AEGR-733 monotherapy or combination therapy with ezetimibe significantly reduces low-density lipoprotein cholesterol levels by four weeks of beginning therapy, according to a presentation of phase II study results at the annual meeting of the American Heart Association.

The presentation reported interim results from an ongoing phase II clinical trial. In the study, the combination of 10 mg dose ezetimibe and 5 mg AEGR-733 resulted in a reduction of 35 percent after 4 weeks compared with a 20-percent reduction for ezetimibe alone.

There was no difference in discontinuation rates between the two groups. In addition, treatment with both 5 mg and 7.5 mg doses of AEGR 733 were shown to be effective as monotherapy (mean reductions of 19 percent and 28 percent, respectively).

"These results are a demonstration of the potential broad applicability of AEGR-733 in treatment as a monotherapy and in combination with current lipid lowering therapies," commented Fredrick F. Samaha, MD, Associate Professor of Medicine, University of Pennsylvania School of Medicine and the principal investigator for this study. "There is a clear unmet medical need in the management of hypercholesterolemia and this class of compounds, known as microsomal triglyceride transfer protein inhibitors (MTP-inhibitors), has the potential to play an important role as treatment patterns continue to evolve in the direction of combination therapy."

Final study results for the current trial are expected in the first quarter of 2007. The manufacturer plans to initiate several additional Phase II trials in early 2007, including one that will examine low-density cholesterol lowering efficacy of various doses of AEGR 733 used in combination with atorvastatin versus agents used as monotherapy.