Diabetic Kidney Disease

Speedel stops SPP301 phase 3 trial in diabetic kidney disease

Published in Health Business Week, February 2nd, 2007

Speedel (SPPN) announced that, in the interests of patient safety, it has stopped the current pivotal phase 3 clinical trial of SPP301 (avosentan) in diabetic nephropathy (diabetic kidney disease).

This decision was taken by the Ascend trial's steering committee based on a recommendation from the Data Safety Monitoring Board to stop the trial, following a significant imbalance in fluid retention in patients among the study arms. The company is informing health authorities including the U.S. Food and Drug Administration (FDA) and is in the process of notifying all clinical investigators in the trial.

The company also said that the compound will be...

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Source: Health Business Week (2007-02-02)

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