JP7436524B2 - ハンチントン病及びその症状を治療するためのプリドピジン及びその類似体を含む組成物 - Google Patents
ハンチントン病及びその症状を治療するためのプリドピジン及びその類似体を含む組成物 Download PDFInfo
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- JP7436524B2 JP7436524B2 JP2021572628A JP2021572628A JP7436524B2 JP 7436524 B2 JP7436524 B2 JP 7436524B2 JP 2021572628 A JP2021572628 A JP 2021572628A JP 2021572628 A JP2021572628 A JP 2021572628A JP 7436524 B2 JP7436524 B2 JP 7436524B2
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- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
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Description
1.Mahant N, McCusker EA, Byth K, Graham S. Huntington's disease: Clinical correlates of disability and progression. Neurology. 2003;
2.Tabrizi SJ, Reilmann R, Roos RAC, Durr A, Leavitt B, Owen G, et al. Potential endpoints for clinical trials in premanifest and early Huntington's disease in the TRACK-HD study: Analysis of 24 month observational data. Lancet Neurol. 2012;
3.Tabrizi SJ, Scahill RI, Owen G, Durr A, Leavitt BR, Roos RA, et al. Predictors of phenotypic progression and disease onset in premanifest and early-stage Huntington's disease in the TRACK-HD study: Analysis of 36-month observational data. Lancet Neurol. 2013;
4.Mestre T, Ferreira J, Coelho MM, Rosa M, Sampaio C. Therapeutic interventions for disease progression in Huntington's disease. Cochrane Database of Systematic Reviews. 2009.
5.Mestre T, Ferreira J, Coelho MM, Rosa M, Sampaio C. Therapeutic interventions for symptomatic treatment in Huntington's disease. Cochrane Database of Systematic Reviews. 2009.
6.Frank S, Testa CM, Stamler D, Kayson E, Davis C, Edmondson MC, et al. Effect of deutetrabenazine on chorea among patients with huntington disease?: A randomized clinical trial. JAMA - J Am Med Assoc. 2016;
7.Shen V, Clarence-Smith K, Hunter C, Jankovic J. Safety and Efficacy of Tetrabenazine and Use of Concomitant Medications During Long-Term, Open-Label Treatment of Chorea Associated with Huntington's and Other Diseases. Tremor Other Hyperkinet Mov (N Y). 2013;
8.Johnston TH, Geva M, Steiner L, Orbach A, Papapetropoulos S, Savola J-M, et al. Pridopidine, a clinic-ready compound, reduces 3,4-dihydroxyphenylalanine-induced dyskinesia in Parkinsonian macaques. Mov Disord [Internet]. 2018 Dec 21 [cited 2019 Mar 11]; Available from: http://doi.wiley.com/10.1002/mds.27565
9.Hayashi T, Su T-. The Sigma Receptor: Evolution of the Concept in Neuropsychopharmacology. Curr Neuropharmacol. 2005;3(4):267-80.
10.Su TP, Hayashi T, Maurice T, Buch S, Ruoho AE. The sigma-1 receptor chaperone as an inter-organelle signaling modulator. Trends in Pharmacological Sciences. 2010.
11.Eddings CR, Arbez N, Akimov S, Geva M, Hayden MR, Ross CA. Pridopidine protects neurons from mutant-huntingtin toxicity via the sigma-1 receptor. Neurobiol Dis. 2019;
12.Ionescu A, Gradus T, Altman T, Maimon R, Saraf Avraham N, Geva M, et al. Targeting the Sigma-1 Receptor via Pridopidine Ameliorates Central Features of ALS Pathology in a SOD1G93A Model. Cell Death Dis [Internet]. 2019;10(3):210. Available from: http://www.nature.com/articles/s41419-019-1451-2
13.Smith-Dijak AI, Nassrallah WB, Zhang LYJ, Geva M, Hayden MR, Raymond LA. Impairment and restoration of homeostatic plasticity in cultured cortical neurons from a mouse model of huntington disease. Front Cell Neurosci. 2019;
14.Ryskamp D, Wu J, Geva M, Kusko R, Grossman I, Hayden M, et al. The sigma-1 receptor mediates the beneficial effects of pridopidine in a mouse model of Huntington disease. Neurobiol Dis [Internet]. 2017 Jan [cited 2019 Mar 12];97(Pt A):46-59. Available from: http://www.ncbi.nlm.nih.gov/pubmed/27818324
15.Geva M, Kusko R, Soares H, Fowler KD, Birnberg T, Barash S, et al. Pridopidine activates neuroprotective pathways impaired in Huntington Disease. Hum Mol Genet [Internet]. 2016 [cited 2019 Mar 12];25(18):3975-87. Available from: http://www.ncbi.nlm.nih.gov/pubmed/27466197
Claims (16)
- 前記医薬組成物が、前記プリドピジンまたは薬学的に許容されるその塩と、化合物1または薬学的に許容されるその塩とを含む、請求項1に記載の使用。
- 前記医薬組成物が、前記プリドピジン及び/または薬学的に許容されるその塩と、前記化合物1及び/または薬学的に許容されるその塩と、前記化合物4及び/または薬学的に許容されるその塩とを含む、請求項1に記載の使用。
- 前記医薬組成物が、最大10重量%の、前記化合物1及び前記化合物4の少なくとも一方、及び/または薬学的に許容されるその塩を含む、請求項1に記載の使用。
- 前記ヒト患者がハンチンチン遺伝子に36以上のCAGリピートを有する、請求項1に記載の使用。
- 前記医薬組成物が1日2回投与される、請求項1に記載の使用。
- 各投与で等量の前記医薬組成物が投与される、請求項6に記載の使用。
- 前記ヒト患者の機能的能力が、統一ハンチントン病評価尺度-全機能によって測定される、請求項1に記載の使用。
- 前記プリドピジンまたは薬学的に許容されるその塩を含む前記医薬組成物が、1日あたり10mgから90mgの間の用量で投与される、請求項1に記載の使用。
- 前記プリドピジンまたは薬学的に許容されるその塩を含む前記医薬組成物が、1日あたり90mgの用量で投与される、請求項1に記載の使用。
- 前記プリドピジンまたは薬学的に許容されるその塩を含む前記医薬組成物が、1日2回、45mgの用量で投与される、請求項10に記載の使用。
- 前記薬学的に許容される塩が、塩酸塩、臭化水素酸塩、ヨウ化水素酸塩、硝酸塩、過塩素酸塩、リン酸塩、酸-リン酸塩、硫酸塩、重硫酸塩、ギ酸、グルコン酸塩、グルカロネート、糖酸塩、イソニコチン酸塩、酢酸塩、アコネート、アスコルビン酸塩、ベンゼンスルホン酸塩、安息香酸塩、桂皮酸塩、クエン酸塩、エンボネート、エナンテート、フマル酸塩、グルタミン酸塩、グリコール酸塩、乳酸塩、マレイン酸塩、ゲンチシン酸塩、マロン酸塩、マンデル酸塩、メタンスルホン酸塩、エタンスルホン酸塩、ナフタレン-2-スルホン酸塩、フタル酸塩、サリチル酸塩、ソルビン酸塩、ステアリン酸塩、コハク酸塩、酒石酸塩、パントテン酸塩、酒石酸水素塩、及びトルエン-p-スルホン酸塩、パモエート塩からなる群より選択される、請求項1に記載の使用。
- 前記薬学的に許容される塩がHCl塩である、請求項12に記載の使用。
- 前記運動機能の障害が、統一ハンチントン病評価尺度-総運動スコア、統一ハンチントン病評価尺度-修正運動スコア、統一ハンチントン病評価尺度-舞踏病スコア、統一ハンチントン病評価尺度-ジストニアスコア、多発性硬化症ウオーキング尺度12、身体能力試験、手の動きスコア、歩行及びバランススコア、定量的運動評価、またはタイムドアップ・アンド・ゴー評価によって測定される、請求項1に記載の使用。
- 前記運動機能の障害が、高速化人差し指タッピング、回内/回外の手タッピング、把持力分析及び舞踏病分析、並びに、高速化フットタッピングを含む、請求項1に記載の使用。
- 前記機能的能力の障害、前記運動機能の障害、及び前記認知の障害は、複合統一ハンチントン病評価尺度(cUHDRS)によって測定される請求項1~15のいずれか一項に記載の使用。
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JP2023185630A JP2024016113A (ja) | 2019-06-12 | 2023-10-30 | ハンチントン病及びその症状を治療するためのプリドピジン及びその類似体を含む組成物 |
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US16/438,508 | 2019-06-12 | ||
US16/438,508 US11090297B2 (en) | 2013-06-21 | 2019-06-12 | Pridopidine for treating huntington's disease |
PCT/IL2020/050654 WO2020250234A1 (en) | 2019-06-12 | 2020-06-12 | Composition comprising pridopidine and analog thereof for treating huntington disease and symptoms thereof |
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JP2023185630A Pending JP2024016113A (ja) | 2019-06-12 | 2023-10-30 | ハンチントン病及びその症状を治療するためのプリドピジン及びその類似体を含む組成物 |
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JP2017519839A (ja) | 2014-06-30 | 2017-07-20 | テバ ファーマシューティカル インダストリーズ リミティド | プリドピジンの類似体、それらの製造および使用 |
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WO2011107583A1 (en) * | 2010-03-04 | 2011-09-09 | Nsab, Filial Af Neurosearch Sweden Ab, Sverige | Substituted 4-phenyl-n-alkyl-piperidines for preventing onset or slowing progression of neurodegenerative disorders |
US9012476B2 (en) * | 2011-12-08 | 2015-04-21 | IVAX International GmbH | Hydrobromide salt of pridopidine |
AU2013323133A1 (en) * | 2012-09-27 | 2015-05-07 | Teva Pharmaceutical Industries Ltd. | Combination of rasagiline and pridopidine for treating neurodegenerative disorders, in particular Huntington's disease |
BR112015006623A2 (pt) * | 2012-09-27 | 2017-07-04 | Teva Pharma | laquinimod e pridopidina para o tratamento de doenças neurodegenerativas |
JP2016523862A (ja) * | 2013-06-21 | 2016-08-12 | テバ・ファーマシューティカルズ・インターナショナル・ゲーエムベーハーTeva Pharmaceuticals International GmbH | ハンチントン病を治療するための高用量プリドピジンの使用 |
TW201618760A (zh) * | 2014-11-05 | 2016-06-01 | 雷普特製藥有限公司 | 使用半胱胺組合物治療亨廷頓氏病之方法 |
MX2019002265A (es) * | 2016-08-24 | 2019-10-30 | Prilenia Therapeutics Dev Ltd | Uso de pridopidina para el tratamiento de la disminucion funcional. |
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JP2017519839A (ja) | 2014-06-30 | 2017-07-20 | テバ ファーマシューティカル インダストリーズ リミティド | プリドピジンの類似体、それらの製造および使用 |
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Journal of Huntington's Disease,2018年,Vol.7,p.1-16 |
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IL288940A (en) | 2022-02-01 |
EP3982963A4 (en) | 2023-06-21 |
WO2020250234A1 (en) | 2020-12-17 |
AU2020293739A1 (en) | 2021-12-16 |
BR112021024744A2 (pt) | 2022-03-22 |
JP2022535929A (ja) | 2022-08-10 |
JP2024016113A (ja) | 2024-02-06 |
MX2021015338A (es) | 2022-01-18 |
CA3137633A1 (en) | 2020-12-17 |
AU2020293739B2 (en) | 2023-11-30 |
CL2021003312A1 (es) | 2022-08-26 |
CN113950328A (zh) | 2022-01-18 |
EP3982963A1 (en) | 2022-04-20 |
EA202193190A1 (ru) | 2022-03-24 |
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