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 PDFInfo
- Publication number
- 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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- JP
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- Prior art keywords
- antibody
- formulation
- patient
- penetrating member
- intestinal wall
- Prior art date
- Legal status (The legal status 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 status listed.)
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Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/40—Immunoglobulins [IGs], 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)
- 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)
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)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| 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)
| Publication Number | Publication Date |
|---|---|
| JP2018526403A true JP2018526403A (ja) | 2018-09-13 |
| JP2018526403A5 JP2018526403A5 (enExample) | 2019-10-03 |
Family
ID=58240088
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| 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 |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| 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 |
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) |
Cited By (2)
| 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)
| 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)
| 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)
| 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 |
-
2016
- 2016-09-08 JP JP2018512407A patent/JP2018526403A/ja not_active Withdrawn
- 2016-09-08 EP EP16845073.2A patent/EP3347050B1/en active Active
- 2016-09-08 CA CA2997958A patent/CA2997958A1/en active Pending
- 2016-09-08 CN CN201680065019.1A patent/CN108401419A/zh active Pending
- 2016-09-08 DK DK16845073.2T patent/DK3347050T3/da active
- 2016-09-08 AU AU2016320867A patent/AU2016320867B2/en active Active
- 2016-09-08 WO PCT/US2016/050832 patent/WO2017044665A1/en not_active Ceased
-
2021
- 2021-07-30 JP JP2021125408A patent/JP2021169530A/ja active Pending
-
2023
- 2023-05-23 JP JP2023084891A patent/JP2023104992A/ja active Pending
- 2023-06-29 AU AU2023204153A patent/AU2023204153A1/en active Pending
Patent Citations (3)
| 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)
| 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)
| 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 |
Also Published As
| 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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