Glimmer of hope for pimagedine
It's usually futile to turn secondary end points into primary end points when a compound has failed its first set of pivotal trials. But Alteon Inc. thinks the effort is worth a shot for its pimagedine inhibitor of advanced glycosylation end products (A.G.E.s) in Type I diabetes, based on new knowledge about the role of proteinuria in kidney disease.
The company's original Phase III ACTION I study failed to meet its primary end point of reducing the risk of doubling serum creatinine (see BioCentury, Nov. 23, 1998). ALTN now hopes to run a new Phase III study to treat the progression of kidney disease in patients with Type I diabetes. The primary end point would be proteinuria, which was a secondary end point that showed statistical significance in the company's Phase III ACTION I trial...