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
Other languages
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 [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/40Immunoglobulins [IG], 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)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Immunology (AREA)
  • Urology & Nephrology (AREA)
  • Anesthesiology (AREA)
  • Genetics & Genomics (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Obesity (AREA)
  • Cardiology (AREA)
  • Diabetes (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (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 (https=)
JP (3) JP2018526403A (https=)
CN (1) CN108401419A (https=)
AU (2) AU2016320867B2 (https=)
CA (1) CA2997958A1 (https=)
DK (1) DK3347050T3 (https=)
WO (1) WO2017044665A1 (https=)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
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
WO2018213579A1 (en) 2017-05-17 2018-11-22 Massachusetts Institute Of Technology Self-actuating articles
US11541015B2 (en) 2017-05-17 2023-01-03 Massachusetts Institute Of Technology Self-righting systems, methods, and related components
AU2019269636A1 (en) 2018-05-17 2020-11-19 Massachusetts Institute Of Technology Systems for electrical stimulation
US12128133B2 (en) 2018-09-25 2024-10-29 Rani Therapeutics, Llc Ingestible device with expandable enclosure
CN117100683A (zh) * 2018-12-31 2023-11-24 拉尼医疗有限公司 使用可吞服药物递送装置递送到肠道内腔的治疗剂制剂
EP4696361A3 (en) 2019-02-01 2026-04-15 Massachusetts Institute of Technology Systems and methods for liquid injection
EP3962516B1 (en) * 2019-05-03 2026-04-29 Rani Therapeutics, LLC Clotting factor viii preparations for delivery through tissue of the intestinal tract using a swallowable 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
CA2785168C (en) * 2009-12-24 2018-04-17 Incube Labs, Llc Swallowable drug delivery device and methods of drug delivery
US8721620B2 (en) * 2009-12-24 2014-05-13 Rani Therapeutics, Llc Swallowable drug delivery device and methods of drug delivery
US9149617B2 (en) * 2010-12-23 2015-10-06 Rani Therapeutics, Llc Device, system and methods for the oral delivery of therapeutic compounds
ES2773115T3 (es) * 2011-06-29 2020-07-09 Rani Therapeutics Llc Preparados de agentes terapéuticos para la administración hacia el interior de una luz del tubo intestinal utilizando un dispositivo tragable para la administración de fármacos
PT3653223T (pt) * 2011-06-29 2021-12-06 Rani Therapeutics Llc Dispositivo para a entrega oral de compostos terapêuticos
CN104093423A (zh) 2011-07-14 2014-10-08 辉瑞公司 使用抗pcsk9抗体的治疗
CN106029096A (zh) 2014-02-14 2016-10-12 瑞泽恩制药公司 用于治疗具有未被中等剂量他汀疗法充分控制的高胆固醇血症的患者的方法
AU2016261599B2 (en) * 2015-05-08 2021-08-26 Rani Therapeutics, 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
CN108401419A (zh) 2018-08-14
JP2018526403A (ja) 2018-09-13
AU2023204153A1 (en) 2023-07-20
EP3347050A1 (en) 2018-07-18
AU2016320867A1 (en) 2018-04-05
WO2017044665A1 (en) 2017-03-16
JP2021169530A (ja) 2021-10-28
EP3347050A4 (en) 2019-05-22
CA2997958A1 (en) 2017-03-16
EP3347050B1 (en) 2025-01-15
JP2023104992A (ja) 2023-07-28
AU2016320867B2 (en) 2023-03-30

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