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Treatment of severe hypertriglyceridemia

A technology for hypertriglyceridemia and hyperlipoproteinemia, which is applied in the field of treatment of severe hypertriglyceridemia, and can solve intractable and unreachable problems

Inactive Publication Date: 2017-03-01
CYMABAY THERAPETICS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0012] No drug has been shown to be effective in the treatment of type I hyperlipoproteinemia (LPL deficiency); and, despite the available treatments described above, including an appropriate (low-fat) diet, some patients with SHTG, especially those with type I or patients with type V hyperlipoproteinemia who remain refractory (ie, they are unable to achieve TG levels less than 1000 mg / dL, such as less than 10 mM, despite dietary changes and one or more of the above-mentioned therapy)
[0013] A gene replacement therapy for LPL deficiency, alipogene tiparvovec (GLYBERA), has been developed and approved in Europe (as an orphan drug) in 2012, but not yet in the US

Method used

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  • Treatment of severe hypertriglyceridemia

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Embodiment

[0061] This study is a 12-week interventional, open-label (single-blind), dose-escalation study using adult subjects (eg 30, preferably at least a quarter with type I hyperlipoproteinemia hyperlipoproteinemia and at least one quarter with type V hyperlipoproteinemia) with severe hypertriglyceridemia (fasting TG level of at least 1000 mg / dL) on stable therapy (fibrate, niacin, O3FA) or refractory to this therapy. Exclusion criteria included stage 3 or 4 heart failure, uncontrolled diabetes in the month before screening, use of corticosteroids in the month before screening, estrogen therapy (contraception or hormone replacement) (unless stable dose during the previous 2 months), pancreatic history during the 6-month period prior to screening, and current harvesting therapy. Subjects were assessed for fasting TG and other lipids at baseline. Subjects initially received 50 mg / day (when calculated as free acid) of MBX-8025 or MBX-8025 salt orally as a single daily dose for four w...

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Abstract

Treatment of severe hypertriglyceridemia, such as Type I or Type V hyperlipoproteinemia, by therapy with MBX-8025 or an MBX-8025 salt, alone or in combination with one or more of a fibrate, niacin, and an omega-3 fatty acid, optionally accompanied by apheresis.

Description

technical field [0001] The present invention relates to the treatment of severe hypertriglyceridemia. Background technique [0002] severe hypertriglyceridemia [0003] Dyslipidemia is the presence of abnormal amounts of lipids (eg cholesterol and / or fats) in the blood. In developed countries, most dyslipidemia is hyperlipidemia, ie, an increase in lipids / lipoproteins in the blood - the term hyperlipidemia is often used to include hyperlipoproteinemia. Hyperlipidemia includes hypercholesterolemia (elevated cholesterol) and hyperglyceridemia (elevated glycerides), where hypertriglyceridemia (HTG, elevated triglycerides) esters (TG)) as a subset of hyperglyceridemia. Berglund et al., "Evaluation and Treatment of Hypertriglyceridemia: AnEndocrine Society Clinical Practice Guideline", J.Clin.Endocrinol.Metab., 97(9), 2969-2989 (2012) Severe hypertriglyceridemia (SHTG) Defined as referring to serum TG levels greater than 1000 mg / dL, and very severe hypertriglyceridemia was de...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/09A61K31/192A61K31/202A61K31/4406A61P3/06
CPCA61K31/09A61K31/192A61K31/202A61K31/4406A61K2300/00A61P3/06A61P43/00A61K31/4192
Inventor 波尔·布德崔允祯罗伯特·L·马丁查尔斯·A·麦克沃特
Owner CYMABAY THERAPETICS INC
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