Synvista initiates Phase II heart failure study

Break study is a randomized, double-blind, placebo controlled study to assess the effect of six months of oral treatment with 400mg (200mg twice daily) alagebrium versus placebo in patients diagnosed with diastolic heart failure as verified by echocardiography. The trial will ultimately enroll 80 patients per cohort and be conducted in as many as 25 centers in the US.

Investigators intend that at least half of the study subjects will have diabetes mellitus. The primary efficacy measure of the study is improvement of exercise tolerance as assessed by the six-minute walk test, an accepted regulatory endpoint. In addition, there will be a number of secondary and tertiary measurements including the effect on carboxymethyllysine, a biomarker of AGE [advanced glycation end product), against which Synvista has developed a proprietary monoclonal antibody, 4G9, which can be developed into an in-vitro diagnostic test.

Noah Berkowitz, president and CEO of Synvista, said: “This is a very important study for alagebrium. By looking at the results of the Break study along with our Beneficial study in systolic heart failure, we will have a better understanding of the role of AGEs in heart failure. We look forward to seeing the results of the Break study before the end of 2009.”