid sadrži sekvencu aminokiseline koja je najmanje 95% identična sa sekvencom aminokiseline prema SEQ ID NO: 32.
11. Pripravak za uporabu u skladu s bilo kojim od patentnih zahtjeva 1 ili 3-10, naznačen time što polipeptid sadrži sekvencu aminokiseline koja je najmanje 99% identična sa sekvencom aminokiseline prema SEQ ID NO: 32.
12. Pripravak za uporabu u skladu s bilo kojim od patentnih zahtjeva 1 ili 3-11, naznačen time što polipeptid sadrži sekvencu aminokiseline SEQ ID NO: 32.
13. Pripravak za uporabu u skladu s bilo kojim od patentnih zahtjeva 1 ili 3-12, naznačen time što se polipeptid sastoji od sekvence aminokiseline SEQ ID NO: 32.
14. Pripravak za uporabu u skladu s bilo kojim od patentnih zahtjeva 1-7, naznačen time što polipeptid sadrži sekvencu aminokiseline koja je najmanje 85% identična sa sekvencom aminokiseline prema SEQ ID NO: 39.
15. Pripravak za uporabu u skladu s bilo kojim od patentnih zahtjeva 1-7 ili 14, naznačen time što polipeptid sadrži sekvencu aminokiseline koja je najmanje 90% identična sa sekvencom aminokiseline prema SEQ ID NO: 39.
16. Pripravak za uporabu u skladu s bilo kojim od patentnih zahtjeva 1-7, 14, ili 15, naznačen time što polipeptid sadrži sekvencu aminokiseline koja je najmanje 95% identična sa sekvencom aminokiseline prema SEQ ID NO: 39.
17. Pripravak za uporabu u skladu s bilo kojim od patentnih zahtjeva 2-7 ili 14-16, naznačen time što polipeptid sadrži sekvencu aminokiseline koja je najmanje 99% identična sa sekvencom aminokiseline prema SEQ ID NO: 39.
18. Pripravak za uporabu u skladu s bilo kojim od patentnih zahtjeva 2-7 ili 14-17, naznačen time što polipeptid sadrži sekvencu aminokiseline SEQ ID NO: 39.
19. Pripravak za uporabu u skladu s bilo kojim od patentnih zahtjeva 2-7 ili 14-18, naznačen time što se polipeptid sastoji od sekvence aminokiseline SEQ ID NO: 39.
20. Pripravak za uporabu u skladu s bilo kojim od patentnih zahtjeva 1-19, naznačen time što je polipeptid dio kompleksa homodimer protein.
21. Pripravak za uporabu u skladu s bilo kojim od patentnih zahtjeva 1-20, naznačen time što liječenje nadalje obuhvaća davanje jednog ili više sredstava odabranih iz skupine koja se sastoji od: vazodilatatora, inhibitora fosfodiesteraze tipa 5, stimulatora topive gvanilat ciklaze, agonista receptora prostaciklina i antagonista receptora endotelina.
22. Pripravak za uporabu u skladu s bilo kojim od patentnih zahtjeva 1-21, naznačen time što je pacijent liječen s jednim ili više vazodilatatora.
23. Pripravak za uporabu u skladu s patentnim zahtjevom 21 ili 22, naznačen time što je jedan ili više vazodilatatora odabran iz skupine koju čine: bosentan, sildenafil, beraprost, macitentan, seleksipag, epoprostenol, treprostinil, iloprost, ambrisentan i tadalafil.
24. Pripravak za uporabu u skladu s bilo kojim od patentnih zahtjeva 1-23, naznačen time što se ActRIIA polipeptid veže na jedan ili više liganada odabranih iz skupine koju čine: aktivin A, aktivin B i GDF11.
HRP20210694TT 2016-07-15 2021-05-04 Pripravci koji sadrže actriia polipeptide za uporabu za liječenje plućne hipertenzije HRP20210694T1 (hr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201662362955P 2016-07-15 2016-07-15
US201762453888P 2017-02-02 2017-02-02
US201762510403P 2017-05-24 2017-05-24
PCT/US2017/042157 WO2018013936A1 (en) 2016-07-15 2017-07-14 Compositions and methods for treating pulmonary hypertension
EP17828540.9A EP3496739B1 (en) 2016-07-15 2017-07-14 Compositions comprising actriia polypeptides for use in treating pulmonary hypertension

Publications (1)

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HRP20210694T1 true HRP20210694T1 (hr) 2021-09-17

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HRP20210694TT HRP20210694T1 (hr) 2016-07-15 2021-05-04 Pripravci koji sadrže actriia polipeptide za uporabu za liječenje plućne hipertenzije

Country Status (24)

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US (10) US10722558B2 (hr)
EP (2) EP3928784A1 (hr)
JP (3) JP7220141B2 (hr)
KR (1) KR102512157B1 (hr)
CN (2) CN109689085A (hr)
AU (2) AU2017296040C1 (hr)
CA (1) CA3030859C (hr)
CY (1) CY1124277T1 (hr)
DK (1) DK3496739T3 (hr)
ES (1) ES2875905T3 (hr)
FI (1) FIC20250004I1 (hr)
HR (1) HRP20210694T1 (hr)
HU (2) HUE054228T2 (hr)
LT (1) LT3496739T (hr)
MD (1) MD3496739T2 (hr)
MX (2) MX378869B (hr)
NO (1) NO2025008I1 (hr)
PL (1) PL3496739T3 (hr)
PT (1) PT3496739T (hr)
RS (1) RS62011B1 (hr)
RU (2) RU2021114098A (hr)
SI (1) SI3496739T1 (hr)
SM (1) SMT202100345T1 (hr)
WO (1) WO2018013936A1 (hr)

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