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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Japan
Prior art keywords
hae
composition
antibody
treatment period
prior
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JP2021510984A
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Japanese (ja)
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JP2021535161A (en
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Priority claimed from PCT/US2019/048961 external-priority patent/WO2020047352A1/en
Publication of JP2021535161A publication Critical patent/JP2021535161A/en
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Claims (14)

遺伝性血管浮腫(HAE)発作を処置するかHAE発作率を減少させる方における使用のための組成物であって、
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投与され;
前記ヒト対象、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
(ii)18歳未満又は40~65歳であ
(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
(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、2~3回又は以上、HAE発作を起こしたことがあ;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 .
遺伝性血管浮腫(HAE)発作を処置するかHAE発作率を減少させる方における使用のための組成物であって、
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
(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、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 .
前記抗体が、
(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.
前記組成物が、薬学的に許容可能な担体を含む医薬組成物製剤化されており、
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~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 .
前記組成物は下投与される、請求項1~の何れか1項に記載の組成物A composition according to any preceding claim, wherein said composition is administered subcutaneously . (i)前記ヒト対象がI型HAE又はII型HAEを有する
(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~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 .
(i)前記事前HAE処置が、C1-インヒビター、血漿カリクレイン阻害剤、ブラジキニン受容体アンタゴニスト、アンドロゲン、抗線維素溶解薬又はそれらの組み合わせを含む
(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 .
前記漸減期間が約2~4週間である、請求項に記載の組成物8. The composition of claim 7 , wherein said tapering period is about 2-4 weeks. 前記1回以上の事前HAE処置が、前記抗体の最初の投与の又は前記抗体の最初の投与後3週間以内の何れかに終了する、請求項6、7または8の何れか1項に記載の組成物9. Any one of claims 6, 7 or 8 , wherein said one or more prior HAE treatments are terminated either prior to the first administration of said antibody or within 3 weeks after said first administration of said antibody. The composition according to . 前記ヒト対象が事前HAE処置を受けておらず、
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~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 .
(i)前記ヒト対象が、前記第1の処置期間の最初の投与の前の4週間で少なくとも1回のHAE発作又は前記第1の処置期間の最初の投与の前の8週間で少なくとも2回のHAE発作を起こしたことがある;及び/又は
(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 .
(i)前記第2の処置期間の最初の投与が、前記第1の処置期間の最後の投与から約2週間である;及び/又は
(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 .
前記ヒト対象が、前記第1の処置期間の前に、前記第1の処置期間中に、及び/又は前記第2の処置期間中に、HAEに対する長期予防、又はアンジオテンシン変換酵素(ACE)阻害剤、エストロゲン含有薬物療法若しくはアンドロゲンを含むHAE処置を受けていない、請求項1~12の何れか1項に記載の組成物The human subject is administered long-term prophylaxis against HAE or an angiotensin-converting enzyme (ACE) inhibitor prior to the first treatment period, during the first treatment period, and/or during the second treatment period 13. The composition of any one of claims 1-12 , wherein the composition is free of HAE treatment including, estrogen-containing medications or androgens. 前記方法が、
(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 .
JP2021510984A 2018-08-30 2019-08-30 Plasma kallikrein inhibitor and its use for treating hereditary angioedema attacks Pending JP2021535161A (en)

Applications Claiming Priority (5)

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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

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JP2021535161A JP2021535161A (en) 2021-12-16
JPWO2020047352A5 true JPWO2020047352A5 (en) 2022-09-05

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EP (1) EP3843840A1 (en)
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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)
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