DK3347050T3 - PCSK9-antistofpræparater til afgivelse i et lumen i mave-tarmkanalen ved hjælp af en indtagelig enhed til afgivelse af lægemiddel - Google Patents

PCSK9-antistofpræparater til afgivelse i et lumen i mave-tarmkanalen ved hjælp af en indtagelig enhed til afgivelse af lægemiddel Download PDF

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Publication number
DK3347050T3
DK3347050T3 DK16845073.2T DK16845073T DK3347050T3 DK 3347050 T3 DK3347050 T3 DK 3347050T3 DK 16845073 T DK16845073 T DK 16845073T DK 3347050 T3 DK3347050 T3 DK 3347050T3
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Prior art keywords
lumen
gastrointestinal tract
antibody compositions
pcsk9 antibody
delivery device
Prior art date
Application number
DK16845073.2T
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Danish (da)
English (en)
Inventor
Mir Imran
Radhika Korupolu
Elaine To
Joel Harris
Mir Hashim
Original Assignee
Rani Therapeutics Llc
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Filing date
Publication date
Priority claimed from US15/150,379 external-priority patent/US11548940B2/en
Application filed by Rani Therapeutics Llc filed Critical Rani Therapeutics Llc
Application granted granted Critical
Publication of DK3347050T3 publication Critical patent/DK3347050T3/da

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088Compounds having three or more nucleosides or nucleotides
    • A61K31/713Double-stranded nucleic acids or oligonucleotides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891Coated capsules; Multilayered drug free capsule shells
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • A61K2039/541Mucosal route
    • A61K2039/542Mucosal route oral/gastrointestinal
    • 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
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Vascular Medicine (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Urology & Nephrology (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Anesthesiology (AREA)
  • Obesity (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Mycology (AREA)
  • Cardiology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Materials For Medical Uses (AREA)
DK16845073.2T 2015-09-08 2016-09-08 PCSK9-antistofpræparater til afgivelse i et lumen i mave-tarmkanalen ved hjælp af en indtagelig enhed til afgivelse af lægemiddel DK3347050T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562215586P 2015-09-08 2015-09-08
US15/150,379 US11548940B2 (en) 2014-05-15 2016-05-09 Anti-interleukin antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
PCT/US2016/050832 WO2017044665A1 (en) 2015-09-08 2016-09-08 Pcsk9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device

Publications (1)

Publication Number Publication Date
DK3347050T3 true DK3347050T3 (da) 2025-04-14

Family

ID=58240088

Family Applications (1)

Application Number Title Priority Date Filing Date
DK16845073.2T DK3347050T3 (da) 2015-09-08 2016-09-08 PCSK9-antistofpræparater til afgivelse i et lumen i mave-tarmkanalen ved hjælp af en indtagelig enhed til afgivelse af lægemiddel

Country Status (7)

Country Link
EP (1) EP3347050B1 (enExample)
JP (3) JP2018526403A (enExample)
CN (1) CN108401419A (enExample)
AU (2) AU2016320867B2 (enExample)
CA (1) CA2997958A1 (enExample)
DK (1) DK3347050T3 (enExample)
WO (1) WO2017044665A1 (enExample)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3142645A4 (en) 2014-05-15 2017-12-27 Rani Therapeutics, LLC Pharmaceutical compositions and methods for fabrication of solid masses comprising polypeptides and/or proteins
US10689460B2 (en) 2014-05-15 2020-06-23 Incube Labs, Llc PCSK9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US11541015B2 (en) 2017-05-17 2023-01-03 Massachusetts Institute Of Technology Self-righting systems, methods, and related components
IL301683B2 (en) 2017-05-17 2025-02-01 Massachusetts Inst Technology Self-healing systems and related components and methods
EP3793667A1 (en) 2018-05-17 2021-03-24 Massachusetts Institute of Technology Systems for electrical stimulation
US12128133B2 (en) 2018-09-25 2024-10-29 Rani Therapeutics, Llc Ingestible device with expandable enclosure
EP3905999A4 (en) * 2018-12-31 2022-09-28 Rani Therapeutics, LLC THERAPEUTIC AGENT PREPARATIONS TO BE DELIVERED INTO A Lumen OF THE INTESTINAL TRACT BY MEANS OF A SWALLOWED DRUG DELIVERY DEVICE
US11771829B2 (en) 2019-02-01 2023-10-03 Massachusetts Institute Of Technology Systems and methods for liquid injection
EP3962516A4 (en) * 2019-05-03 2023-01-04 Rani Therapeutics, LLC COAGAGING FACTOR PREPARATIONS FOR ADMINISTRATION INTO TISSUES OF THE INTESTINAL TRACT USING AN INGESTIONABLE DRUG DELIVERY DEVICE
US11541216B2 (en) 2019-11-21 2023-01-03 Massachusetts Institute Of Technology Methods for manufacturing tissue interfacing components

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2010336330B2 (en) * 2009-12-24 2016-04-28 Rani Therapeutics, Llc Swallowable drug delivery device and methods of drug delivery
US8562589B2 (en) * 2009-12-24 2013-10-22 Rani Therapeutics, Llc Swallowable drug delivery device and method of delivery
US9149617B2 (en) 2010-12-23 2015-10-06 Rani Therapeutics, Llc Device, system and methods for the oral delivery of therapeutic compounds
PL2726091T3 (pl) * 2011-06-29 2020-08-10 Rani Therapeutics, Llc Preparaty lecznicze dostarczane do kanału przewodu jelitowego za pomocą połykalnego urządzenia dostarczającego lek
PL3653223T3 (pl) * 2011-06-29 2021-12-20 Rani Therapeutics, Llc Urządzenie do doustnego dostarczania związków leczniczych
HK1202804A1 (en) * 2011-07-14 2015-10-09 辉瑞公司 Treatment with anti-pcsk9 antibodies
CA2939507A1 (en) * 2014-02-14 2015-08-20 Regeneron Pharmaceuticals, Inc. Methods for treating patients with hypercholesterolemia that is not adequately controlled by moderate-dose statin therapy
CA2984422C (en) * 2015-05-08 2023-10-17 Incube Labs, Llc Anti-interleukin antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device

Also Published As

Publication number Publication date
AU2016320867B2 (en) 2023-03-30
JP2021169530A (ja) 2021-10-28
JP2023104992A (ja) 2023-07-28
CN108401419A (zh) 2018-08-14
EP3347050A1 (en) 2018-07-18
WO2017044665A1 (en) 2017-03-16
EP3347050B1 (en) 2025-01-15
CA2997958A1 (en) 2017-03-16
JP2018526403A (ja) 2018-09-13
AU2016320867A1 (en) 2018-04-05
AU2023204153A1 (en) 2023-07-20
EP3347050A4 (en) 2019-05-22

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