JP2018526403A - 嚥下可能な薬物送達デバイスを使用する腸管の管腔中への送達のためのpcsk9抗体製剤 - Google Patents

嚥下可能な薬物送達デバイスを使用する腸管の管腔中への送達のためのpcsk9抗体製剤 Download PDF

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JP2018526403A
JP2018526403A JP2018512407A JP2018512407A JP2018526403A JP 2018526403 A JP2018526403 A JP 2018526403A JP 2018512407 A JP2018512407 A JP 2018512407A JP 2018512407 A JP2018512407 A JP 2018512407A JP 2018526403 A JP2018526403 A JP 2018526403A
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antibody
formulation
patient
penetrating member
intestinal wall
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JP2018526403A5 (enExample
Inventor
ミル イムラン,
ミル イムラン,
ラディカ コルポル,
ラディカ コルポル,
エレイン トー,
エレイン トー,
ジョエル ハリス,
ジョエル ハリス,
ミル ハシム,
ミル ハシム,
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インキューブ ラブズ, エルエルシー
インキューブ ラブズ, エルエルシー
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Publication of JP2018526403A publication Critical patent/JP2018526403A/ja
Publication of JP2018526403A5 publication Critical patent/JP2018526403A5/ja
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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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biochemistry (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Vascular Medicine (AREA)
  • Immunology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Anesthesiology (AREA)
  • Cardiology (AREA)
  • Microbiology (AREA)
  • Obesity (AREA)
  • Diabetes (AREA)
  • Urology & Nephrology (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2018512407A 2015-09-08 2016-09-08 嚥下可能な薬物送達デバイスを使用する腸管の管腔中への送達のためのpcsk9抗体製剤 Withdrawn JP2018526403A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2021125408A JP2021169530A (ja) 2015-09-08 2021-07-30 嚥下可能な薬物送達デバイスを使用する腸管の管腔中への送達のためのpcsk9抗体製剤

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201562215586P 2015-09-08 2015-09-08
US62/215,586 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
US15/150,379 2016-05-09
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

Related Child Applications (1)

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JP2021125408A Division JP2021169530A (ja) 2015-09-08 2021-07-30 嚥下可能な薬物送達デバイスを使用する腸管の管腔中への送達のためのpcsk9抗体製剤

Publications (2)

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JP2018526403A true JP2018526403A (ja) 2018-09-13
JP2018526403A5 JP2018526403A5 (enExample) 2019-10-03

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JP2018512407A Withdrawn JP2018526403A (ja) 2015-09-08 2016-09-08 嚥下可能な薬物送達デバイスを使用する腸管の管腔中への送達のためのpcsk9抗体製剤
JP2021125408A Pending JP2021169530A (ja) 2015-09-08 2021-07-30 嚥下可能な薬物送達デバイスを使用する腸管の管腔中への送達のためのpcsk9抗体製剤
JP2023084891A Pending JP2023104992A (ja) 2015-09-08 2023-05-23 嚥下可能な薬物送達デバイスを使用する腸管の管腔中への送達のためのpcsk9抗体製剤

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JP2021125408A Pending JP2021169530A (ja) 2015-09-08 2021-07-30 嚥下可能な薬物送達デバイスを使用する腸管の管腔中への送達のためのpcsk9抗体製剤
JP2023084891A Pending JP2023104992A (ja) 2015-09-08 2023-05-23 嚥下可能な薬物送達デバイスを使用する腸管の管腔中への送達のためのpcsk9抗体製剤

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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)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2022516513A (ja) * 2018-12-31 2022-02-28 ラニ セラピューティクス, エルエルシー 嚥下可能薬物送達デバイスを使用する腸管の管腔への送達のための治療剤調製物
JP2022530615A (ja) * 2019-05-03 2022-06-30 ラニ セラピューティクス, エルエルシー 嚥下可能な薬物送達デバイスを使用する腸管の組織への送達のための凝固因子調製物

Families Citing this family (8)

* 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
CA2949236C (en) 2014-05-15 2023-06-13 Incube Labs, Llc Pharmaceutical compositions and methods for fabrication of solid masses comprising polypeptides and/or proteins
KR102647155B1 (ko) 2017-05-17 2024-03-15 메사추세츠 인스티튜트 오브 테크놀로지 자가-직립 물품
US11541015B2 (en) 2017-05-17 2023-01-03 Massachusetts Institute Of Technology Self-righting systems, methods, and related components
CA3100710A1 (en) 2018-05-17 2019-11-21 Massachusetts Institute Of Technology Systems for electrical stimulation
US12128133B2 (en) 2018-09-25 2024-10-29 Rani Therapeutics, Llc Ingestible device with expandable enclosure
WO2020160399A1 (en) 2019-02-01 2020-08-06 Massachusetts Institute Of Technology Systems and methods for liquid injection
US11541216B2 (en) 2019-11-21 2023-01-03 Massachusetts Institute Of Technology Methods for manufacturing tissue interfacing components

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013515576A (ja) * 2009-12-24 2013-05-09 インキューブ ラブズ, エルエルシー 嚥下可能薬物送達デバイスおよび薬物送達方法
JP2014520812A (ja) * 2011-06-29 2014-08-25 ラニ セラピューティクス, エルエルシー 嚥下可能な薬物送達デバイスを用いる腸管の内腔へ送達するための治療剤製剤
JP2014520600A (ja) * 2011-06-29 2014-08-25 ラニ セラピューティクス, エルエルシー 治療用化合物の経口送達のためのデバイス、システム、および方法

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
JP2013023499A (ja) * 2011-07-14 2013-02-04 Pfizer Inc 抗pcsk9抗体を用いた処置
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
CN107835682A (zh) * 2015-05-08 2018-03-23 因库博实验室有限责任公司 使用可吞服药物递送装置递送至肠道内腔的抗白细胞介素抗体制剂

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013515576A (ja) * 2009-12-24 2013-05-09 インキューブ ラブズ, エルエルシー 嚥下可能薬物送達デバイスおよび薬物送達方法
JP2014520812A (ja) * 2011-06-29 2014-08-25 ラニ セラピューティクス, エルエルシー 嚥下可能な薬物送達デバイスを用いる腸管の内腔へ送達するための治療剤製剤
JP2014520600A (ja) * 2011-06-29 2014-08-25 ラニ セラピューティクス, エルエルシー 治療用化合物の経口送達のためのデバイス、システム、および方法

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
GENCER B ET AL.: "PCSK9 inhibitors", SWISS MEDICAL WEEKLY, vol. 145, JPN6020028456, 9 April 2015 (2015-04-09), pages 14094, ISSN: 0004475655 *
小泉 直也: "ペプチド医薬品の経口投与製剤開発のための基礎検討", 上原記念生命科学財団研究報告集,[ONLINE], vol. 第27巻, JPN6020028459, 2013, ISSN: 0004475656 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2022516513A (ja) * 2018-12-31 2022-02-28 ラニ セラピューティクス, エルエルシー 嚥下可能薬物送達デバイスを使用する腸管の管腔への送達のための治療剤調製物
JP2022530615A (ja) * 2019-05-03 2022-06-30 ラニ セラピューティクス, エルエルシー 嚥下可能な薬物送達デバイスを使用する腸管の組織への送達のための凝固因子調製物
JP7692363B2 (ja) 2019-05-03 2025-06-13 ラニ セラピューティクス, エルエルシー 嚥下可能な薬物送達デバイスを使用する腸管の組織への送達のための凝固因子調製物

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Publication number Publication date
CA2997958A1 (en) 2017-03-16
CN108401419A (zh) 2018-08-14
AU2023204153A1 (en) 2023-07-20
EP3347050B1 (en) 2025-01-15
EP3347050A4 (en) 2019-05-22
JP2021169530A (ja) 2021-10-28
WO2017044665A1 (en) 2017-03-16
DK3347050T3 (da) 2025-04-14
AU2016320867A1 (en) 2018-04-05
AU2016320867B2 (en) 2023-03-30
EP3347050A1 (en) 2018-07-18
JP2023104992A (ja) 2023-07-28

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