JP6856968B2 - 自閉症スペクトラム障害および関連する症候を治療するための方法 - Google Patents
自閉症スペクトラム障害および関連する症候を治療するための方法 Download PDFInfo
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Description
本願は、2015年5月22日に出願された、米国仮特許出願第62/165,556号に対する優先権利益を主張し、その全体が、参照により本明細書に組み込まれる。
週後に測定され、治療前のリーター得点と比較される。一態様において、前述のシステムのうちのいずれか1つによる症候の改善は、治療の少なくとも2、4、6、8、10週間以上の治療の中止後に測定され、治療前の測定値と比較される。
(a)抗生物質をヒト対象に投与することと、
(b)ヒト対象に腸管洗浄を受けさせることと、
(c)精製されたふん便細菌叢をヒト対象に投与することであって、ヒト対象における自閉症スペクトラム障害が治療される、投与することと、を含む、方法。
(a)非吸収性抗生物質を自閉症のヒト対象に経口投与することと、
(b)自閉症のヒト対象に腸管洗浄を受けさせることと、
(c)定型発達のヒト提供者からヒト対象に精製されたふん便細菌叢を投与することであって、ヒト対象が、本方法の開始前と比較して本方法後に、小児自閉症評価尺度(CARS)によって評価されるような、自閉症の症候の重症度における有意な減少を示す、投与することと、を含む、方法。
FDAおよびASUの人体実験委員会(The FDA and ASU’s Human Subject Board)は、胃腸細菌叢の機能を改善することによって自閉症の症候を減少させるように設計された、ふん便細菌叢に基づく治療の安全性および耐容性を評価する試験に参加する、7〜17歳の20人の自閉症の子どもの予備的試験を認可した。本明細書に記載される場合、この治療は、健康なヒトからの精製された腸内細菌を、自閉症スペクトラム障害を有すると診断された子どもに移転することを含む。
試験は、我々のADI−R評価者との保護者の電話面接を含む、自閉症診断面接改訂版(ADI−R)を使用した自閉スペクトラム症の診断の評価により開始された。試験医は、除外基準についてチェックするために、最初の30分の参加者との面談を通した一般的な身体的健康、および参加者の直近2年の医療記録および身長/体重/成長曲線の広範囲の報告を評価した。参加者の除外基準には、直近6カ月の抗生物質、および直近3カ月の生菌、一遺伝子疾患、主な脳形成異常、経管栄養、緊急の治療を必要とする(生命に関わる)重度のGI障害、潰瘍性結腸炎、クローン病、診断されたセリアック病、好酸球性胃腸炎、重度の低体重/栄養不良、ならびに最近の/予定されている外科手術が含まれる。定型発達の子どものいずれも、ASD、ADHD、うつ症候、および不安を含む精神疾患を有していると診断されておらず、定型発達の子どもは、ASDを有する個人の第1度親近者がいなかった。参加者から、我々は、最初の血液、尿、およびふん便試料を収集し、試験の開始時に1週間参加者の子どもの食事日記を記入するように保護者に求めた。主にアリゾナ地域のグレーターフェニックスから参加者を募集したが、3人の参加者は、この地域以外だった。ASD家族の友人およびASD家族を扱う仕事をしている専門家から、定型発達の家族を募集した。
中程度〜重度のGI障害および中程度〜高度の認知的機能を有する7〜17歳の年齢の18人の自閉症の参加者(各々異なる家族から)。20人の参加者を試験に募集したが、2人は、治療の開始前に治療期の試験に参加しなかった。1人の参加者は、薬剤の変更に起因して不適格とみなされ、1人は、参加しないと決断した。18人の試験参加者の特徴および彼らの医療歴を、表2に列挙している。治療期に参加したすべての18人の参加者が、19週の試験を完了した。本明細書に提示されている治療後のデータは、これらの18人の参加者のうちの13人について収集された。加えて、13組の家族からの20人の年齢および性別の一致した定型発達の子ども(6組の家族が、1人の定型発達の参加者を有しており、7組の家族が、2人の定型発達の参加者を有していた)も募集している。これらの20人の定型発達の子どもを、18週間観察したが、治療を受けなかった。
病原性細菌のレベルを減少させるために、経口バンコマイシン(GI管中に留まる非吸収性広域スペクトル抗生物質)を2週間、次に、残存するバンコマイシンおよびふん便を除去するために、低容積結腸内視鏡検査前処置のMoviPrep(登録商標)(大部分の残存する腸内細菌およびバンコマイシンを除去するために、腸を洗浄する飲料)を1日、参加者に与えた。バンコマイシンは、有害な細菌を全滅させることを企図しており、断食は、任意の残存する細菌を除去し、他の内腔のふん便物質を最小にすることを企図しており、結腸の洗浄は、バンコマイシンの除去および下GI管の洗浄を助けとなった。
ヒトふん便からの高度に精製され標準化された抽出物(標準化ヒト腸内細菌叢(SHGM)とも呼ばれる)を含む、ヒト細菌叢調製物を使用した。これは、非常に健康な提供者の腸内に存在するすべての細菌を含有する全スペクトル製品である。最初に、最適なGIおよび全般的な健康を確実にするために、広範囲の健康アンケートおよび広範囲の医療検査を用いて、提供者を厳重にスクリーニングし、スクリーニングプロセスは、非常に厳密であるため、提供者の90%が除去され、個体群の10%のみの最も健康な部分を残す。次に、提供された物質を広範囲に濾過し、医薬品および医薬部外品の製造管理および品質管理の基準(GMP)に従って標準化した。最終的な製品は、冷凍することができる液体形態であり、C.difficile(Hamilton et al.、Am J Gastroenterol.2012 May;107(5):761−7)の治療に非常に有効であることが証明された。SHGMを、−80℃の冷凍庫で保存し、次に、試験中毎週ドライアイスで家族に送達した。家族は、SHGMを、ドライアイスを含む容器内に保持し、使用の直前に解凍するように指示を受けた。
バンコマイシン:バンコマイシンは、2種類の小さい有害事象と関連した。1人の子どもが、経口バンコマイシンの投与時にアレルギー性皮疹を発症したが、オレンジの風味のないバンコマイシンに切り替えると、皮疹が消えた。18人中12人の子どもに、バンコマイシンに対する行動反応があり、これは、バンコマイシンの開始後1〜4日で始まり、大部分の事例で1〜3日間続いたが、1人の参加者に、3週間続く症候があった。7人の事例において、症候は、多動において軽度〜中程度の増加であり、5人の事例において、症候は、癇癪/攻撃性において、軽度〜中程度の増加であった。これらの行動症候が消えた後、GI症候および自閉症の症候の改善が始まった。前試験(Sandler、2000)において、同様の結果が報告され、対象とされる試験の保護者は、これが期待されるとの報告を受けていた。バンコマイシンは有害な細菌を全滅させるため、反応は、細菌毒素の放出に起因している可能性がある。
ASDを罹患している子どもは、バンコマイシン治療の開始時に一時的な副作用を経験した。表4に列挙されているように、18人のASDを罹患している子どもの内1人の参加者(5%)が、広範な皮疹を発症したが、バンコマイシンが自然なオレンジの風味から風味付けされていない形態に切り替えされたときに、皮疹が消えた。バンコマイシンの開始後1〜4日以内に、12人のASDを罹患している子どもに、多動(12人の事例中7人、39%)または癇癪/攻撃性(12人の事例中5人、28%)のいずれかを含む、バンコマイシンに対する一時的な行動反応があった。症候は、症候が3週間続いた1人参加者を除いて、大部分の事例において、1〜3日続いた。症候が消えた後、自閉症を有する子どもに対するその経口バンコマイシン療法において、Sandler et al.、Journal of Child Neurology 15、429−35、(2000)が報告しているものと同様の、GI症候および行動症候の改善が始まった。1人のみの参加者が、最初の高用量経口SHGM(吐き気/嘔吐)を耐容せず、最初の直腸投与に切り替えられた。
胃腸症候評価尺度(GSRS)は、次に、5つの領域:腹痛、逆流、消化不良、下痢、および便秘において得点される、15個の質問に基づく前週中のGI症候の評価である。我々は、その領域における質問内の平均に基づく各領域に対する得点を報告している。元のGSRSは、4段階評価を使用していたが、我々は、より単純な言語も有する、リッカートの7段階評価を含む改訂版を使用した。GSRSは、0、7、14、21、28、35、42、56、74、および130日目に評価された。GSRSは、GI症候を評価するための唯一の方法であることを、当業者であれば理解する。GI症候を評価するために、他の同様のツールを使用するか、または設計することができる。
自閉症診断面接改訂版(ADI−R)は、2時間の構成的な面談であり、自閉症および自閉症スペクトラム障害の臨床診断のために使用される主要なツールのうちの1つである。これは、自閉症の重症度の評価基準となるように設計されていないが、より高い得点は、一般的に、より重度の症候と一致する。ADI−Rを使用して、試験の許可のためのASDの診断を実証した。
GI症候:2週間のバンコマイシン、次に8週間の有益な細菌の間、大部分の子どもにおいてGI症候の迅速な改善があった。治療の終了時に、胃腸症候評価尺度(GSRS)に対する平均得点における82%の減少があった。(図1および図3)。図2および図5に示されているように、全4個のGSRSの下位尺度の領域(腹痛、消化不良、下痢、便秘)における、およそ等しい減少があった。子どものいずれも有意な逆流障害がなかったため、逆流の下位尺度における変化はなかった。18人中16人の子どもに、70%以上の減少があり、1人に、30%の減少があり、1人は、変化を示さなかった。直腸投与群および経口投与群の両方について、同様の結果が観察された。
臨床的に、この試験は、広範囲で成功した。第1に、すべてのASD参加者が、18週間の試験を完了した。第2に、胃腸症候評価尺度(GSRS)によって評価されたGI症候は、腹痛、消化不良、下痢、および便秘について有意に改善し、その結果、GSRSの平均得点は、治療の開始から終了までに82%低下し、治療の中止後8週で改善を維持した(基準値から77%の減少)(それぞれ、両側対t検定t=−9.45、P<0.001、t=−7.64、P<0.001)(図9、パネルa)。腹痛、消化不良、下痢、および便秘を含むGSRS評価の大部分の領域における一定かつ大幅な程度の改善(図10、パネルa)が観察された。試験の開始時に有意な逆流があった子どもはいなかったため、逆流における変化はほとんどなかった。注目すべきことに、2つの、一見すると反対のGI症候−下痢および便秘−が、MTT治療に有効に反応した。
Claims (18)
- 治療を必要とする対象における自閉症スペクトラム障害(ASD)に関連する社会的な対話における障害の治療に使用するための医薬組成物であって、
前記治療が、
第一の投薬予定にしたがって前記医薬組成物の誘導用量を前記対象に経口投与する工程であって、前記医薬組成物が、定型発達のヒト提供者のふん便試料からの実質的に完全なふん便細菌叢を含む、ふん便細菌調製物を含む、工程、および、
その後、前記第二の投薬予定にしたがって前記医薬組成物の維持用量を前記対象に経口投与する工程
を含み、
前記治療が、前記対象の社会的な対話における障害の重症度を減少させ、ならびに、
前記維持用量が、前記誘導用量未満である、
医薬組成物。 - 前記第一の投薬予定または第二の投薬予定が、少なくとも1日に1回、前記医薬組成物を投与する工程を含む、請求項1に記載の医薬組成物。
- 前記第二の投薬予定が、少なくとも1月間少なくとも1日1回、前記医薬組成物を前記対象に投与する工程を含む、請求項2に記載の医薬組成物。
- 前記第一の投薬予定が、少なくとも2日間少なくとも1日1回、前記医薬組成物を前記対象に投与する工程を含む、請求項1から3のいずれか一項に記載の医薬組成物。
- 前記第一の投薬予定が、少なくとも7日間少なくとも1日1回、前記医薬組成物を前記対象に投与する工程を含む、請求項1から4のいずれか一項に記載の医薬組成物。
- 前記誘導用量が、少なくとも約1×1011細胞を含む、請求項1から5のいずれか一項に記載の医薬組成物。
- 前記維持用量が、少なくとも約1×1010細胞を含む、請求項6に記載の医薬組成物。
- 前記治療が、少なくとも12週間連続して投与される、請求項1から7のいずれか一項に記載の医薬組成物。
- 前記治療が、前記治療の中止後少なくとも8週間、前記対象の前記社会的な対話における障害の減少において効果的である、請求項1から8のいずれか一項に記載の医薬組成物。
- 前記誘導用量の投与前に、抗生物質を前記対象に投与する工程をさらに含む、請求項1から9のいずれか一項に記載の医薬組成物。
- 前記抗生物質がバンコマイシンである、請求項10に記載の医薬組成物。
- 前記社会的な対話における障害の重症度の減少が、小児自閉症評価尺度(CARS)、小児自閉症評価尺度2−標準形式(CARS2−ST)、小児自閉症評価尺度2−高機能(CARS2−HF)、異常行動チェックリスト(ABC)、Vineland適応行動尺度第二版(VABS−II)、対人応答性尺度(SRS)、およびそれらの組合わせからなる群から選択された評価システムを用いて得られた測定に少なくとも部分的に基づいている、請求項1から11のいずれか一項に記載の医薬組成物。
- 前記対象が、治療の開始前に、一つまたは複数の胃腸(GI)症候を示し、かつ、
前記治療が、胃腸症候評価尺度(GSRS)を用いて得られた測定に基づいた一つまたは複数の胃腸(GI)症候の重症度を減少させる、請求項1から12のいずれか一項に記載の医薬組成物。 - カプセル、タブレット、粉末、および顆粒からなる群から選択される固体剤型の形態として投与される、請求項1に記載の医薬組成物。
- ポリエチレングリコール、脱脂乳、エリトリトール、アラビトール、ソルビトール、グルコース、フルクトース、アラニン、グリシン、プロリン、スクロース、ラクトース、リボース、トレハロース、ジメチルスルホキシド(DMSO)、グリセロール、またはそれらの組み合わせから成る群から選択される抗凍結剤を含む、請求項1から14のいずれか一項に記載の医薬組成物。
- 前記抗凍結剤が、トレハロースである、請求項15に記載の医薬組成物。
- 社会的な対話における障害における重症度の減少が、Vineland適応行動尺度(VABS)または保護者全般印象(PGI)によって得られた測定に基づく、請求項1に記載の医薬組成物。
- 前記治療が、少なくとも10週間連続して投与される、請求項1から8のいずれか一項に記載の医薬組成物。
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