JPWO2019164914A5 - Compounds and compositions for treating myopathy and bone disorders - Google Patents
Compounds and compositions for treating myopathy and bone disorders Download PDFInfo
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- 239000000203 mixture Substances 0.000 title claims description 50
- 150000001875 compounds Chemical class 0.000 title claims description 7
- 208000003432 Bone Disease Diseases 0.000 title 1
- 206010028640 Myopathy Diseases 0.000 title 1
- 201000010770 muscular disease Diseases 0.000 title 1
- 201000009623 myopathy Diseases 0.000 title 1
- PFTAWBLQPZVEMU-ZFWWWQNUSA-N (+)-epicatechin Chemical compound C1([C@@H]2OC3=CC(O)=CC(O)=C3C[C@@H]2O)=CC=C(O)C(O)=C1 PFTAWBLQPZVEMU-ZFWWWQNUSA-N 0.000 claims description 40
- 210000000988 Bone and Bones Anatomy 0.000 claims description 30
- PFTAWBLQPZVEMU-DZGCQCFKSA-N (+)-3',4',5,7-Tetrahydroxy-2,3-trans-flavan-3-ol Natural products C1([C@H]2OC3=CC(O)=CC(O)=C3C[C@@H]2O)=CC=C(O)C(O)=C1 PFTAWBLQPZVEMU-DZGCQCFKSA-N 0.000 claims description 27
- 235000007246 (+)-epicatechin Nutrition 0.000 claims description 20
- 235000007355 (-)-epicatechin Nutrition 0.000 claims description 20
- 229930013783 (-)-epicatechin Natural products 0.000 claims description 20
- 238000004519 manufacturing process Methods 0.000 claims description 15
- 230000003313 weakening Effects 0.000 claims description 13
- 230000001771 impaired Effects 0.000 claims description 12
- 239000000651 prodrug Substances 0.000 claims description 11
- 229940002612 prodrugs Drugs 0.000 claims description 11
- 150000003839 salts Chemical class 0.000 claims description 10
- 239000011780 sodium chloride Substances 0.000 claims description 10
- 230000011164 ossification Effects 0.000 claims description 9
- 239000002246 antineoplastic agent Substances 0.000 claims description 5
- 230000037396 body weight Effects 0.000 claims description 5
- 206010065687 Bone loss Diseases 0.000 claims description 4
- 206010061363 Skeletal injury Diseases 0.000 claims description 4
- 230000001773 anti-convulsant Effects 0.000 claims description 4
- 239000001961 anticonvulsive agent Substances 0.000 claims description 4
- 239000003246 corticosteroid Substances 0.000 claims description 4
- 229960004015 Calcitonin Drugs 0.000 claims description 3
- 102400000113 Calcitonin Human genes 0.000 claims description 3
- 108060001064 Calcitonin Proteins 0.000 claims description 3
- 229960005069 Calcium Drugs 0.000 claims description 3
- 102000016970 Follistatin Human genes 0.000 claims description 3
- 108010014612 Follistatin Proteins 0.000 claims description 3
- 210000003205 Muscles Anatomy 0.000 claims description 3
- 208000001132 Osteoporosis Diseases 0.000 claims description 3
- 229940046008 Vitamin D Drugs 0.000 claims description 3
- 229930003316 Vitamin D Natural products 0.000 claims description 3
- 230000002730 additional Effects 0.000 claims description 3
- BBBFJLBPOGFECG-VJVYQDLKSA-N calcitonin Chemical compound N([C@H](C(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC=1NC=NC=1)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)NCC(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H]([C@@H](C)O)C(=O)N1[C@@H](CCC1)C(N)=O)C(C)C)C(=O)[C@@H]1CSSC[C@H](N)C(=O)N[C@@H](CO)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)O)C(=O)N1 BBBFJLBPOGFECG-VJVYQDLKSA-N 0.000 claims description 3
- OYPRJOBELJOOCE-UHFFFAOYSA-N calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims description 3
- 229910052791 calcium Inorganic materials 0.000 claims description 3
- 239000011575 calcium Substances 0.000 claims description 3
- 239000003814 drug Substances 0.000 claims description 3
- 102000004169 proteins and genes Human genes 0.000 claims description 3
- 108090000623 proteins and genes Proteins 0.000 claims description 3
- 230000008929 regeneration Effects 0.000 claims description 3
- 238000011069 regeneration method Methods 0.000 claims description 3
- 235000019166 vitamin D Nutrition 0.000 claims description 3
- 239000011710 vitamin D Substances 0.000 claims description 3
- 150000003710 vitamin D derivatives Chemical class 0.000 claims description 3
- 229940100626 Catechin Drugs 0.000 claims 1
- 229950001002 Cianidanol Drugs 0.000 claims 1
- 229930016253 catechin Natural products 0.000 claims 1
- 235000005487 catechin Nutrition 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 230000035876 healing Effects 0.000 claims 1
- PFTAWBLQPZVEMU-UKRRQHHQSA-N (-)-epicatechin Chemical compound C1([C@H]2OC3=CC(O)=CC(O)=C3C[C@H]2O)=CC=C(O)C(O)=C1 PFTAWBLQPZVEMU-UKRRQHHQSA-N 0.000 description 14
- 150000002116 epicatechin Chemical class 0.000 description 8
- OMFXVFTZEKFJBZ-HJTSIMOOSA-N Corticosterone Chemical compound O=C1CC[C@]2(C)[C@H]3[C@@H](O)C[C@](C)([C@H](CC4)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 OMFXVFTZEKFJBZ-HJTSIMOOSA-N 0.000 description 1
- 229940079593 drugs Drugs 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 230000001939 inductive effect Effects 0.000 description 1
- 238000007918 intramuscular administration Methods 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 150000003431 steroids Chemical class 0.000 description 1
- 230000001225 therapeutic Effects 0.000 description 1
Description
上述の方法の実施形態のいずれにおいても、（＋）エピカテキン及び／若しくは（－）エピカテキン又はエピカテキン誘導体は、任意選択的に経口的又は静脈内又は筋肉内に１日につき５ｍｇ～２グラム及び／又は単回用量若しくは分割用量で投与してよい。
本発明のまた別の態様は、以下のとおりであってもよい。
〔１〕必要とする対象において、骨に対する傷害若しくは骨の喪失を反転若しくは改善する、又は骨折を予防する方法であって、（＋）エピカテキン及び／若しくは（－）エピカテキン又はエピカテキン誘導体の治療的有効用量を対象に投与することを含む、方法。
〔２〕前記（＋）エピカテキン及び／若しくは（－）エピカテキン又はエピカテキン誘導体が１日につき５ｍｇ～２グラム、単回用量又は分割用量で経口投与、静脈内投与又は筋肉内投与される、前記〔１〕に記載の方法。
〔３〕前記（＋）エピカテキン及び／若しくは前記（－）エピカテキン又はエピカテキン誘導体が、１日につき０．１ｍｇ／ｋｇ体重～１日につき１０ｍｇ／ｋｇ体重の用量にて、単回用量又は分割用量で、経口投与又は静脈内投与又は筋肉内投与される、前記〔１〕に記載の方法。
〔４〕前記方法が、骨折を防止するために、新たな骨形成若しくは追加の骨形成、又はより強度の骨形成若しくは再生を誘起する、前記〔１〕に記載の方法。
〔５〕前記方法が、骨の弱化を反転又は改善し、これにより、骨の弱化又は骨に対する損傷、骨生成の障害、又は骨成長の障害を誘起することが既知である化合物の投与によって引き起こされる骨折を防止し、前記化合物が、コルチコステロイド抗痙攣剤、化学療法薬からなる群から選択される、前記〔１〕に記載の方法。
〔６〕前記骨の弱化が、骨の弱化若しくは骨に対する損傷、骨生成の障害又は骨成長の障害に関連することが既知である医学的状態によって引き起こされる、前記〔１〕に記載の方法。
〔７〕前記（＋）エピカテキン及び／又は（－）エピカテキンが、カルシウム、ビタミンＤ又はカルシトニンと同時投与される、前記〔１〕に記載の方法。
〔８〕前記（＋）エピカテキン及び／若しくは（－）エピカテキン又はエピカテキン誘導体が、１日につき５ｍｇ～２グラム、単回用量又は分割用量で経口投与、静脈内投与又は筋肉内投与される、前記〔４〕に記載の方法。
〔９〕前記（＋）エピカテキン及び／若しくは（－）エピカテキン又はエピカテキン誘導体が、１日につき５ｍｇ～２グラム、単回用量又は分割用量で経口投与、静脈内投与又は筋肉内投与される、前記〔５〕に記載の方法。
〔１０〕前記（＋）エピカテキン及び／若しくは（－）エピカテキン又はエピカテキン誘導体が、１日につき５ｍｇ～２グラム、単回用量又は分割用量で経口投与、静脈内投与又は筋肉内投与される、前記〔６〕に記載の方法。
〔１１〕前記（＋）エピカテキン及び／若しくは（－）エピカテキン又はエピカテキン誘導体が、１日につき５ｍｇ～２グラム、単回用量又は分割用量で経口投与、静脈内投与又は筋肉内投与される、前記〔７〕に記載の方法。
〔１２〕（＋）エピカテキン、（－）エピカテキン又は両方の混合物又はその薬学的に許容される塩若しくはプロドラッグを含む、又は（＋）エピカテキン、（－）エピカテキン又は両方の混合物又はその薬学的に許容される塩若しくはプロドラッグからなる組成物であって、
（ａ）骨に対する傷害若しくは骨の喪失を反転若しくは改善する、又は骨折を防止する、及び／又は
（ｂ）骨粗鬆症を予防、処置若しくは治癒する、薬剤として使用するための、組成物。
〔１３〕前記（＋）エピカテキン、（－）エピカテキン若しくはその両方の混合物又はその薬学的に許容される塩若しくはプロドラッグが、経口投与又は静脈内投与又は筋肉内投与されることを特徴とする、前記〔１２〕に記載の組成物。
〔１４〕前記（＋）エピカテキン、（－）エピカテキン若しくはその両方の混合物又はその薬学的に許容される塩若しくはプロドラッグが、１日につき５ｍｇ～２グラム、単回用量又は分割用量で投与されることを特徴とする、前記〔１２〕及び／又は１３に記載の組成物。
〔１５〕前記（＋）エピカテキン、（－）エピカテキン若しくはその両方の混合物又はその薬学的に許容される塩若しくはプロドラッグが、１日につき０．１ｍｇ／ｋｇ体重～１日につき１０ｍｇ／ｋｇ体重の用量にて、単回用量又は分割用量で、１日につき１０ｍｇ／ｋｇ体重の用量にて、経口投与又は静脈内投与又は筋肉内投与されることを特徴とする、前記〔１２〕～〔１４〕のいずれかに記載の組成物。
〔１６〕前記組成物が、骨折を防止するために、新たな骨形成若しくは追加の骨形成、又はより強度の骨形成若しくは再生を誘起することを特徴とする、前記〔１２〕～〔１５〕のいずれか一項に記載の組成物。
〔１７〕前記骨の弱化又は喪失が、骨の弱化又は骨に対する損傷、骨生成の障害、又は骨成長の障害を誘起することが既知である化合物の投与によって引き起こされ、前記化合物が、コルチコステロイド抗痙攣剤及び化学療法薬又はその混合物からなる群から選択されることを特徴とする、前記〔１２〕～〔１６〕のいずれかに記載の組成物。
〔１８〕前記骨の弱化が、骨の弱化若しくは骨に対する損傷、骨生成の障害又は骨成長の障害に関連することが既知である医学的状態によって引き起こされることを特徴とする、前記〔１２〕～〔１７〕のいずれかに記載の組成物。
〔１９〕前記組成物が、カルシウム、ビタミンＤ若しくはカルシトニン又はその混合物を更に含むことを特徴とする、前記〔１２〕～〔１８〕のいずれかに記載の組成物。
〔２０〕前記組成物が、コルチコステロイド抗痙攣剤、化学療法薬又はその混合物を更に含むことを特徴とする、前記〔１２〕～〔１９〕のいずれか一項に記載の組成物。
〔２１〕前記組成物が、フォリスタチン及びフォリスタチン様タンパク質の細胞産生又は筋産生又は体内産生を増加させることを特徴とする、前記〔１２〕～〔２０〕のいずれかに記載の組成物。
〔２２〕前記治療用量が、フォリスタチン及びフォリスタチン様タンパク質の細胞産生又は筋肉産生又は身体産生を増加させる、前記〔１〕に記載の方法。
In any of the embodiments of the method described above, (+) epicatechin and / or (-) epicatechin or epicatechin derivative is optionally taken orally or intravenously or intramuscularly in an amount of 5 mg to 2 grams per day. And / or may be administered in single or divided doses.
Another aspect of the present invention may be as follows.
[1] A method for reversing or ameliorating bone injury or bone loss, or preventing fractures in a required subject, of (+) epicatechin and / or (-) epicatechin or epicatechin derivative. A method comprising administering to a subject a therapeutically effective dose.
[2] The (+) epicatechin and / or (-) epicatechin or epicatechin derivative is orally administered, intravenously or intramuscularly in a single dose or a divided dose at 5 mg to 2 g per day. The method according to the above [1].
[3] The (+) epicatechin and / or the (-) epicatechin or the epicatechin derivative is administered in a single dose or at a dose of 0.1 mg / kg body weight per day to 10 mg / kg body weight per day. The method according to the above [1], which is administered orally, intravenously or intramuscularly in divided doses.
[4] The method according to the above [1], wherein the method induces new bone formation or additional bone formation, or stronger bone formation or regeneration in order to prevent fracture.
[5] The method is caused by administration of a compound known to reverse or ameliorate bone weakness, thereby inducing bone weakening or damage to bone, impaired bone production, or impaired bone growth. The method according to [1] above, wherein the compound is selected from the group consisting of a corticosteroid anticonvulsant and a chemotherapeutic agent.
[6] The method according to [1] above, wherein the bone weakening is caused by a medical condition known to be associated with bone weakening or damage to bone, impaired bone production or impaired bone growth.
[7] The method according to [1] above, wherein the (+) epicatechin and / or (-) epicatechin is co-administered with calcium, vitamin D or calcitonin.
[8] The (+) epicatechin and / or (-) epicatechin or epicatechin derivative is orally administered, intravenously or intramuscularly in a single dose or a divided dose of 5 mg to 2 g per day. , The method according to the above [4].
[9] The (+) epicatechin and / or (-) epicatechin or epicatechin derivative is orally administered, intravenously or intramuscularly in a single dose or a divided dose of 5 mg to 2 g per day. , The method according to the above [5].
[10] The (+) epicatechin and / or (-) epicatechin or epicatechin derivative is orally administered, intravenously or intramuscularly in a single dose or a divided dose of 5 mg to 2 g per day. , The method according to the above [6].
[11] The (+) epicatechin and / or (-) epicatechin or epicatechin derivative is orally administered, intravenously or intramuscularly in a single dose or a divided dose of 5 mg to 2 g per day. , The method according to the above [7].
[12] Containing (+) epicatechin, (-) epicatechin or a mixture thereof or a pharmaceutically acceptable salt or prodrug thereof, or (+) epicatechin, (-) epicatechin or a mixture thereof or both. A composition comprising the pharmaceutically acceptable salt or prodrug.
(A) Reversing or ameliorating bone injury or bone loss, or preventing fractures and / or
(B) A composition for use as a drug for preventing, treating or curing osteoporosis.
[13] The above (+) epicatechin, (-) epicatechin or a mixture thereof, or a pharmaceutically acceptable salt or prodrug thereof is characterized by oral administration, intravenous administration, or intramuscular administration. The composition according to the above [12].
[14] The (+) epicatechin, (-) epicatechin or a mixture thereof, or a pharmaceutically acceptable salt or prodrug thereof is administered in a single dose or a divided dose of 5 mg to 2 g per day. The composition according to [12] and / or 13 above, characterized in that.
[15] The (+) epicatechin, (-) epicatechin or a mixture thereof, or a pharmaceutically acceptable salt or prodrug thereof is 0.1 mg / kg body weight per day to 10 mg / kg per day. [12]-[. 14] The composition according to any one of.
[16] The above-mentioned [12] to [15], wherein the composition induces new bone formation or additional bone formation, or stronger bone formation or regeneration in order to prevent fracture. The composition according to any one of the above.
[17] The weakening or loss of bone is caused by administration of a compound known to induce weakening or damage to bone, impaired bone production, or impaired bone growth, wherein the compound is cortico. The composition according to any one of [12] to [16] above, which is selected from the group consisting of a steroid anticonvulsant and a chemotherapeutic agent or a mixture thereof.
[18] The weakening of the bone is caused by a medical condition known to be associated with weakening or damage to the bone, impaired bone production or impaired bone growth, said [12]. The composition according to any one of [17].
[19] The composition according to any one of [12] to [18] above, wherein the composition further contains calcium, vitamin D or calcitonin or a mixture thereof.
[20] The composition according to any one of the above [12] to [19], wherein the composition further comprises a corticosteroid anticonvulsant, a chemotherapeutic agent or a mixture thereof.
[21] The composition according to any one of [12] to [20] above, wherein the composition increases cell production or muscle production or in-vivo production of follistatin and follistatin-like protein.
[22] The method according to [1] above, wherein the therapeutic dose increases cell production or muscle production or body production of follistatin and follistatin-like protein.
Claims (11)
（ａ）骨に対する傷害若しくは骨の弱化若しくは骨の喪失を反転若しくは改善する、又は骨折を防止する、及び／又は
（ｂ）骨粗鬆症を予防、処置若しくは治癒する
ための医薬として使用するための、組成物。 Contains (+) epicatechin, (-) epicatechin or a mixture thereof or a pharmaceutically acceptable salt or prodrug thereof, or ( +) epicatechin, (-) epicatechin or a mixture thereof or a pharmacy thereof. A composition consisting of a catechin or a prodrug that is acceptable to the patient.
(A) Reversing or ameliorating bone injury or bone weakening or bone loss, or preventing fractures, and / or (b) Preventing, treating or healing osteoporosis
A composition for use as a medicine for.
（ａ）骨に対する傷害若しくは骨の弱化若しくは骨の喪失を反転若しくは改善する、又は骨折を防止するため、及び／又は (A) To reverse or ameliorate bone injury or bone weakening or bone loss, or to prevent fractures and / or
（ｂ）骨粗鬆症を予防、処置若しくは治癒するため (B) To prevent, treat or cure osteoporosis
の医薬の製造における使用。Use in the manufacture of pharmaceuticals.
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| PCT/US2019/018730 WO2019164914A1 (en) | 2018-02-20 | 2019-02-20 | Compounds and compositions for the treatment of muscular disorders |
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| US11918570B2 (en) | 2020-04-13 | 2024-03-05 | The Research Foundation For The State University Of New York | Method of treatment for prevention of glucocorticoid toxicity and/or enhancement of muscle regeneration via neutrophil elastase inhibition |
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| WO2003072714A2 (en) * | 2002-02-21 | 2003-09-04 | Wyeth | Follistatin domain containing proteins |
| JP2004161669A (en) * | 2002-11-13 | 2004-06-10 | Ito En Ltd | Osteogenic promoter |
| CN100361655C (en) * | 2005-09-05 | 2008-01-16 | 中山大学 | (-)-epigallocatechin gallate-calcium complex solid dispersion and its prepn and application |
| EP2162747B1 (en) * | 2007-06-20 | 2014-04-30 | Galapagos N.V. | Molecular targets and methods to identify compounds for treating bone and joint degenerative diseases |
| AU2009246053B2 (en) * | 2008-05-14 | 2014-07-24 | Agriculture Victoria Services Pty Ltd. | Use of angiogenin or angiogenin agonists for treating diseases and disorders |
| JP2010095474A (en) * | 2008-10-17 | 2010-04-30 | Ito En Ltd | Calcium absorption-promoting composition and calcium absorption-promoting food and drink |
| KR101096574B1 (en) * | 2008-12-12 | 2011-12-20 | 에이치 엘 지노믹스(주) | Pharmaceutical composition for preventing or treating osteoporosis comprising Vitis vinifera pip extract |
| JP2011006355A (en) * | 2009-06-25 | 2011-01-13 | Ito En Ltd | Composition and food and drink for improving bone density |
| JP2013051920A (en) * | 2011-09-05 | 2013-03-21 | Ishikawa Prefectural Public Univ Corp | Bone density improving supplement |
| EP2827856A4 (en) * | 2012-03-23 | 2016-03-09 | Cardero Therapeutics Inc | Compounds and compositions for the treatment of muscular disorders |
| US9579347B2 (en) * | 2012-10-04 | 2017-02-28 | Abbott Laboratories | Methods for enhancing the effect of EGCg on mitigating skeletal muscle loss |
| JP6340440B2 (en) * | 2014-06-16 | 2018-06-06 | ユニゲン・インコーポレーテッド | Composition and method for management or improvement of bone disorder, cartilage disorder or both |
-
2019
- 2019-02-20 JP JP2020544632A patent/JP2021514380A/en active Pending
- 2019-02-20 AU AU2019224003A patent/AU2019224003A1/en active Pending
- 2019-02-20 EP EP19756654.0A patent/EP3755319A4/en not_active Withdrawn
- 2019-02-20 CA CA3091892A patent/CA3091892A1/en active Pending
- 2019-02-20 BR BR112020016923-4A patent/BR112020016923A2/en not_active Application Discontinuation
- 2019-02-20 CN CN201980026811.XA patent/CN111989098A/en active Pending
- 2019-02-20 WO PCT/US2019/018730 patent/WO2019164914A1/en unknown
-
2020
- 2020-08-18 IL IL276786A patent/IL276786A/en unknown
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