JP2018520995A5 - - Google Patents
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- Publication number
- JP2018520995A5 JP2018520995A5 JP2017557954A JP2017557954A JP2018520995A5 JP 2018520995 A5 JP2018520995 A5 JP 2018520995A5 JP 2017557954 A JP2017557954 A JP 2017557954A JP 2017557954 A JP2017557954 A JP 2017557954A JP 2018520995 A5 JP2018520995 A5 JP 2018520995A5
- Authority
- JP
- Japan
- Prior art keywords
- antibody
- item
- formulation
- formulation according
- 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.)
- Granted
Links
- 108090001123 antibodies Proteins 0.000 claims description 147
- 102000004965 antibodies Human genes 0.000 claims description 147
- 238000009472 formulation Methods 0.000 claims description 66
- 239000000203 mixture Substances 0.000 claims description 66
- 230000000968 intestinal Effects 0.000 claims description 45
- 210000001519 tissues Anatomy 0.000 claims description 37
- 238000002347 injection Methods 0.000 claims description 35
- 239000007924 injection Substances 0.000 claims description 35
- 230000000149 penetrating Effects 0.000 claims description 34
- 239000007787 solid Substances 0.000 claims description 34
- 230000001225 therapeutic Effects 0.000 claims description 26
- 230000000051 modifying Effects 0.000 claims description 21
- 102000013691 Interleukin-17 Human genes 0.000 claims description 20
- 108050003558 Interleukin-17 family Proteins 0.000 claims description 20
- 206010067484 Adverse reaction Diseases 0.000 claims description 15
- 238000002360 preparation method Methods 0.000 claims description 12
- 230000037406 food intake Effects 0.000 claims description 10
- 238000003780 insertion Methods 0.000 claims description 9
- 230000002829 reduced Effects 0.000 claims description 9
- 208000003455 Anaphylaxis Diseases 0.000 claims description 8
- 102000015696 Interleukins Human genes 0.000 claims description 8
- 108010063738 Interleukins Proteins 0.000 claims description 8
- 239000002775 capsule Substances 0.000 claims description 8
- 230000036470 plasma concentration Effects 0.000 claims description 7
- 230000004044 response Effects 0.000 claims description 7
- 230000035839 C max Effects 0.000 claims description 6
- 230000000770 pro-inflamatory Effects 0.000 claims description 6
- 238000006065 biodegradation reaction Methods 0.000 claims description 5
- 239000000463 material Substances 0.000 claims description 5
- 230000035515 penetration Effects 0.000 claims description 5
- 238000010254 subcutaneous injection Methods 0.000 claims description 5
- 239000007929 subcutaneous injection Substances 0.000 claims description 5
- 206010002198 Anaphylactic reaction Diseases 0.000 claims description 4
- 206010002199 Anaphylactic shock Diseases 0.000 claims description 4
- 206010019233 Headache Diseases 0.000 claims description 4
- 206010022095 Injection site reaction Diseases 0.000 claims description 4
- 206010030113 Oedema Diseases 0.000 claims description 4
- 230000031018 biological processes and functions Effects 0.000 claims description 4
- 238000006243 chemical reaction Methods 0.000 claims description 4
- 231100000869 headache Toxicity 0.000 claims description 4
- 230000002163 immunogen Effects 0.000 claims description 3
- 102000004127 Cytokines Human genes 0.000 claims description 2
- 108090000695 Cytokines Proteins 0.000 claims description 2
- 230000002238 attenuated Effects 0.000 claims description 2
- 230000004071 biological effect Effects 0.000 claims description 2
- 201000010099 disease Diseases 0.000 description 12
- 230000035852 Tmax Effects 0.000 description 8
- 230000000694 effects Effects 0.000 description 8
- 230000028993 immune response Effects 0.000 description 6
- 230000037242 Cmax Effects 0.000 description 4
- 229940047122 Interleukins Drugs 0.000 description 4
- GUBGYTABKSRVRQ-YOLKTULGSA-N Maltose Natural products O([C@@H]1[C@H](O)[C@@H](O)[C@H](O)O[C@H]1CO)[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 GUBGYTABKSRVRQ-YOLKTULGSA-N 0.000 description 4
- 210000000440 Neutrophils Anatomy 0.000 description 4
- 238000010255 intramuscular injection Methods 0.000 description 4
- 239000007927 intramuscular injection Substances 0.000 description 4
- 210000000813 small intestine Anatomy 0.000 description 4
- 206010020751 Hypersensitivity Diseases 0.000 description 3
- 210000001986 Peyer's Patches Anatomy 0.000 description 3
- 206010037162 Psoriatic arthropathy Diseases 0.000 description 3
- 201000004681 psoriasis Diseases 0.000 description 3
- 201000001263 psoriatic arthritis Diseases 0.000 description 3
- 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 description 2
- 206010002556 Ankylosing spondylitis Diseases 0.000 description 2
- 206010011401 Crohn's disease Diseases 0.000 description 2
- 210000001198 Duodenum Anatomy 0.000 description 2
- 210000003979 Eosinophils Anatomy 0.000 description 2
- 102100008982 IL17A Human genes 0.000 description 2
- 101710003110 IL17A Proteins 0.000 description 2
- 206010021972 Inflammatory bowel disease Diseases 0.000 description 2
- 210000004185 Liver Anatomy 0.000 description 2
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 2
- 210000003240 Portal Vein Anatomy 0.000 description 2
- 206010039073 Rheumatoid arthritis Diseases 0.000 description 2
- 210000004027 cells Anatomy 0.000 description 2
- 230000002401 inhibitory effect Effects 0.000 description 2
- 239000000546 pharmaceutic aid Substances 0.000 description 2
- 210000004369 Blood Anatomy 0.000 description 1
- 229960005435 Ixekizumab Drugs 0.000 description 1
- 210000001630 Jejunum Anatomy 0.000 description 1
- 239000011230 binding agent Substances 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 239000007884 disintegrant Substances 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 108010063443 ixekizumab Proteins 0.000 description 1
- 239000008188 pellet Substances 0.000 description 1
- 230000002335 preservative Effects 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 230000000152 swallowing Effects 0.000 description 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201562159134P | 2015-05-08 | 2015-05-08 | |
| US62/159,134 | 2015-05-08 | ||
| PCT/US2016/031548 WO2016183040A1 (en) | 2015-05-08 | 2016-05-09 | Anti-interleukin 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 |
|---|---|---|---|
| JP2020196688A Division JP7232805B2 (ja) | 2015-05-08 | 2020-11-27 | 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抗インターロイキン抗体製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2018520995A JP2018520995A (ja) | 2018-08-02 |
| JP2018520995A5 true JP2018520995A5 (de) | 2019-06-13 |
| JP7185401B2 JP7185401B2 (ja) | 2022-12-07 |
Family
ID=57248408
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017557954A Active JP7185401B2 (ja) | 2015-05-08 | 2016-05-09 | 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抗インターロイキン抗体製剤 |
| JP2020196688A Active JP7232805B2 (ja) | 2015-05-08 | 2020-11-27 | 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抗インターロイキン抗体製剤 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020196688A Active JP7232805B2 (ja) | 2015-05-08 | 2020-11-27 | 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抗インターロイキン抗体製剤 |
Country Status (6)
| Country | Link |
|---|---|
| EP (1) | EP3294273A4 (de) |
| JP (2) | JP7185401B2 (de) |
| CN (1) | CN107835682A (de) |
| AU (2) | AU2016261599B2 (de) |
| CA (1) | CA2984422C (de) |
| WO (1) | WO2016183040A1 (de) |
Families Citing this family (5)
| 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 |
| US11548940B2 (en) | 2014-05-15 | 2023-01-10 | Rani Therapeutics, Llc | Anti-interleukin antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device |
| CN108401419A (zh) * | 2015-09-08 | 2018-08-14 | 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到肠道内腔中的pcsk9抗体制剂 |
| EP3554343A1 (de) * | 2016-12-14 | 2019-10-23 | Progenity, Inc. | Behandlung einer erkrankung des gastrointestinaltraktes mit einem il-1-inhibitor |
| 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 |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS6024767B2 (ja) * | 1979-08-24 | 1985-06-14 | 塩野義製薬株式会社 | 腸溶性硬カプセル剤 |
| WO2006052660A2 (en) * | 2004-11-04 | 2006-05-18 | Childrens Hospital Los Angeles Research Institute | Il-7 receptor blockade to suppress immunity |
| US20100004157A1 (en) * | 2006-09-12 | 2010-01-07 | Cosmo Technologies Ltd. | Pharmaceutical compositions for the oral or rectal administration of protein substances |
| GB0722484D0 (en) * | 2007-11-15 | 2007-12-27 | Ucl Business Plc | Solid compositions |
| US8721620B2 (en) * | 2009-12-24 | 2014-05-13 | Rani Therapeutics, Llc | Swallowable drug delivery device and methods of drug delivery |
| CN105999526B (zh) * | 2009-12-24 | 2019-07-05 | 拉尼医疗有限公司 | 可吞咽式药剂递送装置和药剂递送方法 |
| US8524215B2 (en) * | 2010-08-02 | 2013-09-03 | Janssen Biotech, Inc. | Absorbable PEG-based hydrogels |
| US9149617B2 (en) * | 2010-12-23 | 2015-10-06 | Rani Therapeutics, Llc | Device, system and methods for the oral delivery of therapeutic compounds |
| US8980822B2 (en) * | 2010-12-23 | 2015-03-17 | Rani Therapeutics, Llc | Therapeutic agent preparations comprising pramlintide for delivery into a lumen of the intestinal tract using a swallowable drug delivery device |
| EP3653224A1 (de) * | 2011-06-29 | 2020-05-20 | Rani Therapeutics, LLC | Therapeutikumpräparate zur freisetzung in ein lumen des darmtraktes mittels einnehmbarer wirkstofffreisetzungsvorrichtung |
| ES2765029T3 (es) * | 2011-06-29 | 2020-06-05 | Rani Therapeutics Llc | Dispositivo, sistema y métodos para la administración por vía oral de compuestos terapéuticos |
| RU2015119547A (ru) * | 2012-10-25 | 2016-12-20 | МЕДИММЬЮН, ЭлЭлСи | Стабильный низковязкий состав с антителом |
| US20150064241A1 (en) * | 2013-09-05 | 2015-03-05 | Google Inc. | Delivery of Functionalized Particles |
| WO2015176031A2 (en) * | 2014-05-15 | 2015-11-19 | Incube Labs, Llc | Pharmaceutical compositions and methods for fabrication of solid masses comprising polypeptides and/or proteins |
| CA2983337A1 (en) * | 2015-05-01 | 2016-11-10 | Incube Labs, Llc | Pharmaceutical compositions and methods for fabrication of solid masses comprising polypeptides and/or proteins |
-
2016
- 2016-05-09 JP JP2017557954A patent/JP7185401B2/ja active Active
- 2016-05-09 CN CN201680040187.5A patent/CN107835682A/zh active Pending
- 2016-05-09 AU AU2016261599A patent/AU2016261599B2/en active Active
- 2016-05-09 EP EP16793347.2A patent/EP3294273A4/de active Pending
- 2016-05-09 CA CA2984422A patent/CA2984422C/en active Active
- 2016-05-09 WO PCT/US2016/031548 patent/WO2016183040A1/en unknown
-
2020
- 2020-11-27 JP JP2020196688A patent/JP7232805B2/ja active Active
-
2021
- 2021-11-22 AU AU2021269453A patent/AU2021269453A1/en active Pending
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