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
- 238000009472 formulation Methods 0.000 claims description 66
- 239000000203 mixture Substances 0.000 claims description 66
- 230000000968 intestinal effect Effects 0.000 claims description 43
- 238000002347 injection Methods 0.000 claims description 35
- 239000007924 injection Substances 0.000 claims description 35
- 230000000149 penetrating effect Effects 0.000 claims description 34
- 239000007787 solid Substances 0.000 claims description 34
- 102000013691 Interleukin-17 Human genes 0.000 claims description 22
- 108050003558 Interleukin-17 Proteins 0.000 claims description 22
- 206010067484 Adverse reaction Diseases 0.000 claims description 15
- 230000006838 adverse reaction Effects 0.000 claims description 15
- 231100001274 therapeutic index Toxicity 0.000 claims description 14
- 230000001225 therapeutic effect Effects 0.000 claims description 12
- 230000037406 food intake Effects 0.000 claims description 10
- 238000003780 insertion Methods 0.000 claims description 9
- 230000037431 insertion Effects 0.000 claims description 9
- 230000002829 reductive effect Effects 0.000 claims description 9
- 102000015696 Interleukins Human genes 0.000 claims description 8
- 108010063738 Interleukins Proteins 0.000 claims description 8
- 208000003455 anaphylaxis Diseases 0.000 claims description 8
- 230000004071 biological effect Effects 0.000 claims description 8
- 239000002775 capsule Substances 0.000 claims description 8
- 230000036470 plasma concentration Effects 0.000 claims description 7
- 230000007112 pro inflammatory response Effects 0.000 claims description 6
- 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 Headaches 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
- 231100000869 headache Toxicity 0.000 claims description 4
- 102000004127 Cytokines Human genes 0.000 claims description 3
- 108090000695 Cytokines Proteins 0.000 claims description 3
- 230000009851 immunogenic response Effects 0.000 claims description 3
- 230000002238 attenuated effect Effects 0.000 claims description 2
- 238000000034 method Methods 0.000 description 62
- 210000001519 tissue Anatomy 0.000 description 31
- 201000010099 disease Diseases 0.000 description 12
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 12
- 230000028993 immune response Effects 0.000 description 6
- 229940047122 interleukins Drugs 0.000 description 4
- 238000010255 intramuscular injection Methods 0.000 description 4
- 239000007927 intramuscular injection Substances 0.000 description 4
- 210000000440 neutrophil Anatomy 0.000 description 4
- 210000000813 small intestine Anatomy 0.000 description 4
- 206010020751 Hypersensitivity Diseases 0.000 description 3
- 201000004681 Psoriasis Diseases 0.000 description 3
- 201000001263 Psoriatic Arthritis Diseases 0.000 description 3
- 208000036824 Psoriatic arthropathy Diseases 0.000 description 3
- 208000030961 allergic reaction Diseases 0.000 description 3
- 210000001986 peyer's patch Anatomy 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
- 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 description 2
- 206010002556 Ankylosing Spondylitis Diseases 0.000 description 2
- 208000011231 Crohn disease Diseases 0.000 description 2
- 208000022559 Inflammatory bowel disease Diseases 0.000 description 2
- 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 description 2
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 2
- 210000003719 b-lymphocyte Anatomy 0.000 description 2
- 210000001198 duodenum Anatomy 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 210000003979 eosinophil Anatomy 0.000 description 2
- 210000001035 gastrointestinal tract Anatomy 0.000 description 2
- 230000002401 inhibitory effect Effects 0.000 description 2
- 210000004185 liver Anatomy 0.000 description 2
- 108010021753 peptide-Gly-Leu-amide Proteins 0.000 description 2
- 239000000546 pharmaceutical excipient Substances 0.000 description 2
- 229940124531 pharmaceutical excipient Drugs 0.000 description 2
- 210000003240 portal vein Anatomy 0.000 description 2
- 206010039073 rheumatoid arthritis Diseases 0.000 description 2
- 210000005166 vasculature Anatomy 0.000 description 2
- 102000019034 Chemokines Human genes 0.000 description 1
- 108010012236 Chemokines Proteins 0.000 description 1
- 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 description 1
- 239000011230 binding agent Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 239000007884 disintegrant Substances 0.000 description 1
- 238000013265 extended release Methods 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 230000005847 immunogenicity Effects 0.000 description 1
- 229960005435 ixekizumab Drugs 0.000 description 1
- 210000001630 jejunum Anatomy 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 239000008188 pellet Substances 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 230000002335 preservative effect Effects 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 230000009747 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 (enExample) | 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 (enExample) |
| JP (2) | JP7185401B2 (enExample) |
| CN (1) | CN107835682A (enExample) |
| AU (2) | AU2016261599B2 (enExample) |
| CA (1) | CA2984422C (enExample) |
| WO (1) | WO2016183040A1 (enExample) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8721620B2 (en) | 2009-12-24 | 2014-05-13 | Rani Therapeutics, Llc | Swallowable drug delivery device and methods of drug delivery |
| US8734429B2 (en) | 2010-12-23 | 2014-05-27 | Rani Therapeutics, Llc | Device, system and methods for the oral delivery of therapeutic compounds |
| 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 |
| 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 |
| 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 |
| AU2016320867B2 (en) * | 2015-09-08 | 2023-03-30 | Rani Therapeutics, Llc | PCSK9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device |
| US20200315540A1 (en) * | 2016-12-14 | 2020-10-08 | Progenity, Inc. | Treatment of a disease of the gastrointestinal tract with an il-1 inhibitor |
| US20200206132A1 (en) * | 2018-12-31 | 2020-07-02 | Incube Labs, Llc | Therapeutic agent preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device |
| WO2022026267A2 (en) * | 2020-07-30 | 2022-02-03 | Verily Life Sciences Llc | Pill with needle delivery system having outwardly expanding mechanical actuation |
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 |
| EP2081555A2 (en) * | 2006-09-12 | 2009-07-29 | 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 |
| CN102905753B (zh) | 2009-12-24 | 2016-06-29 | 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 |
| US8524215B2 (en) * | 2010-08-02 | 2013-09-03 | Janssen Biotech, Inc. | Absorbable PEG-based hydrogels |
| 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 |
| US9149617B2 (en) * | 2010-12-23 | 2015-10-06 | Rani Therapeutics, Llc | Device, system and methods for the oral delivery of therapeutic compounds |
| CN103987422B (zh) | 2011-06-29 | 2017-02-15 | 拉尼医疗有限公司 | 用于治疗化合物的口服递送的装置、系统和方法 |
| ES2773115T3 (es) * | 2011-06-29 | 2020-07-09 | Rani Therapeutics Llc | Preparados de agentes terapéuticos para la administración hacia el interior de una luz del tubo intestinal utilizando un dispositivo tragable para la administración de fármacos |
| US20150239970A1 (en) * | 2012-10-25 | 2015-08-27 | Medimmune, Llc | Stable, Low Viscosity Antibody Formulation |
| 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 |
| AU2016257813B2 (en) * | 2015-05-01 | 2021-05-13 | Rani Therapeutics, Llc | Pharmaceutical compositions and methods for fabrication of solid masses comprising polypeptides and/or proteins |
-
2016
- 2016-05-09 EP EP16793347.2A patent/EP3294273A4/en not_active Withdrawn
- 2016-05-09 AU AU2016261599A patent/AU2016261599B2/en active Active
- 2016-05-09 WO PCT/US2016/031548 patent/WO2016183040A1/en not_active Ceased
- 2016-05-09 CA CA2984422A patent/CA2984422C/en active Active
- 2016-05-09 JP JP2017557954A patent/JP7185401B2/ja active Active
- 2016-05-09 CN CN201680040187.5A patent/CN107835682A/zh active Pending
-
2020
- 2020-11-27 JP JP2020196688A patent/JP7232805B2/ja active Active
-
2021
- 2021-11-22 AU AU2021269453A patent/AU2021269453B2/en not_active Expired - Fee Related
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