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HDL Mimetic Reduces Atherosclerosis in Phase II Study
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     Esperion Therapeutics, Inc. on Thursday said its investigational lipid drug ETC-216 produced a statistically significant regression of atherosclerosis, according to initial results of a placebo-controlled phase II trial involving 47 patients with acute coronary syndromes (ACS).

    In a press release, the company explains that ETC-216 is an ApoA-I Milano/phospholipid complex. ApoA-I Milano (AIM) has been identified as an apolipoprotein variant associated with "paradoxically low levels of HDL-cholesterol" and reduced cardiovascular risk, "presumably due to enhanced reverse lipid transport." A human recombinant AIM protein complexed with a phospholipid acts as an HDL mimetic.
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    Principal investigator Dr. Steven Nissen of The Cleveland Clinic Foundation led the multicenter trial, in which patients with coronary artery disease were randomized to placebo or one of two doses of ETC-216 (15 or 45 mg/kg) infused every seventh day for a maximum of five treatments.

    Coronary plaque size was measured by intravascular ultrasound before and after treatment. The primary endpoint of the trial was the change in percent atheroma volume for evaluable patients in the combined ETC-216 treatment arms when compared to end-of-treatment values.
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    Esperion President and CEO Roger Newton emphasized in a conference call that the statistically significant change seen in plaque size was based on the difference between baseline and completion of therapy, not relative to changes in the placebo arm. He declined to say if the placebo arm also experienced a reduction in plaque volume.

    Esperion said it would publish full results of the study at a medical conference or in peer-reviewed journal before the end of the year.
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    "ETC-216 demonstrated it could mobilize cholesterol and enhance the function of HDL," said Newton, who helped discover and develop Pfizer, Inc.’s top-selling cholesterol drug Lipitor when he worked at the company. "When we publish the findings, additional intravascular ultrasound data will shed light on how the drug will change the vascular biology of the plaque."

    Company officials, who have spent careers in atherosclerosis research, conceded in the conference call that they were surprised at such strong results after only four weeks of treatment.
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    "This is a generational advance," said Esperion Chief Medical Officer Dr. Adeoye Olykotun, who joined the company three weeks ago and has researched cardiovascular disease for 25 years. "I thought the drug would have a significant impact, but not the dramatic effect we observed earlier this week."

    Dr. Olykotun said the company would address plans for a phase III trial in the next few months., 百拇医药