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12:00 AM
Nov 10, 2003
 |  BioCentury  |  Product Development

Lots of logic; few benchmarks

Esperion Therapeutics Inc. has shown in a Phase II trial that its ETC-216 significantly reduces plaque volume from baseline in acute coronary syndrome (ACS) patients. The next step will be to prove that this has clinical significance. But patients and investors will have to wait a long time to find out, as ESPR doesn't plan to start Phase III trials until 2005.

For ETC-216, a variant of apolipoprotein A-1 HDL, the logic is clear: The role of natural HDL is to transport cholesterol to the liver for clearance, and lowering cholesterol should reduce plaque. In theory, giving an HDL mimetic, such as ETC-216, should do the same thing.

But there are no data on the clinical benefits of such a strategy. Nor are there any published data on whether using intravascular ultrasound (IVUS) to measure reductions in...

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