Metabasis Announces Promising Results from its Phase 1b Clinical Trial for Treatment of Hyperlipidemia
News Jun 24, 2008
Metabasis Therapeutics, Inc. has announced the results of its 14-day, Phase 1b 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 0.25 mg up to 40 mg.
There were no serious adverse events, and the frequency of adverse events in MB07811-treated subjects was similar to placebo-treated subjects. 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 5 mg and above and ranged from approximately 15 - 41%, while placebo-adjusted TG levels were reduced by more than 30% at doses of 2.5 mg and above.
This completed Phase 1b clinical trial was a randomized, double-blind, placebo-controlled, rising multiple-dose study that enrolled 56 subjects with a mean baseline LDL-C of 126 mg/dL and a mean baseline TG of 118 mg/dL.
Subjects received either placebo or MB07811 at an oral dose of 0.25 mg, 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg or 40 mg. MB07811 is a novel, orally administered, beta-subtype-selective thyroid hormone receptor (TRß) agonist that is designed to target the liver in order to avoid or minimize well known side effects of thyroid hormone receptor (TR) agonists.