JP2008539713A5 - - Google Patents
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- JP2008539713A5 JP2008539713A5 JP2008509505A JP2008509505A JP2008539713A5 JP 2008539713 A5 JP2008539713 A5 JP 2008539713A5 JP 2008509505 A JP2008509505 A JP 2008509505A JP 2008509505 A JP2008509505 A JP 2008509505A JP 2008539713 A5 JP2008539713 A5 JP 2008539713A5
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Description
さらなる態様においては、本発明は、腸機能の障害をもつ新生児、骨粗しょう症及びＤＰＰ−ＩＶ（ジペプチジルペプチダーゼ−ＩＶ）媒介症状の治療の如き、胃及び腸関連障害の治療及び／又は予防のための医薬の製造のための、ＧＬＰ−２アナログ又はその塩又は誘導体の使用を提供する。一例を挙げると、かかる胃及び腸関連障害は、潰瘍、胃炎、消化障害、吸収不良症候群、短腸症候群、盲管症候群、炎症性腸疾患、セリアック病（例えば、グルテン性腸症又は小児脂肪便症から発生するもの）、熱帯性スプルー、低ガンマグロブリン血スプルー、腸炎、限局性腸炎（クローン病）、潰瘍性大腸炎、下痢が付随する過敏性腸症候群、小腸損傷又は短腸症候群を含む。
Claims (30)
- 下記一般式：
Ｒ1−Ｚ1−Ｈｉｓ−Ｇｌｙ−Ｘ３−Ｇｌｙ−Ｘ５−Ｐｈｅ−Ｘ７−Ｓｅｒ−Ｇｌｕ−Ｘ１０−Ｘ１１−Ｔｈｒ−Ｉｌｅ−Ｌｅｕ−Ａｓｐ−Ｘ１６−Ｌｅｕ−Ａｌａ−Ａｌａ−Ａｒｇ−Ａｓｐ−Ｐｈｅ−Ｉｌｅ−Ｘ２４−Ｔｒｐ−Ｌｅｕ−Ｉｌｅ−Ｘ２８−Ｔｈｒ−Ｌｙｓ−Ｘ３１−Ｘ３２−Ｘ３３−Ｚ2−Ｒ2
｛式中、
Ｒ1は水素、Ｃ1-4アルキル、アセチル、ホルミル、ベンゾイル又はトリフルオロアセチルであり、
Ｘ３はＧｌｕ又はＡｓｐであり、
Ｘ５はＳｅｒ又はＴｈｒであり、
Ｘ７はＳｅｒ又はＴｈｒであり、
Ｘ１０はＭｅｔ、Ｌｅｕ、Ｎｌｅ、Ｖａｌ、Ｉｌｅ、Ａｓｎ、Ｇｌｕ、Ｇｌｎ、Ｔｙｒ、Ｐｈｅ、Ｔｒｐ、Ａｌａ、Ｓｅｒ、Ｇｌｙ、Ｍｅｔ（Ｏ）又はＭｅｔ（Ｏ） ２ であり、
Ｘ１１はＡｓｎ、Ａｌａ、Ｌｙｓ又はＳｅｒであり、
Ｘ１６はＡｓｎ又はＡｌａであり、
Ｘ２４はＡｓｎ又はＡｌａであり、
Ｘ２８はＧｌｎ又はＡｌａであり、
Ｘ３１はＩｌｅであるか又は欠失しており、
Ｘ３２はＴｈｒであるか又は欠失しており、
Ｘ３３はＡｓｐであるか又は欠失しており、
Ｒ2はＮＨ2又はＯＨであり、
Ｚ1及びＺ2は、独立して、Ａｌａ、Ｌｅｕ、Ｓｅｒ、Ｔｈｒ、Ｔｙｒ、Ａｓｎ、Ｇｌｎ、Ａｓｐ、Ｇｌｕ、Ｌｙｓ、Ａｒｇ、Ｈｉｓ、Ｍｅｔ又はＯｒｎから成る群から選択された３〜２０個のアミノ酸単位のペプチド配列であるか又は不在である。｝により表わされ、かつ、インビボでの腸質量の増加をひき起こすという生物活性を有するグルカゴン様ペプチド２（ＧＬＰ−２）アナログ又は医薬として許容されるその塩。 - 位置Ｘ１６、Ｘ２４及びＸ２８の内の１以上で、野生型ＧＬＰ−２配列に対しての置換、及び任意的に位置Ｘ３、Ｘ５、Ｘ７、Ｘ１０、及びＸ１１の内の１以上で、野生型ＧＬＰ−２配列に対しての置換をさらに含む、請求項１又は２に記載のＧＬＰ−２アナログ。
- 位置Ｘ１０での前記置換がＬｅｕ、Ｎｌｅ、Ｍｅｔ（Ｏ）又はＭｅｔ（Ｏ）2である、請求項２に記載のＧＬＰ−２アナログ。
- 位置Ｘ１１での前記置換がＡｌａ、Ｓｅｒ又はＬｙｓである、請求項２に記載のＧＬＰ−２アナログ。
- 以下の置換群：
Ａｌａ１６；
Ａｌａ２４；
Ａｌａ２８；
Ａｌａ１６、Ａｌａ２４；
Ａｌａ１６、Ａｌａ２８；
Ａｌａ２４、Ａｌａ２８；
Ａｌａ１６、Ａｌａ２４、Ａｌａ２８；
の内の１以上を含む、請求項２に記載のＧＬＰ−２アナログ。 - 以下の置換群：
Ｇｌｕ３、Ｔｈｒ５、Ｌｅｕ１０、Ｌｙｓ１１、Ａｌａ１６、２４、２８；
Ｇｌｕ３、Ｔｈｒ５、Ｓｅｒ１１、Ｌｅｕ１０、Ａｌａ１６、２４、２８；
Ｇｌｕ３、Ｌｅｕ１０、Ｓｅｒ１１、Ａｌａ１６、２４、２８；
Ｇｌｕ３、Ｔｈｒ５、Ｌｅｕ１０、Ａｌａ１１、１６、２４、２８；
Ｇｌｕ３、Ｌｅｕ１０、Ａｌａ１１、１６、２４、２８；
Ｔｈｒ７、Ｌｅｕ１０、Ｓｅｒ１１、Ａｌａ２４；
Ｔｈｒ７、Ｌｅｕ１０、Ａｌａ１１、２４；
Ｔｈｒ７、Ｌｅｕ１０、Ｌｙｓ１１、Ａｌａ２４；
Ｌｅｕ１０、Ａｌａ１１、２４；
Ｌｅｕ１０、Ｓｅｒ１１、Ａｌａ２４；
の内の１以上、又は位置Ｘ３１〜Ｘ３３の内の１以上での欠失を含む、請求項２に記載のＧＬＰ−２アナログ。 - 位置Ｘ３、及び／又はＸ２４で、野生型ＧＬＰ−２に対しての置換を含む、請求項１〜６のいずれか１項に記載のＧＬＰ−２アナログ。
- １８４６ Ｈ−ＨＧＥＧＳＦＳＳＥＬＳＴＩＬＤＡＬＡＡＲＤＦＩＡＷＬＩＡＴＫＩＴＤＫＫＫＫＫＫ−ＮＨ2；
である請求項１に記載のＧＬＰ−２アナログ又は医薬として許容されるその塩。 - １８４８ Ｈ−ＨＧＥＧＴＦＳＳＥＬＡＴＩＬＤＡＬＡＡＲＤＦＩＡＷＬＩＡＴＫＩＴＤＫＫＫＫＫＫ−ＮＨ2；
である請求項１に記載のＧＬＰ−２アナログ又は医薬として許容されるその塩。 - １８１８ Ｈ−ＨＧＤＧＳＦＳＳＥＬＡＴＩＬＤＮＬＡＡＲＤＦＩＡＷＬＩＱＴＫＫＫＫＫＫ−ＮＨ 2 ；
１８２０ Ｈ−ＨＧＤＧＳＦＴＳＥＬＡＴＩＬＤＮＬＡＡＲＤＦＩＡＷＬＩＱＴＫＫＫＫＫＫ−ＮＨ 2 ；
１８２３ Ｈ−ＨＧＤＧＳＦＴＳＥＬＫＴＩＬＤＮＬＡＡＲＤＦＩＡＷＬＩＱＴＫＫＫＫＫＫ−ＮＨ 2 ；
１８２５ Ｈ−ＨＧＤＧＳＦＳＳＥＬＡＴＩＬＤＮＬＡＡＲＤＦＩＡＷＬＩＱＴＫ−ＮＨ 2 ；
１８２８ Ｈ−ＨＧＤＧＳＦＴＳＥＬＳＴＩＬＤＮＬＡＡＲＤＦＩＡＷＬＩＱＴＫＫＫＫＫＫ−ＮＨ 2 ；
１８２９ Ｈ−ＨＧＤＧＳＦＳＳＥＬＳＴＩＬＤＮＬＡＡＲＤＦＩＡＷＬＩＱＴＫＫＫＫＫＫ−ＮＨ 2 ；
１８３２ Ｈ−ＨＧＤＧＳＦＴＳＥＬＳＴＩＬＤＮＬＡＡＲＤＦＩＡＷＬＩＱＴＫ−ＮＨ 2 ；
１８３３ Ｈ−ＨＧＤＧＳＦＳＳＥＬＳＴＩＬＤＮＬＡＡＲＤＦＩＡＷＬＩＱＴＫ−ＮＨ 2 ；
１８３４ Ｈ−ＨＧＤＧＳＦＴＳＥＬＡＴＩＬＤＮＬＡＡＲＤＦＩＡＷＬＩＱＴＫ−ＮＨ2；
１８４２ Ｈ−ＨＧＤＧＳＦＴＳＥＬＫＴＩＬＤＮＬＡＡＲＤＦＩＡＷＬＩＱＴＫ−ＮＨ 2 ；
１８４４ Ｈ−ＨＧＥＧＴＦＳＳＥＬＳＴＩＬＤＡＬＡＡＲＤＦＩＡＷＬＩＡＴＫＩＴＤＫＫＫＫＫＫ−ＮＨ2；
１８４９ Ｈ−ＨＧＥＧＳＦＳＳＥＬＡＴＩＬＤＡＬＡＡＲＤＦＩＡＷＬＩＡＴＫＩＴＤＫＫＫＫＫＫ−ＮＨ2；
１８５２ Ｈ−ＨＧＥＧＴＦＳＳＥＬＫＴＩＬＤＡＬＡＡＲＤＦＩＡＷＬＩＡＴＫＩＴＤＫＫＫＫＫＫ−ＮＨ2；
１８５３ Ｈ−ＨＧＥＧＴＦＳＳＥＬＳＴＩＬＤＡＬＡＡＲＤＦＩＡＷＬＩＡＴＫＩＴＤ−ＮＨ 2 ；
１８５５ Ｈ−ＨＧＥＧＳＦＳＳＥＬＳＴＩＬＤＡＬＡＡＲＤＦＩＡＷＬＩＡＴＫＩＴＤ−ＮＨ2；
１８５７ Ｈ−ＨＧＥＧＴＦＳＳＥＬＡＴＩＬＤＡＬＡＡＲＤＦＩＡＷＬＩＡＴＫＩＴＤ−ＮＨ2；
１８５８ Ｈ−ＨＧＥＧＳＦＳＳＥＬＡＴＩＬＤＡＬＡＡＲＤＦＩＡＷＬＩＡＴＫＩＴＤ−ＮＨ2；
１８６１ Ｈ−ＨＧＥＧＴＦＳＳＥＬＫＴＩＬＤＡＬＡＡＲＤＦＩＡＷＬＩＡＴＫＩＴＤ−ＮＨ 2 ；又は
である請求項１に記載のＧＬＰ−２アナログ又は医薬として許容されるその塩。 - 治療法に使用するための、請求項１〜１０のいずれか１項に記載のＧＬＰ−２アナログ。
- 担体と混和した状態の、請求項１〜１１のいずれか１項に記載のＧＬＰ−２アナログ又はその塩を含む医薬組成物。
- 前記ＧＬＰ−２アナログは、医薬として許容される酸付加塩である、請求項１２に記載の医薬組成物。
- 注射又は輸液による投与に適した液体として処方されるか又は前記ＧＬＰ−２アナログの徐放をひき起こすように処方されている、請求項１２又は１３に記載の医薬組成物。
- 胃及び腸関連の障害の治療及び／又は予防のための医薬の製造のための、請求項１〜１０のいずれか１項に記載のＧＬＰ−２アナログの使用。
- 前記胃及び腸関連の障害が、潰瘍、胃炎、消化障害、吸収不良症候群、短腸症候群、盲管症候群、炎症性腸疾患、セリアック病、熱帯性スプルー、低ガンマグロブリン血スプルー、腸炎、限局性腸炎（クローン病）、潰瘍性大腸炎、下痢が付随する過敏性腸症候群、小腸損傷又は短腸症候群である、請求項１５に記載の使用。
- 前記胃及び腸関連障害が、放射線腸炎、感染性又は感染後腸炎、又は毒性その他の化学療法薬に起因する小腸損傷である、請求項１５に記載の使用。
- 化学療法又は放射線治療の副作用の治療及び／又は予防のための医薬の製造のための請求項１〜１０のいずれか１項に記載のＧＬＰ−２アナログの使用。
- 前記副作用が、化学療法に因る下痢、腹部疝痛、又は嘔吐、あるいは化学慮法又は放射線療法から生じる腸上皮の構造的及び機能的損傷である、請求項１８に記載の使用。
- 新生児における腸機能障害、骨粗しょう症又はＤＰＰ−ＩＶ（ジペプチジルペプチダーゼ−ＩＶ）媒介型症状の治療用の医薬の製造のための、請求項１〜１０のいずれか１項に記載のＧＬＰ−２アナログの使用。
- 栄養失調症が関与する症状の治療及び／又は予防のための医薬の製造のための請求項１〜１０のいずれか１項に記載のＧＬＰ−２アナログの使用。
- 前記栄養失調症が関与する症状は、悪液質又は拒食症である、請求項２１に記載の使用。
- 請求項１〜１０のいずれか１項に記載のＧＬＰ−２アナログをコードする核酸配列を含む核酸分子。
- 請求項２３に記載の核酸配列をその発現を導くべく制御配列とともに含む発現ベクター。
- 請求項２４に記載の発現ベクターで形質転換された宿主細胞。
- ＧＬＰ−２アナログを発現させるのに適した条件下で、請求項２５に記載の宿主細胞を培養する工程、及びそうして製造されたＧＬＰ−２アナログを精製する工程を含む、請求項１〜１０のいずれか１項に記載のＧＬＰ−２アナログの製造方法。
- 治療に使用するための、請求項２３に記載の核酸分子、請求項２４に記載の発現ベクター又は請求項２５に記載の宿主細胞。
- 胃及び腸関連の障害の治療及び／又は予防、又は化学療法又は放射線治療の副作用の治療及び／又は予防、又は新生児における腸機能障害、骨粗しょう症又はＤＰＰ−ＩＶ（ジペプチジルペプチダーゼ−ＩＶ）媒介型症状の治療のための医薬の製造のための、請求項２３に記載の核酸分子、請求項２４に記載の発現ベクター又は請求項２５に記載の宿主細胞の使用。
- 各々任意的に医薬として許容される担体とともに、癌化学療法薬、及び請求項１〜１０のいずれか１項に記載のＧＬＰ−２アナログ、請求項２３に記載の核酸分子、請求項２４に記載の発現ベクター又は請求項２５に記載の宿主細胞を含む、治療用キット。
- 医薬として許容される担体とともに、癌化学療法薬、及び請求項１〜１０のいずれか１項に記載のＧＬＰ−２アナログ、請求項２３に記載の核酸分子、請求項２４に記載の発現ベクター又は請求項２５に記載の宿主細胞を含む医薬組成物。
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| EP1542712A2 (en) | 2001-06-01 | 2005-06-22 | Eli Lilly And Company | Glp-1 formulations with protracted time action |
| US7411039B2 (en) * | 2002-10-14 | 2008-08-12 | Novo Nordisk A/S | GLP-2 compounds, formulations, and uses thereof |
| JP2007525425A (ja) * | 2003-03-24 | 2007-09-06 | ノボ ノルディスク アクティーゼルスカブ | Ｇｌｐ−２誘導体 |
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| NZ591179A (en) | 2005-05-04 | 2012-06-29 | Zealand Pharma As | Glucagon-like-peptide-2 (glp-2) analogues |
| NZ576260A (en) | 2006-11-08 | 2012-04-27 | Zealand Pharma As | GLUCAGON-LIKE-PEPTIDE-2 (GLP-2) ANALOGUES comprising one of more substitutions as compared to h[Gly2]GLP-2 |
| CA2747109A1 (en) | 2008-12-15 | 2010-06-24 | Zealand Pharma A/S | Glucagon analogues |
| UY33462A (es) | 2010-06-23 | 2012-01-31 | Zealand Pharma As | Analogos de glucagon |
| KR102011924B1 (ko) | 2011-05-18 | 2019-08-21 | 메더리스 다이어비티즈, 엘엘씨 | 인슐린 저항성에 대한 개선된 펩티드 제약 |
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