VIA Pharmaceuticals Announces Positive Results of Phase 2 Studies of VIA-2291 in Patients With Serious Cardiovascul... (to the brain and to reduce the risk of s...)

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VIA Pharmaceuticals Announces Positive Results of Phase 2 Studies of VIA-2291 in Patients With Serious Cardiovascular Disease

Date:11/9/2008

to the brain and to reduce the risk of stroke in patients with significant blockage in the artery. Patients in the study were treated for 12 weeks with either 100 mg of VIA-2291 or placebo, and then underwent a CEA procedure. The CEA trial was designed to provide direct evaluation of VIA- 2291's effect on inflammation by analyzing plaque removed from the carotid arteries of patients treated with VIA-2291 or placebo. The trial also measured serum biomarkers of inflammation to measure reduction in inflammation in treated patients.

Study Results

--Leukotriene Inhibition

The ACS trial demonstrated a statistically significant, dose-dependent inhibition of ex vivo stimulated LTB4 production at 12 weeks. LTB4 production was measured at trough, just before the next dose of VIA-2291 was taken, indicating a sustained pharmacological effect of the drug between doses. The secondary endpoint of change from baseline in urine Leukotriene E4 (LTE4), also showed significant inhibition at all dose levels.

The CEA trial confirmed the findings of statistically significant inhibition in leukotriene production observed in the ACS trial. In the CEA trial, LTB4 production was highly inhibited at 12 weeks (p < 0.001).

Leukotriene inhibition was seen early in both trials and was already highly significant after two weeks of drug treatment, the first time it was assessed after starting drug.

--hs-CRP Reduction

In the ACS trial, a statistically significant reduction from baseline as compared with placebo was observed in high-sensitivity C-reactive protein (hs- CRP) levels in the highest dose group of patients treated for 24 weeks. Significant reductions in hs-CRP levels were not observed in the ACS trial in patients treated for 12 weeks, perhaps due, in part, to variability in the level of hs-CRP at the baseline as a result of the recent heart attack or unstable angina.

In the CEA trial, a statistically significant reductio
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