JP2021527670A - 筋肉中の脂肪浸潤の治療のための組成物及び方法 - Google Patents
筋肉中の脂肪浸潤の治療のための組成物及び方法 Download PDFInfo
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- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
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Abstract
Description
筋肉中の脂肪の浸潤の増加、たとえば筋萎縮に関連する、多くの疾患及び障害がある。筋萎縮は、癌、エイズ、腎不全、肝疾患、脊髄損傷、及びうっ血性心不全に関連する。さらに、固定又は加齢による筋肉の廃用もまた、筋肉中の脂肪流入の増加と共に筋萎縮をもたらす。
a)ロイシンアミノ酸実体、アルギニンアミノ酸実体、及びグルタミンアミノ酸実体;
b)N−アセチルシステイン(NAC)実体;並びに
c)ヒスチジンアミノ酸実体、リシンアミノ酸実体、フェニルアラニンアミノ酸実体、及びトレオニンアミノ酸実体から選ばれる必須アミノ酸(EAA)実体又は2、3、若しくは4つのEAAの組み合わせを含む。
a)ロイシンアミノ酸実体、アルギニンアミノ酸実体、及びグルタミンアミノ酸実体;
b)N−アセチルシステイン(NAC)実体、たとえばNAC;並びに
c)ヒスチジン(H)アミノ酸実体、リシン(K)アミノ酸実体、フェニルアラニン(F)アミノ酸実体、及びトレオニン(T)アミノ酸実体から選ばれる必須アミノ酸(EAA)実体又は2、3、若しくは4つのEAAの組み合わせを含むことができる。さらに、
d)少なくとも1つのアミノ酸実体は、長さが20アミノ酸残基を超えるペプチドとして提供されない。さらに別の態様では、
(i)(a)のアミノ酸実体は、表1から選択される;且つ
(ii)アルギニンアミノ酸実体及びグルタミンアミノ酸実体の一方又は両方は、ロイシンアミノ酸実体よりも多い量(wt.%)で存在する。
請求項及び明細書において使用される用語は、別段の定めがない限り、下記に記載されるように定義される。
AMINO ACID COMPOSITIONS AND METHODS FOR THE TREATMENT OF MUSCLE DISEASES AND DISORDERSと題する2017年12月19日に提出された米国特許出願公開第2018/0207119号明細書及びAMINO ACID COMPOSITIONS AND METHODS FOR THE TREATMENT OF LIVER DISEASESと題する2017年12月19日に提出された米国特許出願第15/847,289号明細書は、これらのそれぞれが、その全体が参照によって本明細書において明確に援用されるが、本明細書において記載される方法によって示すことができるように、筋肉中の脂肪浸潤を低下させてもよいアミノ酸実体、すなわち活性成分の組成物を開示する。
本明細書において記載される活性成分組成物は、筋肉中の脂肪浸潤を低下させるために投与することができる。筋肉中の脂肪浸潤は、筋萎縮の他の疾患及び障害と無関係の及び関連する筋機能及び移動性の重要な予測因子であり(たとえばAddison eta l.,2014,Int.J.Endocrinology,http://dx.doi.org/10.1155/2014/309570を参照)、他の併存症、たとえばサルコペニアと無関係に、肝硬変の合併症として確認された(たとえばBhanji et al.,2018,Hep.Intl.,https://doi.org/10.1007/s12072−018−9875−9を参照)。脂肪浸潤は、筋肉の質に影響を及ぼすので、したがって、筋肉中の脂肪浸潤を低下させることができる治療薬の確認は、重要な進展である。実施例において示されるように、LIVRQNacHFKT(上記に記載されるように、一文字アミノ酸コードを使用、NacはNACを意味する)を含有する例示的な活性成分は、ちょうど7日間固定された筋肉中の脂肪浸潤の有意な低下又はさらには回避さえも示した。今や活性成分として確認されているアミノ酸実体のこの種の活性な組み合わせについてのこの前例がない観察は、活性成分の投与の効果をモニターするための方法と同様に、療法を必要とする対象にとって、活性成分による療法の重要な新しい道を開く。
他の状態では、たとえば筋疾患又は障害を有する患者において、筋機能を改善する、たとえば向上させるために活性成分を投与することは、筋肉中の脂肪浸潤を判定することを含む。本開示はまた、固定、栄養失調、飢餓、加齢、オートファジー、タンパク質合成の低下、同化抵抗性、神経筋接合部完全性、インスリン抵抗性、ミトコンドリア新生の減少、アナプレロティック反応、又はエネルギー欠損から選択される1つ又はそれ以上の(たとえばすべての)生理学的症状を、筋肉中の脂肪浸潤を判定すると共に、各症例において治療するための方法を提供する。方法は、上記に記載されるように、有効量の組成物をその必要のある対象に投与することを含む。本発明による治療上の処置は、筋疾患、たとえば筋萎縮、サルコペニア、筋肉の劣化、筋肉の衰弱、悪液質、医薬誘発性のミオパチー、筋ジストロフィー、又はミオペニアを有する対象において実現することができる。筋疾患又は障害は、筋緊張性ジストロフィーなどのようなジストロフィーとすることができる。たとえば、筋疾患又は障害は、DM1とすることができる。
組成物は、本明細書において記載される用法・用量に従ってヒト対象に投与することができる。
組成物を作製するために使用されるアミノ酸は、分散及び/又は可溶化を助けるために、1つにまとめられてもよい及び/又はインスタント化されてもよい。
本開示のアミノ酸組成物は、1つ又はそれ以上の賦形剤と共に調合されてもよい又は製剤されてもよい。適している賦形剤の非限定的な例は、味物質、香味料、緩衝剤、防腐剤、安定剤、バインダー、コンパクション剤(compaction agent)、潤滑剤、分散促進剤、崩壊剤、調味料、甘味料、及び着色料を含む。
アミノ酸実体を含む活性成分は、たとえば病人用特別食、機能性食品、又はサプリメントから選ばれる食物性組成物として製剤し、使用することができる。そのような実施形態では、原材料及び最終産物は、食料品の基準を満たすべきである。そのような使用は、加齢、損傷、萎縮、感染、又は疾患により筋肉中の脂肪の浸潤を有するか又はそれに罹患しているとして確認された対象の健康状態を改善することを含む。いくつかの実施形態では、対象は、筋肉の劣化、筋肉の衰弱、筋萎縮、悪液質、サルコペニア、ステロイドミオパチー、又は筋ジストロフィーを有するか又はそれを有するとして確認されている。いくつかの実施形態では、対象は、2型糖尿病又は比較的高いBMIの一方又は両方を有する。
本明細書において開示される方法のいずれも、たとえばCT又はMRIにより対象における筋肉中の脂肪の浸潤の程度を決定することによって、本明細書において記載される組成物の対象への投与の有効性を判定すること又はモニターすることを含むことができる。対象は、筋機能向上を必要としていてもよい(たとえば、対象は、筋肉の劣化、筋肉の衰弱、筋萎縮、悪液質、サルコペニア、医薬誘発性のミオパチー、筋ジストロフィー、又はミオペニアを有する)。対象の治療における組成物に対する有効性は、以下のものの1つ又はそれ以上(たとえばすべて)のレベルの判断基準をさらに含むことができる:
a)ミオスタチン;
b)ミオグロビン;
c)コルチゾール−AM;
d)C反応性タンパク質;
e)インスリン;
f)サイトカイン(たとえばIL−1A RBM、IL−1RA、IL−1 RI、IL−1 RII、IL−12、IL−18、若しくはMCP−1の1つ若しくはそれ以上(たとえばすべて));
g)GDF−11;
h)P3NP;
i)IGF−1;
j)IGFBP1;
k)IGFBP3;
l)FGF21;
m)DHEAS;
n)mTORC1;
o)Gcn2;又は
p)AMP活性化プロテインキナーゼ(AMPK)。
本明細書において記載される試験は、片側の膝が固定されている健康な対象への、アミノ酸を含む組成物の投与を特徴とする。本試験の目標は、7日間の1本の脚の固定及び14日間の固定後の回復の後に、筋萎縮に対するアミノ酸組成物の影響を決定することとした。組成物は、1日当たり3回の4本のスティックパック中、投与用スティック分包当たり、約1gのL−ロイシン、約0.5gのL−イソロイシン、約0.5gのL−バリン、約1.5gのL−アルギニン(又は1.81gのL−アルギニンHCl)、約1.33gのL−グルタミン、約0.15gのN−アセチルシステイン、約0.08gのL−ヒスチジン、約0.35gのL−リシン、約0.08gのL−フェニルアラニン、及び約0.17gのL−トレオニンを含んだ(たとえば、1日当たり合計約68若しくは72g又は約23g若しくは24gを1日当たり3回)。組成物はまた、表5に示されるように賦形剤をも含んだ。
FF=F/(W+F)、ここでF=脂肪及びW=水。
Claims (30)
- 筋肉中の脂肪浸潤を低下させるための方法であって、筋肉中に脂肪浸潤のリスクのある対象に、
a)ロイシンアミノ酸実体、アルギニンアミノ酸実体、及びグルタミンアミノ酸実体;
b)N−アセチルシステイン(NAC)実体;並びに
c)ヒスチジンアミノ酸実体、リシンアミノ酸実体、フェニルアラニンアミノ酸実体、及びトレオニンアミノ酸実体から選ばれる必須アミノ酸(EAA)実体又は2、3、若しくは4つのEAAの組み合わせ
を含む組成物を投与することを含む方法。 - 筋肉中に脂肪浸潤のリスクのある前記対象は、肩腱板損傷を有する、請求項1に記載の方法。
- 前記組成物の投与は、肩腱板損傷のための手術の前に行われる、請求項2に記載の方法。
- 手術の前に前記肩腱板損傷によって冒された肩筋肉中の脂肪浸潤のレベルを決定することをさらに含む、請求項2に記載の方法。
- 手術の後に前記肩腱板損傷によって冒された肩筋肉中の脂肪浸潤のレベルを決定することをさらに含む、請求項2に記載の方法。
- 前記対象は、高齢の対象である、請求項2に記載の方法。
- 筋肉中に脂肪浸潤のリスクのある前記対象は、慢性背部痛(傍脊柱筋群中の脂肪浸潤);HIV患者(運動に関係する筋肉中の脂肪浸潤);脊髄損傷;脳卒中;COPD;末期肝疾患(ESLD)、たとえば肝性脳症、静脈瘤出血、門脈圧亢進症、腹水症、感染リスク、敗血症、総入院率、並びに総死亡率及び肝臓関連死亡率;並びに老化に関連する筋力低下を有する、請求項1に記載の方法。
- 筋肉中に脂肪浸潤のリスクのある前記対象への組成物の投与は、グルコースを捕捉する筋機能を改善する、請求項1に記載の方法。
- 筋肉中に脂肪浸潤のリスクがある前記対象は、糖尿病又は代謝性疾患を有する、請求項8に記載の方法。
- 筋肉中に脂肪浸潤のリスクのある前記対象は、癌を有する、請求項1に記載の方法。
- 前記癌は、結腸直腸癌又は乳頭部周囲癌である、請求項10に記載の方法。
- 筋肉中に脂肪浸潤のリスクがある前記対象は、BMIの著しい増加、サルコペニア、又は他の明白な状態を有していない、請求項1に記載の方法。
- 筋肉中に脂肪浸潤のリスクがある前記対象は、サルコペニアを伴わない肝硬変に罹患している、請求項1に記載の方法。
- 筋肉中に脂肪浸潤のリスクがある前記対象は、ESLD、たとえば肝性脳症、静脈瘤出血、門脈圧亢進症、腹水症、感染リスク、敗血症、総入院率、並びに総死亡率及び肝臓関連死亡率を有する、請求項1に記載の方法。
- 筋肉中の脂肪浸潤の程度は、磁気共鳴画像法(MRI)によって決定される、請求項1に記載の方法。
- メチオニン(M)、トリプトファン(W)、バリン(V)、若しくはシステイン(C)の少なくとも1つは、不在であるか又は存在する場合、1重量(wt.)%未満で存在する、請求項1に記載の方法。
- (a)〜(c)の総wt.%は、前記組成物中の任意の他のアミノ酸実体の総wt.%よりも多い、請求項1に記載の組成物。
- 前記組成物は、イソロイシンアミノ酸実体、バリンアミノ酸実体、又はイソロイシンアミノ酸実体及びバリンアミノ酸実体の両方をさらに含む、請求項1〜17のいずれか一項に記載の方法。
- 前記ロイシンアミノ酸実体、前記アルギニンアミノ酸実体、前記グルタミンアミノ酸実体、又は1、2、3、若しくはすべての前記EAAアミノ酸実体の少なくとも1つは、遊離アミノ酸であり、前記組成物の総乾燥wt.の少なくとも50wt.%は、遊離形態をした1つ又はそれ以上のアミノ酸実体である、請求項1〜18のいずれか一項に記載の方法。
- 前記ロイシンアミノ酸実体、前記アルギニンアミノ酸実体、前記グルタミンアミノ酸実体、又は1、2、3、若しくはすべての前記EAAアミノ酸実体の少なくとも1つは、塩形態をしており、前記組成物の総乾燥wt.の少なくとも50wt.%は、塩形態をした1つ又はそれ以上のアミノ酸実体である、請求項1〜19のいずれか一項に記載の方法。
- 前記組成物は、約0.5g〜約15gのロイシンアミノ酸実体、約0.25g〜約10gのイソロイシンアミノ酸実体、約0.25g〜約10gのバリンアミノ酸実体、約0.5〜約25gのアルギニンアミノ酸実体、約0.5g〜約20gのグルタミンアミノ酸実体、約0.1〜約5gのNAC又はその塩、約0.05g〜約3gのL−ヒスチジン又はその塩、約0.05〜約6gのL−リシン又はその塩、約0.04〜約2gのL−フェニルアラニン又はその塩、及び約0.08〜約4gのL−トレオニン又はその塩の実体;たとえば、約1gのロイシンアミノ酸実体、約0.5gのイソロイシンアミノ酸実体、約0.5gのバリンアミノ酸実体、約1.5g又は約1.81gのアルギニンアミノ酸実体、約1.33gのグルタミンアミノ酸実体、約0.15g又は約0.3gのNAC又はその塩、約0.08gのL−ヒスチジン又はその塩、約0.35gのL−リシン又はその塩、約0.08gのL−フェニルアラニン又はその塩、及び約0.17gのL−トレオニン又はその塩を含む、請求項1〜20のいずれか一項に記載の方法。
- 前記組成物は、医薬組成物であり、薬学的に許容され得る賦形剤をさらに含む、請求項1〜21のいずれか一項に記載の方法。
- 脂肪浸潤を低下させることによって、移動性が低下したか又は固定された筋肉における筋機能を改善するための方法であって、前記方法は、少なくとも4つのアミノ酸を含む組成物の有効量をその必要のある対象に投与することを含み、前記組成物は、筋肉中の脂肪浸潤を低下させる方法。
- 脂肪浸潤は、移動性が低下したか又は固定された筋肉中で低下する、請求項23に記載の方法。
- 筋肉中の脂肪浸潤の程度を決定することをさらに含む、請求項23に記載の方法。
- 前記組成物は、
a)ロイシンアミノ酸実体、アルギニンアミノ酸実体、及びグルタミンアミノ酸実体;
b)N−アセチルシステイン(NAC)実体、たとえばNAC;並びに
c)ヒスチジンアミノ酸実体、リシンアミノ酸実体、フェニルアラニンアミノ酸実体、及びトレオニンアミノ酸実体から選ばれる必須アミノ酸(EAA)実体又は2、3、若しくは4つのEAAの組み合わせ
を含み、ただし
d)少なくとも1つのアミノ酸実体は、長さが20アミノ酸残基を超えるペプチドとして提供されないことを条件とし、
(i)(a)のアミノ酸実体は、表1から選択され;且つ
(ii)前記アルギニンアミノ酸実体及び前記グルタミンアミノ酸実体の一方又は両方は、前記ロイシンアミノ酸実体よりも多い量(wt.%)で存在する、請求項23に記載の方法。 - 前記対象は、まれな筋疾患、筋萎縮、サルコペニア、筋肉の劣化、筋肉の衰弱、悪液質、医薬誘発性のミオパチー、筋ジストロフィー、ミオペニア、筋力低下、知覚された筋力低下、ICU関連ミオパチー、熱傷関連ミオパチー、神経筋障害、人工呼吸器誘発性の横隔膜ジストロフィー、低ナトリウム血症、低カリウム血症、カルシウム欠乏症、高カルシウム血症、筋萎縮性側索硬化症、骨低下症からなる群から選択される疾患若しくは障害を有し;又は前記対象は、加齢、損傷、筋萎縮、感染、疾患、脳卒中、又は骨折若しくは他の外傷による筋機能の減少を有し又は有するとして確認され、前記骨折又は他の外傷は、肩腱板の手術、膝の手術、腰の手術、関節置換術、損傷修復手術から選択されるか又はギブスを着用している、請求項23〜26のいずれか一項に記載の方法。
- 前記疾患若しくは前記障害、筋機能の減少、又は骨折若しくは他の外傷を治療する際の前記組成物の投与の有効性を判定するために、前記対象において筋肉中の脂肪浸潤を判定することを含む、請求項23〜27のいずれか一項に記載の方法。
- 少なくとも4つのアミノ酸を含む組成物が筋機能に関連する疾患又は障害を治療する際に有効であるかどうかを決定するための方法であって、少なくとも4つのアミノ酸を含む組成物を前記対象に投与すること及び前記対象において筋肉中の脂肪浸潤の低下があるかどうかを決定することを含む方法。
- 脂肪浸潤は、筋機能に関連する前記疾患又は障害によって冒された筋組織中のものである、請求項29に記載の方法。
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2019
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- 2019-06-19 MA MA052971A patent/MA52971A/fr unknown
- 2019-06-19 US US16/446,328 patent/US10596136B2/en active Active
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JP2017501113A (ja) * | 2013-10-23 | 2017-01-12 | ホワイトヘッド・インスティテュート・フォー・バイオメディカル・リサーチ | アミノ酸によるmTORC1の調節およびその使用 |
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US20210290573A1 (en) | 2021-09-23 |
WO2019246225A1 (en) | 2019-12-26 |
TW202015666A (zh) | 2020-05-01 |
CN112839643A (zh) | 2021-05-25 |
US11833127B2 (en) | 2023-12-05 |
US20200016104A1 (en) | 2020-01-16 |
MA52971A (fr) | 2021-04-28 |
US10973793B2 (en) | 2021-04-13 |
US10596136B2 (en) | 2020-03-24 |
AR115585A1 (es) | 2021-02-03 |
EP3810123A1 (en) | 2021-04-28 |
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