JPWO2020047352A5 - - Google Patents
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- JPWO2020047352A5 JPWO2020047352A5 JP2021510984A JP2021510984A JPWO2020047352A5 JP WO2020047352 A5 JPWO2020047352 A5 JP WO2020047352A5 JP 2021510984 A JP2021510984 A JP 2021510984A JP 2021510984 A JP2021510984 A JP 2021510984A JP WO2020047352 A5 JPWO2020047352 A5 JP WO2020047352A5
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- hae
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- 206010019860 Hereditary angioedema Diseases 0.000 claims 26
- 239000000203 mixture Substances 0.000 claims 25
- 102000004965 antibodies Human genes 0.000 claims 16
- 108090001123 antibodies Proteins 0.000 claims 16
- 230000035492 administration Effects 0.000 claims 11
- 108010047041 Complementarity Determining Regions Proteins 0.000 claims 6
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 6
- FAPWRFPIFSIZLT-UHFFFAOYSA-M sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 4
- 108010005563 Complement C1 Inhibitor Protein Proteins 0.000 claims 3
- 102100009270 SERPING1 Human genes 0.000 claims 3
- 229940009550 C1 esterase inhibitor Drugs 0.000 claims 2
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 2
- 102000004270 Peptidyl-Dipeptidase A Human genes 0.000 claims 2
- 108090000882 Peptidyl-Dipeptidase A Proteins 0.000 claims 2
- 229940068968 Polysorbate 80 Drugs 0.000 claims 2
- 239000003098 androgen Substances 0.000 claims 2
- 239000003937 drug carrier Substances 0.000 claims 2
- 239000003112 inhibitor Substances 0.000 claims 2
- 230000002401 inhibitory effect Effects 0.000 claims 2
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 2
- 229920000053 polysorbate 80 Polymers 0.000 claims 2
- 239000011780 sodium chloride Substances 0.000 claims 2
- 239000001488 sodium phosphate Substances 0.000 claims 2
- 229910000162 sodium phosphate Inorganic materials 0.000 claims 2
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims 2
- GYDJEQRTZSCIOI-LJGSYFOKSA-N (1r,4r)-4-(aminomethyl)cyclohexane-1-carboxylic acid Chemical compound NC[C@H]1CC[C@H](C(O)=O)CC1 GYDJEQRTZSCIOI-LJGSYFOKSA-N 0.000 claims 1
- 229940030486 ANDROGENS Drugs 0.000 claims 1
- POZRVZJJTULAOH-LHZXLZLDSA-N Danazol Chemical compound C1[C@]2(C)[C@H]3CC[C@](C)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=CC2=C1C=NO2 POZRVZJJTULAOH-LHZXLZLDSA-N 0.000 claims 1
- VBGWSQKGUZHFPS-VGMMZINCSA-N Kalbitor Chemical compound C([C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H](C(N[C@@H](CC=2C=CC=CC=2)C(=O)N[C@H](C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H]2C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC=3C=CC=CC=3)C(=O)N[C@H](C(=O)N[C@@H](CC=3C=CC(O)=CC=3)C(=O)NCC(=O)NCC(=O)N[C@H]3CSSC[C@H](NC(=O)[C@@H]4CCCN4C(=O)CNC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](C)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CC=4C=CC=CC=4)NC(=O)[C@H](C)NC(=O)[C@@H](NC(=O)[C@H](CC=4C=CC=CC=4)NC(=O)[C@H](CO)NC(=O)[C@H](CC=4NC=NC=4)NC(=O)[C@H](CCSC)NC(=O)[C@H](C)NC(=O)[C@@H](N)CCC(O)=O)CSSC[C@H](NC(=O)[C@H](CCSC)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CCCCN)NC(=O)[C@@H](NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CC=4C=CC=CC=4)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)CNC(=O)[C@H](CCC(O)=O)NC3=O)CSSC2)C(=O)N[C@@H]([C@H](C)O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC(O)=O)C(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](C)C(=O)N[C@@H](C)C(=O)N[C@@H](CC=2NC=NC=2)C(=O)N2CCC[C@H]2C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC=2C3=CC=CC=C3NC=2)C(=O)N[C@@H](CC=2C=CC=CC=2)C(=O)N1)[C@@H](C)CC)[C@H](C)O)=O)[C@@H](C)CC)C1=CC=CC=C1 VBGWSQKGUZHFPS-VGMMZINCSA-N 0.000 claims 1
- 102000003827 Plasma kallikrein Human genes 0.000 claims 1
- 108090000113 Plasma kallikrein Proteins 0.000 claims 1
- 239000000504 antifibrinolytic agent Substances 0.000 claims 1
- 239000000427 antigen Substances 0.000 claims 1
- 102000038129 antigens Human genes 0.000 claims 1
- 108091007172 antigens Proteins 0.000 claims 1
- 239000003152 bradykinin antagonist Substances 0.000 claims 1
- 229960000766 danazol Drugs 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 229960001174 ecallantide Drugs 0.000 claims 1
- 108010011867 ecallantide Proteins 0.000 claims 1
- 239000000262 estrogen Substances 0.000 claims 1
- 229960001062 icatibant Drugs 0.000 claims 1
- RNFSRGBKGWQTPO-SKXRKSCCSA-N icatibant Chemical compound NC(=N)NCCC[C@@H](N)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N1CCC[C@H]1C(=O)N1[C@H](C(=O)NCC(=O)N[C@@H](CC=2SC=CC=2)C(=O)N[C@@H](CO)C(=O)N2[C@H](CC3=CC=CC=C3C2)C(=O)N2[C@@H](C[C@@H]3CCCC[C@@H]32)C(=O)N[C@@H](CCCNC(N)=N)C(N)=O)C[C@@H](O)C1 RNFSRGBKGWQTPO-SKXRKSCCSA-N 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 230000000069 prophylaxis Effects 0.000 claims 1
- 229960000401 tranexamic acid Drugs 0.000 claims 1
Claims (14)
前記組成物は、配列番号5~7として示される重鎖相補性決定領域(CDR)と配列番号8~10として示される軽鎖CDRとを含む抗体を含み、
前記方法は、それを必要とするヒト対象に第1の処置期間において前記組成物を投与することを含み;
前記第1の処置期間において、前記抗体は、2週間ごとに約300mgで前記ヒト対象に複数回投与され;
前記ヒト対象は、HAEに罹患しているか、罹患している疑いがあるか又はHAEのリスクがあり、前記ヒト対象は、
(i)女性である;
(ii)18歳未満又は40~65歳である;
(iii)少なくとも1回、以前に喉頭HAE発作を経験したことがある;
(iv)前記第1の処置期間の最初の投与の前の4週間で、1~2回、2~3回、又は4回以上、HAE発作を起こしたことがある;及び/又は
(v)前記第1の処置期間の前にC1-インヒビターによる処置を受けたことがある、
組成物。 1. A composition for use in a method of treating hereditary angioedema (HAE) attacks or reducing HAE attack rates comprising:
said composition comprising an antibody comprising heavy chain complementarity determining regions (CDRs) set forth as SEQ ID NOs: 5-7 and light chain CDRs set forth as SEQ ID NOs: 8-10;
said method comprising administering said composition to a human subject in need thereof in a first treatment period;
in the first treatment period, the antibody is administered to the human subject multiple times at about 300 mg every two weeks ;
said human subject having , suspected of having, or at risk of HAE , said human subject comprising:
(i) is female;
(ii) is under the age of 18 or between the ages of 40-65 ;
(iii) have had at least one previous laryngeal HAE attack;
(iv) have had 1-2 , 2-3 , or 4 or more HAE attacks in the 4 weeks prior to the first dose of said first treatment period; and/or (v ) had received treatment with a C1-inhibitor prior to said first treatment period;
composition .
前記組成物は、配列番号5~7として示される重鎖相補性決定領域(CDR)と配列番号8~10として示される軽鎖CDRとを含む抗体を含み、
前記方法は、それを必要とするヒト対象に前記組成物を投与することを含み、
前記ヒト対象は、
(i)12~18歳の青年期であり;及び/又は
(ii)前記抗体の最初の投与の前の4週間で2~3回、又は4回以上、HAE発作を起こしたことがあり、
前記抗体は、4週間ごとに約150mgで、4週間ごとに約300mgで、又は2週間ごとに約300mgで、前記ヒト対象に投与される、
組成物。 1. A composition for use in a method of treating hereditary angioedema (HAE) attacks or reducing HAE attack rates comprising:
said composition comprising an antibody comprising heavy chain complementarity determining regions (CDRs) set forth as SEQ ID NOs: 5-7 and light chain CDRs set forth as SEQ ID NOs: 8-10;
said method comprising administering said composition to a human subject in need thereof,
The human subject is
(i) is an adolescent between the ages of 12 and 18; and/or (ii) has had 2-3 or more than 4 HAE attacks in the 4 weeks prior to the first administration of said antibody,
said antibody is administered to said human subject at about 150 mg every 4 weeks, at about 300 mg every 4 weeks , or at about 300 mg every 2 weeks;
composition .
(i)全長抗体又はその抗原結合断片である;
(ii)配列番号3により示される重鎖可変領域及び/又は配列番号4により示される軽鎖可変領域を含む;及び/又は
(iii)配列番号1により示される重鎖及び配列番号2により示される軽鎖を含む;
請求項1又は請求項2に記載の組成物。 the antibody
(i) a full-length antibody or an antigen-binding fragment thereof ;
(ii) comprises a heavy chain variable region set forth by SEQ ID NO:3 and/or a light chain variable region set forth by SEQ ID NO:4; and/or
(iii) comprising a heavy chain represented by SEQ ID NO: 1 and a light chain represented by SEQ ID NO: 2;
3. A composition according to claim 1 or claim 2.
前記薬学的に許容可能な担体はリン酸ナトリウム、クエン酸、ヒスチジン、塩化ナトリウム及びポリソルベート80を含んでもよく、
前記リン酸ナトリウムは約30mMの濃度であってもよく、前記クエン酸は約19mMの濃度であってもよく、前記ヒスチジンは約50mMの濃度であってもよく、前記塩化ナトリウムは約90mMの濃度であってもよく、前記ポリソルベート80は約0.01%であってもよい、
請求項1~3の何れか1項に記載の組成物。 said composition being formulated into a pharmaceutical composition comprising a pharmaceutically acceptable carrier ;
The pharmaceutically acceptable carriers may include sodium phosphate, citric acid, histidine, sodium chloride and polysorbate 80;
The sodium phosphate may be at a concentration of about 30 mM, the citric acid may be at a concentration of about 19 mM, the histidine may be at a concentration of about 50 mM, and the sodium chloride may be at a concentration of about 90 mM. and the polysorbate 80 may be about 0.01% .
A composition according to any one of claims 1-3 .
(ii)前記ヒト対象が、前記第1の処置期間の前に1年あたり少なくとも2回HAE発作を経験したことがある;及び/又は
(iii)前記ヒト対象が、前記第1の処置期間の前に1回以上の事前HAE処置を受けたことがある;
請求項1~5の何れか1項に記載の組成物。 (i) the human subject has type I HAE or type II HAE ;
(ii) the human subject has experienced at least two HAE attacks per year prior to the first treatment period; and/or
(iii) said human subject has received one or more prior HAE treatments prior to said first treatment period;
A composition according to any one of claims 1-5 .
(ii)前記事前HAE処置が、C1-INH、エカランチド、イカチバント、ダナゾール、トラネキサム酸又はそれらの組み合わせを含む;及び/又は
(iii)前記方法が、前記1回以上の事前HAE処置の漸減期間を含む;
請求項6に記載の組成物。 (i) said prior HAE treatment comprises a C1-inhibitor, a plasma kallikrein inhibitor, a bradykinin receptor antagonist, an androgen, an antifibrinolytic agent, or a combination thereof ;
(ii) said prior HAE treatment comprises C1-INH, ecallantide, icatibant, danazol, tranexamic acid or a combination thereof; and/or
(iii) said method comprises a tapering period of said one or more prior HAE treatments;
A composition according to claim 6 .
前記ヒト対象は、前記抗体の最初の投与の前の少なくとも2週間に事前HAE処置を受けていなくてもよい、
請求項1~6の何れか1項に記載の組成物。 the human subject has not received prior HAE treatment;
said human subject may have had no prior HAE treatment for at least 2 weeks prior to the first administration of said antibody ;
A composition according to any one of claims 1-6 .
(ii)前記方法が、前記第1の処置期間の後の第2の処置期間に、前記抗体を前記対象に投与することをさらに含む;
請求項1~10の何れか1項に記載の組成物。 (i) the human subject has had at least one HAE attack in the four weeks prior to the first administration of the first treatment period or at least two in the eight weeks prior to the first administration of the first treatment period; have had an HAE attack ; and/or
(ii) the method further comprises administering the antibody to the subject during a second treatment period after the first treatment period;
A composition according to any one of claims 1-10 .
(ii)前記第2の処置期間が、約300mgでの前記抗体の1回以上の投与を含み、前記第2の処置期間は、2週間ごとに約300mgでの前記抗体の複数回投与を含んでもよい;
請求項11に記載の組成物。 (i) the first administration of said second treatment period is about two weeks after the last administration of said first treatment period ; and/or
(ii) said second treatment period comprises one or more administrations of said antibody at about 300 mg, said second treatment period comprising multiple administrations of said antibody at about 300 mg every two weeks; may be;
12. The composition of claim 11 .
(a)前記第1の処置期間後に、前記抗体を、それを必要とする前記ヒト対象に約300mgの用量で1回投与することと;
(b)前記対象が(a)の後にHAE発作を経験する場合、前記抗体を前記対象に約300mgの用量で1回以上さらに投与することと;
をさらに含み、
(i)段階(b)において、前記対象は、前記抗体を2週間ごとに約300mgの用量で複数回投与される;
(ii)段階(b)の最初の投与が前記HAE発作後1週間以内である;及び/又は
(iii)(a)の1回の投与と(b)の最初の投与が少なくとも10日間離される;
請求項1~13の何れか1項に記載の組成物。
said method comprising:
(a) after the first treatment period, administering the antibody to the human subject in need thereof once at a dose of about 300 mg ;
(b) if said subject experiences an HAE attack after (a), further administering said antibody to said subject one or more times in doses of about 300 mg ;
further comprising
(i) in step (b), said subject is administered said antibody at multiple doses of about 300 mg every two weeks;
(ii) the first administration of step (b) is within 1 week after said HAE attack; and/or
(iii) the one dose of (a) and the first dose of (b) are separated by at least 10 days;
A composition according to any one of claims 1-13 .
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201862725216P | 2018-08-30 | 2018-08-30 | |
US62/725,216 | 2018-08-30 | ||
US201962808612P | 2019-02-21 | 2019-02-21 | |
US62/808,612 | 2019-02-21 | ||
PCT/US2019/048961 WO2020047352A1 (en) | 2018-08-30 | 2019-08-30 | Plasma kallikrein inhibitors and uses thereof for treating hereditary angioedema attack |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2021535161A JP2021535161A (en) | 2021-12-16 |
JPWO2020047352A5 true JPWO2020047352A5 (en) | 2022-09-05 |
Family
ID=67953889
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2021510984A Pending JP2021535161A (en) | 2018-08-30 | 2019-08-30 | Plasma kallikrein inhibitor and its use for treating hereditary angioedema attacks |
Country Status (12)
Country | Link |
---|---|
US (2) | US20200109214A1 (en) |
EP (1) | EP3843840A1 (en) |
JP (1) | JP2021535161A (en) |
KR (1) | KR20210053928A (en) |
CN (1) | CN113056304A (en) |
AU (1) | AU2019328324A1 (en) |
BR (1) | BR112021003789A2 (en) |
CA (1) | CA3110689A1 (en) |
IL (1) | IL281063A (en) |
MA (1) | MA53490A (en) |
MX (1) | MX2021002349A (en) |
WO (1) | WO2020047352A1 (en) |
Families Citing this family (5)
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KR102107695B1 (en) | 2011-01-06 | 2020-05-07 | 다이액스 코포레이션 | Plasma kallikrein binding proteins |
WO2014152232A2 (en) | 2013-03-15 | 2014-09-25 | Dyax Corp. | Anti-plasma kallikrein antibodies |
BR112016022318A2 (en) | 2014-03-27 | 2017-10-31 | Dyax Corp | method, pharmaceutical composition for use in the treatment of retinal diseases and use of an antibody |
BR112018011622A2 (en) | 2015-12-11 | 2018-11-27 | Dyax Corp | method to treat hereditary angioedema attack (hae) or reduce hae attack rate |
WO2021146160A1 (en) * | 2020-01-13 | 2021-07-22 | Takeda Pharmaceutical Company Limited | Plasma kallikrein inhibitors and uses thereof for treating pediatric hereditary angioedema attack |
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KR102107695B1 (en) * | 2011-01-06 | 2020-05-07 | 다이액스 코포레이션 | Plasma kallikrein binding proteins |
WO2014152232A2 (en) * | 2013-03-15 | 2014-09-25 | Dyax Corp. | Anti-plasma kallikrein antibodies |
BR112016022318A2 (en) * | 2014-03-27 | 2017-10-31 | Dyax Corp | method, pharmaceutical composition for use in the treatment of retinal diseases and use of an antibody |
AU2016243160B2 (en) * | 2015-03-30 | 2022-02-24 | Takeda Pharmaceutical Company Limited | Plasma kallikrein inhibitors and uses thereof for preventing hereditary angioedema attack |
BR112018011622A2 (en) * | 2015-12-11 | 2018-11-27 | Dyax Corp | method to treat hereditary angioedema attack (hae) or reduce hae attack rate |
CN108368840B (en) * | 2015-12-18 | 2020-10-09 | 固瑞克明尼苏达有限公司 | Corrugated pipe mounting and retaining method |
-
2019
- 2019-08-30 AU AU2019328324A patent/AU2019328324A1/en active Pending
- 2019-08-30 BR BR112021003789-6A patent/BR112021003789A2/en unknown
- 2019-08-30 CN CN201980072190.9A patent/CN113056304A/en active Pending
- 2019-08-30 US US16/556,524 patent/US20200109214A1/en not_active Abandoned
- 2019-08-30 MX MX2021002349A patent/MX2021002349A/en unknown
- 2019-08-30 KR KR1020217009365A patent/KR20210053928A/en active Search and Examination
- 2019-08-30 WO PCT/US2019/048961 patent/WO2020047352A1/en unknown
- 2019-08-30 JP JP2021510984A patent/JP2021535161A/en active Pending
- 2019-08-30 MA MA053490A patent/MA53490A/en unknown
- 2019-08-30 EP EP19768977.1A patent/EP3843840A1/en active Pending
- 2019-08-30 CA CA3110689A patent/CA3110689A1/en active Pending
-
2021
- 2021-02-23 IL IL281063A patent/IL281063A/en unknown
-
2022
- 2022-05-16 US US17/745,770 patent/US20230104754A1/en active Pending
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