Metabasis Reports Positive Results From Phase Ib Hypercholesterolemia Trial
Posted on: Friday, 20 June 2008, 12:00 CDT
Metabasis Therapeutics has announced the results of its 14-day, Phase Ib multiple-dose clinical trial in subjects with mild hypercholesterolemia, which showed that MB07811 was safe and well tolerated across the seven doses tested, ranging from 0.25mg up to 40mg.
No differences in heart rate, heart rhythm or blood pressure were observed between MB07811 and placebo-treated patients. Mild increases in liver enzymes were observed at the higher doses of MB07811 along with dose-related mean shifts in thyroid hormone levels.
The clinical trial results also showed dose-related reductions in fasting low-density lipoprotein cholesterol (LDL-C) and fasting triglyceride (TG) levels at day 14. Significant placebo-adjusted LDL-C reductions from baseline were observed at doses of 5mg and above and ranged from approximately 15 - 41%, while placebo-adjusted TG levels were reduced by more than 30% at doses of 2.5mg and above.
This completed Phase Ib clinical trial was a randomized, double-blind, placebo-controlled, rising multiple-dose study that enrolled 56 subjects with a mean baseline LDL-C of 126mg/dL and a mean baseline TG of 118mg/dL. Subjects received either placebo or MB07811 at an oral dose of 0.25mg, 1mg, 2.5mg, 5mg, 10mg, 20mg or 40mg.
MB07811 is a novel, orally administered, beta-subtype-selective thyroid hormone receptor agonist that is designed to target the liver in order to avoid or minimize well known side effects of thyroid hormone receptor (TR) agonists.
Howard Foyt, vice president of clinical development at Metabasis, said: "The results of this clinical trial provide evidence that MB07811 is capable of significantly lowering both LDL-C and TG levels in patients with mild hypercholesterolemia without affecting heart rate, heart rhythm or blood pressure."
Source: Datamonitor
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