JP2015503628A - 肝疾患及び肝障害を治療するための組成物及び方法 - Google Patents
肝疾患及び肝障害を治療するための組成物及び方法 Download PDFInfo
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- JP2015503628A JP2015503628A JP2014552395A JP2014552395A JP2015503628A JP 2015503628 A JP2015503628 A JP 2015503628A JP 2014552395 A JP2014552395 A JP 2014552395A JP 2014552395 A JP2014552395 A JP 2014552395A JP 2015503628 A JP2015503628 A JP 2015503628A
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Abstract
Description
本願は、2012年1月16日に提出された米国特許仮出願第61/586,975号に基づくとともに、これに基づく優先権を主張するものであり、この仮出願の内容は、その全体が本明細書に組み込まれる。
該当なし
なし
下記の定義は、本発明の詳細な説明を当業者が理解するのを助ける目的で提供されている。
本開示の治療活性組成物は、天然の非合成生物活性物質、好ましくは、溶解産物などの形態の、1種以上のグラム陽性菌の1種以上の細胞壁画分と、プロモーターと、任意に応じて、治療を必要とする対象の粘膜壁に上記の組成物を吸収させるか、又はこの粘膜壁と相互作用させるように、放出制御成分を含む1種以上の他の添加剤とを含む。
本発明の治療組成物は、放出制御添加剤も含んでもよい。治療組成物に放出制御添加剤が存在すると、対象の粘膜に送達後、最初の1〜2分の間に治療組成物から放出される生物活性物質の「初期バースト」が実質的に軽減される。本明細書で使用する場合、「実質的に軽減される」という用語は、放出制御添加剤を含まない組成物と比べて、治療組成物から放出される生物活性物質が少なくとも15%減少することを意味する。放出制御添加剤は、放出制御添加剤を含まない治療組成物と比べて、本発明のポリマー組成物から放出される生物活性物質の初期バーストを約15%〜約70%、より好ましくは約30%〜約60%軽減するのが好ましい。
本発明の治療組成物は、例えば錠剤(例えばチュアブル錠、徐溶解錠、速溶解錠)、丸剤、カプセル剤、トローチ剤、キャンディ、ガム、散剤、溶剤、懸濁剤、乳剤、又はエアゾール剤など、固体、半固体、凍結乾燥粉末、又は液体の剤形の形態をとってよい。好ましくは、剤形はチューインガム、速溶解錠、キャンディ、又はトローチ剤である。
剤形がチューインガムであるときには、本発明の組成物は、グラム陽性菌に由来する活性治療剤又はその製薬学的に許容可能な塩と、プロモーターと、ガムベースのような担体と、二成分又は三成分緩衝系と、任意に応じて保護剤とを含む。このチューインガム組成物は、滑沢剤、湿潤剤、乳化剤、懸濁化剤、防腐剤、甘味剤、矯味矯臭剤、及び着色剤をさらに含んでもよい。典型的には、このチューインガム組成物は、(選択した形態がいかなるものであれ、その遊離塩基型により測定した場合)活性治療剤を約0.001重量%〜約10.0重量%、より典型的には約0.01%〜約5.0%、さらに典型的には約0.1%〜約3.0%含む。前記パーセンテージは、用いるグラム陽性菌系活性治療剤の具体的な供給源、最終製剤において所望される、活性治療剤の量、所望される、活性治療剤の具体的な放出速度に応じて変化することが当業者には分かる。本発明のチューインガム組成物の任意の緩衝系は、少なくとも約8.0超、好ましくは少なくとも約9.5、より好ましくは約9.9〜約11の範囲の最終唾液pHをもたらすことができる。本発明のチューインガム組成物は、典型的にはガムベースを約20重量%〜約95%重量、より典型的には約30%〜約85%、最も典型的にはガムベースを約50%〜約70%含む。
剤形が、溶解錠(すなわち崩壊錠)又はチュアブル錠などの錠剤であるときには、本発明の組成物は、本明細書に記載されているような、1種以上のグラム陽性菌に由来する治療剤又はその製薬学的に許容可能な塩と、プロモーターと、結合剤などの担体と、二成分緩衝系又は三成分緩衝系を含む緩衝系とを含む。錠剤組成物は、滑沢剤、湿潤剤、乳化剤、懸濁化剤、防腐剤、甘味剤、矯味矯臭剤、着色剤、及び崩壊剤をさらに含んでもよい。典型的には、本発明の錠剤組成物は、(選択した形態がいかなるものであれ、その遊離塩基型により測定した場合)活性治療剤を約0.001重量%〜約10.0重量%、より典型的には約1.0%〜約5.0%含む。前記パーセンテージは、用いる活性治療剤の具体的な供給源、最終製剤において所望される、活性治療剤の量、及び所望される、活性治療剤の具体的な放出速度に応じて変化することが当業者には分かる。本発明の錠剤組成物の緩衝系は、少なくとも約8.0超、好ましくは少なくとも約9.5、より好ましくは約pH9.9〜約pH11の範囲の最終唾液pHをもたらす。
剤形がトローチ剤又はキャンディであるときには、本発明の組成物は、グラム陽性菌由来の活性剤又はその製薬学的に許容可能な塩と、任意のプロモーターと、結合剤などの担体と、二成分緩衝系又は三成分緩衝系を含む緩衝系とを含み、トローチ剤又はキャンディ組成物は、滑沢剤、湿潤剤、乳化剤、懸濁化剤、防腐剤、甘味剤、矯味矯臭剤、着色剤、及び崩壊剤をさらに含んでもよい。トローチ剤及びキャンディの総括的議論は、例えば“Pharmaceutical Dosage Forms,Volume1:Tablets”[2nd Ed.,Marcel Dekker,Inc.,New York,N.Y.,pages75−418(1989)]に示されている。
本発明の組成物は、治療用途、例えば、A型肝炎、B型肝炎、及び/又はC型肝炎を含む(これらに限らない)肝疾患又は肝障害を治療する必要のある対象において、このような治療を行うのに有用である。本発明の方法は、様々な肝障害、具体的には、対象の補体系の副経路との関連性によって特徴付けられる肝障害の治療に有用である。したがって、本開示によれば、肝障害は、肝臓又は周囲の脈管系におけるいずれかの肝疾患又は肝障害である。例えば、本発明の方法及び組成物は、感染、医原性障害、遺伝性障害、自己免疫障害、胆汁うっ滞性症候群、サルコイドーシス、臓器移植、及び肝癌などに起因するものを含め、様々な肝障害の治療に有用である。
本開示の活性治療剤組成物は、自然免疫の補体系における副経路(AP)の活性化剤であると考えられる。いずれの特定の理論にも拘束されることを意図しないが、本開示の活性治療剤組成物は、副経路のカスケードを開始させてC3転換酵素の形成を促すことによって作用すると考えられる。続いて、この化合物、C3転換酵素が、補体のC3増幅ループを通じてAPを調節し、殺ウイルス作用(virocidal)などを示すことが知られているC5を形成させる。
実施例1:活性成分組成物の調製
本明細書に記載されているような例示的な製剤であって、治験及びさらにはスクリーニング試験などの細胞株試験に好適な製剤を調製するための活性成分
所定のTLR又はNLRを発現しているHEK293細胞でのNF−κBの活性化を評価することによって、TLR刺激を試験した。サンプルの活性は、7種類のヒトTLR、すなわちTLR2、3、4、5、7、8、及び9(Invivogen、カリフォルニア州サンディエゴ)と、2種類のヒトNLR(NOD1及びNOD2)で試験した。各リガンドは、TLR又はNLR細胞上で、ストック溶液の終濃度1/100にて試験し、下記のようなコントロールリガンドと比較した。この工程は、3連で行った。
Claims (20)
- 肝疾患又は肝障害を治療する方法であって、
前記治療を必要とする対象に、補体系経路をアップレギュレーション又はダウンレギュレーションできる少なくとも1種の治療活性物質を治療有効量投与することを含み、
前記治療活性物質が、1種以上の転換酵素の形成を増大させる方法。 - 前記少なくとも1種の治療活性物質が、ラクトバチルス属、ストレプトコッカス属、ビフィドバクテリウム属、バチルス属、又はそれらの生物学的に活性な断片若しくは変異体から選択したグラム陽性菌である、請求項1に記載の方法
- 前記グラム陽性菌を、バチルス・コアギュランス(ラクトバチルス・スポロジーンズ)、ストレプトコッカス・サーモフィルス、ビフィドバクテリウム・アニマリス(特にB.アニマリス・サブスピーシーズ・アニマリス)、ビフィドバクテリウム・インファンティス、ビフィドバクテリウム・ロンガム、ビフィドバクテリウム・ブレーベ、ラクトバチルス・アシドフィルス、ラクトバチルス・プランタラム、ラクトバチルス・カゼイ、ラクトバチルス・デルブルッキィー・サブスピーシーズ・ブルガリカス、ラクトコッカス・ラクティス、ラクトコッカス・ラクティス・サブスピーシーズ・ラクティス(ストレプトコッカス・ラクティス)、ストレプトコッカス・サーモフィルス、ビフィドバクテリウム・ラクチス、ビフィドバクテリウム・ブレーベ、ラクトバチルス・アシドフィルス、ラクトバチルス・プランタラム、ラクトバチルス・カゼイ、及びラクトバチルス・ヘルベティカス、並びにこれらの組み合わせからなる群から選択する、請求項2に記載の方法。
- アップレギュレーション又はダウンレギュレーションされる前記転換酵素がC3転換酵素又はC5転換酵素である、請求項1に記載の方法。
- 前記肝炎疾患がA型肝炎、B型肝炎、又はC型肝炎である、請求項1に記載の方法。
- 前記投与方法が、治療する対象の粘膜を通したものである、請求項1に記載の方法。
- 前記粘膜を、舌下粘膜、頬粘膜、及びこれらの組み合わせからなる群から選択する、請求項6に記載の方法。
- 対象におけるToll様受容体(TLR)誘発性炎症を軽減又は抑制する方法であって、
前記軽減又は抑制を必要とする対象に、
(a)グラム陽性菌由来の溶解産物若しくは細胞壁抽出物、又はその製薬学的に許容可能な塩と、
(b)プロモーターと、
(c)任意の担体と、
を含む組成物を有効量投与することを含み、
前記細胞壁溶解産物が、炎症性障害を治療するのに有効な量で存在し、
それにより、前記対象においてToll様受容体(TLR)誘発性炎症を軽減又は抑制する方法。 - 前記炎症がウイルスを原因とする、請求項8に記載の方法。
- 前記TLRが、TLR2、TLR3、TLR4、TLR5、TLR7、TLR8、及びTLR9のうちの1つ以上である、請求項9に記載の方法。
- 前記TLRがTLR2である、請求項10に記載の方法。
- 前記TLRがTLR4である、請求項10に記載の方法。
- 肝障害の治療を必要とする対象における肝障害を治療するための組成物であって、
(a)グラム陽性菌由来の溶解産物若しくは細胞壁抽出物、又はその製薬学的に許容可能な塩と、
(b)プロモーターと、
(c)任意の担体と、
を含み、
前記溶解産物又は細胞壁抽出物が、肝障害を治療するのに有効な量で存在する組成物。 - 前記グラム陽性菌が、バチルス・コアギュランス(ラクトバチルス・スポロジーンズ)、ストレプトコッカス・サーモフィルス、ビフィドバクテリウム・アニマリス(特にB.アニマリス・サブスピーシーズ・アニマリス)、ビフィドバクテリウム・インファンティス、ビフィドバクテリウム・ロンガム、ビフィドバクテリウム・ブレーベ、ラクトバチルス・アシドフィルス、ラクトバチルス・プランタラム、ラクトバチルス・カゼイ、ラクトバチルス・デルブルッキィー・サブスピーシーズ・ブルガリカス、ラクトコッカス・ラクティス、ラクトコッカス・ラクティス・サブスピーシーズ・ラクティス(ストレプトコッカス・ラクティス)、ストレプトコッカス・サーモフィルス、ビフィドバクテリウム・ラクチス、ビフィドバクテリウム・ブレーベ、ラクトバチルス・アシドフィルス、ラクトバチルス・プランタラム、ラクトバチルス・カゼイ、及びラクトバチルス・ヘルベティカス、並びにこれらの組み合わせからなる群から選択されている、請求項13に記載の方法。
- 前記プロモーターが、ポリ−L−リシン、グルコサミン、ポリ−L−アルギニン、ガラクトサミン、N−アセチルマンノサミン(NAM、N−Ac−Man)、N−アセチルグルコサミン(NAG、N−Ac−Glc)、N,N’−ジアセチルグルコサミン(NAG−NAG、N,N’−ジアセチルキトビオース)、N,N’,N”,N’”−テトラアセチルグルコサミン(NAG−NAG−NAG−NAG、N,N’,N”,N’”−テトラアセチルキトテトラオース)、及びこれらの混合物からなる群から選択されている、請求項13に記載の方法。
- 請求項13に記載の化合物を少なくとも1種含むキット。
- (i)少なくとも1種の追加の治療剤、(ii)少なくとも1種の一酸化窒素増大化合物、又は(iii)少なくとも1種の追加の治療剤、及び少なくとも1種の一酸化窒素増大化合物をさらに含む、請求項16に記載のキット。
- 対象におけるNod誘発性障害を軽減又は抑制する方法であって、
前記軽減又は抑制を必要とする対象に、
(a)グラム陽性菌由来の溶解産物若しくは細胞壁抽出物、又はその製薬学的に許容可能な塩と、
(b)プロモーターと、
(c)任意の担体と、
を含む組成物を有効量投与することを含み、
前記細胞壁溶解産物が、前記障害を治療するのに有効な量で存在し、
それにより、前記対象におけるNod誘発性障害を軽減又は抑制する方法。 - 前記Nodが、Nod1及びNod2のうちの1つ以上である、請求項17に記載の方法。
- 前記NodがNod2である、請求項17に記載の方法。
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