Atherogenics Is Feeling the Squeeze

AGI-1067 also lowers good cholesterol, or HDL, and raises bad cholesterol, or LDL, even when patients are also taking cholesterol-lowering statins. This is a repeat finding from AGI-1067's phase II trial and is another source of concern about the drug's safety profile.

Moving to efficacy results, AGI-1067 showed no benefit whatsoever compared with the placebo on the study's primary endpoint. The hazard ratio -- a measure of risk reduction -- was 1, which means AGI-1067 and placebo had the same effect.

The p value on the primary endpoint -- the odds that the results happened by chance -- was 0.985, well above the 0.05 level required to reach statistical significance demonstrating the drug's effect.

But the efficacy of AGI-1067 did look better when Atherogenics examined some secondary efficacy endpoints. Here the drug caused a 19% reduction compared with the placebo in certain "hard" clinical endpoints, such as cardiovascular death, heart attack and stroke.

But these hard endpoints seem cherry-picked. For instance, revascularization and unstable angina -- two other hard clinical endpoints -- were excluded from the secondary analysis. The former is a particularly strange endpoint to exclude because the original rationale for AGI-1067 was as a drug that breaks down fatty deposits in arteries. If that's the way the drug works, then it should reduce the need for patients to undergo artery-opening revascularization procedures.

Atherogenics executives also were pushing the ability of AGI-1067 to reduce by 64% the time-to-development of new onset diabetes. But compared with existing diabetes drugs and some in the latter stages of development, AGI-1067's impact on diabetes appears limited. And that's before factoring in the potential toxicity issues.

In short, AGI-1067 is no tasty drink. Investors will be well-served to quench their thirst elsewhere.

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