CN108401419A - 使用可吞服药物递送装置递送到肠道内腔中的pcsk9抗体制剂 - Google Patents

使用可吞服药物递送装置递送到肠道内腔中的pcsk9抗体制剂 Download PDF

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Publication number
CN108401419A
CN108401419A CN201680065019.1A CN201680065019A CN108401419A CN 108401419 A CN108401419 A CN 108401419A CN 201680065019 A CN201680065019 A CN 201680065019A CN 108401419 A CN108401419 A CN 108401419A
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CN
China
Prior art keywords
antibody
preparation
patient
intestinal wall
ldl
Prior art date
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Pending
Application number
CN201680065019.1A
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English (en)
Chinese (zh)
Inventor
米尔·伊姆兰
瑞德黑卡·科鲁波鲁
伊莱恩·托
乔尔·哈利斯
米尔·哈什姆
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Rani Therapeutics LLC
Original Assignee
Incube Laboratories LLC
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
Priority claimed from US15/150,379 external-priority patent/US11548940B2/en
Application filed by Incube Laboratories LLC filed Critical Incube Laboratories LLC
Publication of CN108401419A publication Critical patent/CN108401419A/zh
Pending legal-status Critical Current

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against enzymes
    • 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
    • A61K31/713—Double-stranded nucleic acids or oligonucleotides
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs 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
    • 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
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • A61K2039/541—Mucosal route
    • A61K2039/542—Mucosal route oral/gastrointestinal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002—Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, 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)
CN201680065019.1A 2015-09-08 2016-09-08 使用可吞服药物递送装置递送到肠道内腔中的pcsk9抗体制剂 Pending CN108401419A (zh)

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 2016-05-09
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
CN108401419A true CN108401419A (zh) 2018-08-14

Family

ID=58240088

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201680065019.1A Pending CN108401419A (zh) 2015-09-08 2016-09-08 使用可吞服药物递送装置递送到肠道内腔中的pcsk9抗体制剂

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=)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113543756A (zh) * 2018-12-31 2021-10-22 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
CN114007638A (zh) * 2019-05-03 2022-02-01 拉尼医疗有限公司 使用可吞咽药物递送设备递送到肠道中的凝血因子制剂
US12128133B2 (en) 2018-09-25 2024-10-29 Rani Therapeutics, Llc Ingestible device with expandable enclosure

Families Citing this family (7)

* 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
EP4696361A3 (en) 2019-02-01 2026-04-15 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 (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102905753A (zh) * 2009-12-24 2013-01-30 因卡伯实验室有限责任公司 可吞咽式药剂递送装置和药剂递送方法
US20140221912A1 (en) * 2009-12-24 2014-08-07 Rani Therapeutics, Llc Swallowable drug delivery device and methods of drug delivery
CN104023740A (zh) * 2011-06-29 2014-09-03 拉尼医疗有限公司 用于使用可吞服药物递送装置递送到肠道内腔中的治疗药剂制剂
CN104093423A (zh) * 2011-07-14 2014-10-08 辉瑞公司 使用抗pcsk9抗体的治疗

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9149617B2 (en) * 2010-12-23 2015-10-06 Rani Therapeutics, Llc Device, system and methods for the oral delivery of therapeutic compounds
PT3653223T (pt) * 2011-06-29 2021-12-06 Rani Therapeutics Llc Dispositivo para a entrega oral de compostos terapêuticos
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

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102905753A (zh) * 2009-12-24 2013-01-30 因卡伯实验室有限责任公司 可吞咽式药剂递送装置和药剂递送方法
US20140221912A1 (en) * 2009-12-24 2014-08-07 Rani Therapeutics, Llc Swallowable drug delivery device and methods of drug delivery
CN104023740A (zh) * 2011-06-29 2014-09-03 拉尼医疗有限公司 用于使用可吞服药物递送装置递送到肠道内腔中的治疗药剂制剂
CN104093423A (zh) * 2011-07-14 2014-10-08 辉瑞公司 使用抗pcsk9抗体的治疗

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12128133B2 (en) 2018-09-25 2024-10-29 Rani Therapeutics, Llc Ingestible device with expandable enclosure
CN113543756A (zh) * 2018-12-31 2021-10-22 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
CN113543756B (zh) * 2018-12-31 2023-09-05 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
CN114007638A (zh) * 2019-05-03 2022-02-01 拉尼医疗有限公司 使用可吞咽药物递送设备递送到肠道中的凝血因子制剂

Also Published As

Publication number Publication date
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
DK3347050T3 (da) 2025-04-14
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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Applicant after: Rani Therapeutics, LLC

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Applicant before: INCUBE LABS, LLC

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