Alteon says data from its phase 2 trial shows alagebrium improves measure of diastolic dysfunction

By E. Janene Geiss

Philadelphia, Nov. 15 - Alteon Inc. said that data from its phase 2a Pedestal trial in diastolic dysfunction demonstrated the ability of its lead A.G.E. Crosslink Breaker alagebrium to improve measures of diastolic function, including a significant reduction in left ventricular mass.

A second Phase 2a study found the compound to significantly improve endothelial function. Both studies point to

the importance of the continued development of alagebrium and A.G.E. Crosslink Breakers as a novel class of compounds that may help reduce cardiovascular risk, company officials said in a news release.

The data was presented Tuesday at the American Heart Association Scientific Sessions in Dallas.

In the diastolic dysfunction trial, known as Pedestal (Patients with Impaired Ejection Fraction and Diastolic Dysfunction: Efficacy and Safety Trial of Alagebrium), 22 patients were treated in an open-label, two dose (35 mg and 210 mg twice daily) regimen and followed by echocardiography.

The data revealed absolute improvements from a combined analysis of both dose groups in Doppler measures of diastolic function, including the early/late atrial filling phase ratio, deceleration time, isovolumetric relaxation time and concomitant reduction of left atrial pressure, officials said.

In addition, regression of left ventricular mass and left ventricular end-diastolic volume was achieved, officials said.

"Alagebrium had important benefits among patients with systolic heart failure and diastolic dysfunction. These benefits included improved measures of diastolic function, hemodynamics and cardiac remodeling. Future investigations aimed at evaluating the expected clinical improvements are warranted," Vinay Thohan, assistant professor of medicine, Methodist DeBakey Heart Center in Houston, said in the release.

Parsippany, N.J.-based Alteon is developing a new class of drugs that have shown the potential to reverse or slow down diseases of aging and complications of diabetes.

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