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Fixed dose combinations comprising ETC1002 and one or more statins for treating or reducing cardiovascular risk

A fixed-dose technology of ETC-1002, which is used in the field of fixed-dose combinations containing ETC1002 and or multiple statins for the treatment or reduction of cardiovascular risk, and can solve problems such as negative side effects

Pending Publication Date: 2018-01-02
ЕСПЕРІОН ТЕРАПЕУТІКС ІНК
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Unfortunately, these drugs can also cause negative side effects

Method used

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  • Fixed dose combinations comprising ETC1002 and one or more statins for treating or reducing cardiovascular risk
  • Fixed dose combinations comprising ETC1002 and one or more statins for treating or reducing cardiovascular risk
  • Fixed dose combinations comprising ETC1002 and one or more statins for treating or reducing cardiovascular risk

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0130] 1. List of abbreviations and definitions of terms

[0131] The following abbreviations and technical terms are used in this research protocol.

[0132] Table 2: Abbreviations and technical terms

[0133]

[0134]

[0135]

[0136]

[0137] ETC-1002 background

[0138] Mechanism of action

[0139] ETC-1002 is a small molecule inhibitor of adenosine triphosphate (ATP)-citrate lyase (ACL), adenosine triphosphate (ATP)-citrate lyase (ACL) is the hydroxymethylglutaryl coenzyme A (HMG) in the cholesterol biosynthesis pathway. -CoA) Enzyme upstream of reductase (molecular target of statins). ETC-1002 can regulate the competitive inhibition of ACL. Inhibition of ACL can reduce cholesterol synthesis in the liver, resulting in increased LDLR expression and increased clearance of LDL particles in the blood. Therefore, ETC-1002 inhibits ACL through the same route as statins inhibit HMG CoA reductase.

[0140] An important distinguishing feature of ETC-1002 is that, unlike statins, it cann...

Embodiment 2

[0175] ETC-1002 / High-dose statin fixed-dose combination

[0176] In patients treated with statin drugs, when ETC-1002 180mg was added to a stable atorvastatin 80mg background therapy for 28 days, the efficacy of ETC-1002 180mg in reducing LDL-C relative to placebo was evaluated.

[0177] The multi-dose plasma PK of atorvastatin 80 mg and its active metabolite, o-hydroxyatorvastatin, and p-hydroxyatorvastatin alone or in combination with 180 mg of steady-state ETC-1002 was evaluated.

[0178] The inventor expects that this add-on therapy is at least as effective as previous studies and produces the same or better safety / tolerability.

[0179] Without wishing to be bound by theory, the inventor believes that when administered with a stable high-dose statin (atorvastatin 80 mg), the ETC-1002 180-mg tablet provides additional benefits compared to atorvastatin alone. LDL-C reduces efficacy and is safe and tolerable in adult patients treated with statins. The combination ETC-1002 will show...

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PUM

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Abstract

Disclosed herein are compositions comprising fixed doses of ETC-1002 and one or more statins. Also disclosed herein are methods for using fixed doses of ETC-1002 and one or more statins. Uses includemethods of treating cardiovascular disease or reducing the risk of cardiovascular disease in a subject. Uses also include methods of treating hypercholesterolemia in a subject.

Description

[0001] Cross references to related applications [0002] This application claims the benefits of U.S. Provisional Application No. 62 / 133,739 filed on March 16, 2015 and U.S. Provisional Application No. 62 / 277,403 filed on January 11, 2016, each of which is incorporated herein by reference in its entirety. Into. Technical field [0003] This application relates to methods and compositions useful for treating or reducing the risk of cardiovascular conditions. Statins are the cornerstone of the prevention and treatment of cardiovascular diseases. However, in the United States and other countries in the world, cardiovascular diseases are still one of the main causes of death. In the United States alone, millions of people suffer from cardiovascular diseases or disorders. Background technique [0004] Low-density lipoprotein cholesterol (LDL-C) is an established risk factor for cardiovascular disease. However, many patients, such as those with hypercholesterolemia, cannot reduce LDL-C...

Claims

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Application Information

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IPC IPC(8): A61K31/194A61P9/10A61P3/06
CPCA61K31/505A61K31/366A61K31/22A61K31/405A61K31/47A61P9/00A61P3/06A61K45/06A61K31/194A61K2300/00A61K31/40A61K31/20A61P43/00A61P9/10A61K31/225A61K31/35
Inventor 罗格·斯科菲尔德·牛顿诺厄·拉班·罗森贝格黛安娜·伊莱恩·麦克杜格尔
Owner ЕСПЕРІОН ТЕРАПЕУТІКС ІНК
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