November 7, 2008
Aegerion Presents Positive Results From Phase II Studies of Dyslipidemia Drug
Aegerion Pharmaceuticals, a biopharmaceutical company engaged in the treatment of cardiovascular and metabolic disease, has announced positive top-line data from three separate Phase II trials involving its lead cholesterol management compound, AEGR-733, which is a microsomal triglyceride transfer protein inhibitor.
All three trials were designed to evaluate the efficacy, safety and tolerability of low doses of AEGR-733 alone and in combination with other lipid lowering agents such as Lipitor, Zetia and fenofibrate.
Preliminary data from the trials indicates statistically significant reductions in patients' low-density-lipoprotein cholesterol (LDL-C) versus baseline, while at the same time suggesting a promising safety and tolerability profile, including low levels of hepatic fat accumulation.
The three Phase II trials ranged in duration from eight to 12 weeks and collected clinical data on more than 460 patients who suffer from dyslipidemia, a condition in which there are abnormal lipid levels in the bloodstream. During the trials, AEGR-733 was administered alone as a once-daily pill in doses ranging from 2.5mg to 10mg and also in combination with other lipid lowering agents.
At the high end of the dose range evaluated in these Phase II trials, the drug reduced LDL-C in patients up to 35% from baseline when used as a monotherapy, and up to 66% from baseline when administered in combination with Lipitor. In addition to reducing LDL-C, patients also experienced a reduction in their triglyceride levels by up to 50% and weight loss of up to 3% after 12 weeks on therapy.
The trials also suggested a promising safety and tolerability profile. In one of the trials, which was designed to evaluate patients' hepatic fat levels while treated with AEGR-733 alone and in combination with Lipitor, Zetia and fenofibrate, the average hepatic fat levels after 12 weeks of exposure across doses of AEGR-733 ranging from 2.5 to 10mg were approximately 7% with no arm exceeding 10%. This preliminary data compares favorably to what the company believes are the relevant clinical benchmarks for hepatic fat.
Bill Sasiela, chief medical officer of Aegerion Pharmaceuticals, said: "We are pleased with the results of these trials because they suggest the ability of AEGR-733 at low doses to significantly reduce LDL cholesterol and triglycerides with what we believe to be an acceptable safety and tolerability profile.
"We hope to confirm and extend these observations in our Phase III studies and believe that AEGR-733 could become an important part of the treatment regimen for dyslipidemic patients who have limited treatment options today."