MONTVALE, N.J., Jan. 12 /PRNewswire-FirstCall/ -- Synvista Therapeutics, Inc. (NYSE Alternext US: SYI) has completed enrollment of its BENEFICIAL study, a Phase 2 double-blind, placebo-controlled, randomized trial of the Company's compound alagebrium. The study is designed to measure the effect of alagebrium on exercise tolerance in patients with chronic systolic heart failure. In addition, the Company anticipates completing enrollment of its BREAK (Beginning a Randomized Evaluation of the A.G.E. [Advanced Glycation End Product] Breaker Alagebrium in Diastolic Heart Failure) study in the First Quarter of 2009. BREAK, a randomized, double-blind, placebo controlled study, evaluates whether alagebrium (200mg twice daily) can improve exercise tolerance, as measured by the 6-minute walk test, in patients diagnosed with diastolic heart failure.
"We are extremely pleased with the progress thus far in our clinical program for alagebrium," said Noah Berkowitz, M.D., Ph.D., President and Chief Executive Officer of Synvista Therapeutics, developer of alagebrium. "Based on our dialogue with the FDA, we believe that exercise tolerance is an approvable regulatory endpoint, in patients with systolic or diastolic heart failure. Accordingly, we look forward to the timely completion of these studies which could provide proof of efficacy and a partial basis for drug approval."
Alagebrium is Synvista's clinical candidate for interfering with A.G.E.-related sclerosis and fibrosis of the heart, kidney and other tissues leading to heart failure, diabetic nephropathy and other disorders. It is a proprietary A.G.E. crosslink breaker that is designed to function unlike any previously developed pharmaceutical agents to reverse the disease states associated with age or diabetes-related stiffening of vessels, tissues and organs. Alagebrium has completed a series of
|SOURCE Synvista Therapeutics, Inc.|
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