By COLLEEN CREAMER
For VerusMed
Karo Bio AB’s eprotirome, an investigational, liver-selective, thyroid hormone receptor agonist, appears to significantly lower serum LDL cholesterol, triglycerides and lipoprotein(a) in patients with dyslipidemia when administered with Merck/Schering-Plough Pharmaceuticals’ cholesterol absorption inhibitor Zetia (ezetimibe), based on data from a 10-week, Phase IIb study.
The double-blind, placebo-controlled, dose-ranging study included 109 patients who were receiving a stable dose of Zetia 10 mg/day. The patients were randomized to receive eprotirome once daily at a dose of 25 mcg, 50 mcg or 100 mcg. The purpose of the study was to assess whether the combination of eprotirome and Zetia might serve as a substitute for statin therapy.
Topline data showed a statistically significant lowering of LDL cholesterol ranging from 15 percent to 25 percent beyond that achieved with Zetia therapy. The authors noted that these results are in line with findings from previous monotherapy and statin combination studies.
Eprotirome also induced a clinically relevant lowering of serum LDL cholesterol, triglycerides and lipoprotein(a). Further, the drug was found to be safe and well-tolerated.
In previous Phase II studies, eprotirome, taken alone or in combination with statins, led to significant lowering of LDL cholesterol in patients with dyslipidemia and significantly reduced other risk factors for the development of cardiovascular disease, Karo Bio noted.
Per Olof Wallstrom, president of Karo Bio, noted that a total of 391 patients have been treated in three consecutive Phase II studies and that the data “are consistent and robust.”
“For the dose range 25 mcg to 100 mcg per day of eprotirome we observed reduction in serum LDL cholesterol from 14 percent to 26 percent, reduction of triglycerides from 23 percent to 44 percent and reduction of lipoprotein(a) from 22 percent to 39 percent,” Wallstrom said.
