JP2018526403A5 - - Google Patents
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- JP2018526403A5 JP2018526403A5 JP2018512407A JP2018512407A JP2018526403A5 JP 2018526403 A5 JP2018526403 A5 JP 2018526403A5 JP 2018512407 A JP2018512407 A JP 2018512407A JP 2018512407 A JP2018512407 A JP 2018512407A JP 2018526403 A5 JP2018526403 A5 JP 2018526403A5
- Authority
- JP
- Japan
- Prior art keywords
- formulation
- antibody
- intestinal wall
- item
- penetrating member
- 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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- 238000009472 formulation Methods 0.000 claims description 113
- 239000000203 mixture Substances 0.000 claims description 113
- 230000000968 intestinal effect Effects 0.000 claims description 67
- 230000000149 penetrating effect Effects 0.000 claims description 58
- 108010028554 LDL Cholesterol Proteins 0.000 claims description 39
- 239000007787 solid Substances 0.000 claims description 35
- 238000003780 insertion Methods 0.000 claims description 21
- 230000037431 insertion Effects 0.000 claims description 21
- 230000037406 food intake Effects 0.000 claims description 18
- 238000002347 injection Methods 0.000 claims description 13
- 239000007924 injection Substances 0.000 claims description 13
- 230000036470 plasma concentration Effects 0.000 claims description 9
- 230000001225 therapeutic effect Effects 0.000 claims description 9
- 229960002027 evolocumab Drugs 0.000 claims description 8
- 239000000463 material Substances 0.000 claims description 8
- 239000002775 capsule Substances 0.000 claims description 6
- 238000010255 intramuscular injection Methods 0.000 claims description 6
- 239000007927 intramuscular injection Substances 0.000 claims description 6
- 238000010254 subcutaneous injection Methods 0.000 claims description 6
- 239000007929 subcutaneous injection Substances 0.000 claims description 6
- PJRSUKFWFKUDTH-JWDJOUOUSA-N (2s)-6-amino-2-[[2-[[(2s)-2-[[(2s,3s)-2-[[(2s)-2-[[2-[[(2s)-2-[[(2s)-6-amino-2-[[(2s)-2-[[(2s)-2-[[(2s)-2-[(2-aminoacetyl)amino]-4-methylsulfanylbutanoyl]amino]propanoyl]amino]-3-hydroxypropanoyl]amino]hexanoyl]amino]propanoyl]amino]acetyl]amino]propanoyl Chemical compound CSCC[C@H](NC(=O)CN)C(=O)N[C@@H](C)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](C)C(=O)NCC(=O)N[C@@H](C)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](C)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(N)=O PJRSUKFWFKUDTH-JWDJOUOUSA-N 0.000 claims description 4
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 claims description 4
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 claims description 4
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims description 4
- 238000012228 RNA interference-mediated gene silencing Methods 0.000 claims description 4
- 239000011230 binding agent Substances 0.000 claims description 4
- 230000009368 gene silencing by RNA Effects 0.000 claims description 4
- 108010021753 peptide-Gly-Leu-amide Proteins 0.000 claims description 4
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 4
- 229940124531 pharmaceutical excipient Drugs 0.000 claims description 4
- 230000002035 prolonged effect Effects 0.000 claims description 4
- 210000004369 blood Anatomy 0.000 claims description 3
- 239000008280 blood Substances 0.000 claims description 3
- 229950011350 bococizumab Drugs 0.000 claims description 3
- 239000000074 antisense oligonucleotide Substances 0.000 claims description 2
- 238000012230 antisense oligonucleotides Methods 0.000 claims description 2
- GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 claims description 2
- 150000001875 compounds Chemical class 0.000 claims description 2
- 239000007884 disintegrant Substances 0.000 claims description 2
- 239000012530 fluid Substances 0.000 claims description 2
- 239000003112 inhibitor Substances 0.000 claims description 2
- 210000000936 intestine Anatomy 0.000 claims description 2
- 239000008188 pellet Substances 0.000 claims description 2
- 229920001223 polyethylene glycol Polymers 0.000 claims description 2
- 239000003755 preservative agent Substances 0.000 claims description 2
- 230000002335 preservative effect Effects 0.000 claims description 2
- 108090000765 processed proteins & peptides Proteins 0.000 claims description 2
- 150000003384 small molecules Chemical class 0.000 claims description 2
- 108020000948 Antisense Oligonucleotides Proteins 0.000 claims 1
- 102000004196 processed proteins & peptides Human genes 0.000 claims 1
- 210000000813 small intestine Anatomy 0.000 claims 1
- 238000000034 method Methods 0.000 description 56
- 230000004044 response Effects 0.000 description 9
- 101001098868 Homo sapiens Proprotein convertase subtilisin/kexin type 9 Proteins 0.000 description 7
- 102100038955 Proprotein convertase subtilisin/kexin type 9 Human genes 0.000 description 7
- 230000028993 immune response Effects 0.000 description 6
- 210000002966 serum Anatomy 0.000 description 6
- XUKUURHRXDUEBC-KAYWLYCHSA-N Atorvastatin Chemical compound C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CC[C@@H](O)C[C@@H](O)CC(O)=O)C(C(C)C)=C1C(=O)NC1=CC=CC=C1 XUKUURHRXDUEBC-KAYWLYCHSA-N 0.000 description 3
- XUKUURHRXDUEBC-UHFFFAOYSA-N Atorvastatin Natural products C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CCC(O)CC(O)CC(O)=O)C(C(C)C)=C1C(=O)NC1=CC=CC=C1 XUKUURHRXDUEBC-UHFFFAOYSA-N 0.000 description 3
- 229960005370 atorvastatin Drugs 0.000 description 3
- 238000012544 monitoring process Methods 0.000 description 3
- 229940121710 HMGCoA reductase inhibitor Drugs 0.000 description 2
- 102000000704 Interleukin-7 Human genes 0.000 description 2
- 108010002586 Interleukin-7 Proteins 0.000 description 2
- 238000004820 blood count Methods 0.000 description 2
- 239000003638 chemical reducing agent Substances 0.000 description 2
- 230000000260 hypercholesteremic effect Effects 0.000 description 2
- 229940100994 interleukin-7 Drugs 0.000 description 2
- 210000000265 leukocyte Anatomy 0.000 description 2
- 206010003210 Arteriosclerosis Diseases 0.000 description 1
- 208000035150 Hypercholesterolemia Diseases 0.000 description 1
- 108091034117 Oligonucleotide Proteins 0.000 description 1
- 208000031481 Pathologic Constriction Diseases 0.000 description 1
- 208000011775 arteriosclerosis disease Diseases 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 230000002526 effect on cardiovascular system Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000002068 genetic effect Effects 0.000 description 1
- 208000028867 ischemia Diseases 0.000 description 1
- 208000037804 stenosis Diseases 0.000 description 1
- 230000036262 stenosis Effects 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
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 JP2018526403A (ja) | 2018-09-13 |
| JP2018526403A5 true 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) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| 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 |
| DK3624887T3 (da) | 2017-05-17 | 2025-05-19 | Massachusetts Inst Technology | Vævforankringsartikler |
| US11541015B2 (en) | 2017-05-17 | 2023-01-03 | Massachusetts Institute Of Technology | Self-righting systems, methods, and related components |
| 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 |
| BR112021012959A2 (pt) * | 2018-12-31 | 2021-09-08 | Rani Therapeutics, Llc | Preparações de agente terapêutico para a liberação em um lúmen do trato intestinal pela utilização de um dispositivo de liberação de fármaco engolível |
| JP2022523121A (ja) | 2019-02-01 | 2022-04-21 | マサチューセッツ インスティテュート オブ テクノロジー | 液体注入のためのシステムおよび方法 |
| 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 |
| US11541216B2 (en) | 2019-11-21 | 2023-01-03 | Massachusetts Institute Of Technology | Methods for manufacturing tissue interfacing components |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8759284B2 (en) * | 2009-12-24 | 2014-06-24 | Rani Therapeutics, Llc | Therapeutic agent preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device |
| 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 |
| US9149617B2 (en) * | 2010-12-23 | 2015-10-06 | Rani Therapeutics, Llc | Device, system and methods for the oral delivery of therapeutic compounds |
| CN109008910B (zh) * | 2011-06-29 | 2024-07-26 | 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 |
| CA2840487C (en) * | 2011-06-29 | 2022-09-27 | Rani Therapeutics, Llc | Device, system and methods for the oral delivery of therapeutic compounds |
| RU2576034C2 (ru) | 2011-07-14 | 2016-02-27 | Пфайзер Инк. | Лечение антителами против pcsk9 |
| MX2016010504A (es) * | 2014-02-14 | 2016-12-09 | Regeneron Pharma | Metodos para el tratamiento de pacientes con hipercolesterolemia que no esta controlada adecuadamente por una terapia con estatinas de dosis moderada referencia cruzada a solicitudes relacionas. |
| 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 WO PCT/US2016/050832 patent/WO2017044665A1/en not_active Ceased
- 2016-09-08 CN CN201680065019.1A patent/CN108401419A/zh active Pending
- 2016-09-08 JP JP2018512407A patent/JP2018526403A/ja not_active Withdrawn
- 2016-09-08 DK DK16845073.2T patent/DK3347050T3/da active
- 2016-09-08 EP EP16845073.2A patent/EP3347050B1/en active Active
- 2016-09-08 AU AU2016320867A patent/AU2016320867B2/en active Active
- 2016-09-08 CA CA2997958A patent/CA2997958A1/en active Pending
-
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
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