The FDA agreed with an external safety monitoring panel that Alteon Inc. should end one of its three Phase III trials of pimagedine for diabetes, and the company said it would discontinue that study while proceeding with the other two."Obviously, we're disappointed," said Kenneth Moch, chief financial officer of Ramsey, N.J.-based Alteon. "But we're moving ahead with alacrity, so we'll see."Pimagedine is designed to inhibit formation of advanced glycosylation end products (AGE) by preventing glucose from binding to proteins in the blood. Diabetic patients are prone to high levels of AGE as a result of excess blood glucose. Accumulation of AGE can damage kidneys, blood vessels and nerves.The halted study, called ACTION II, was testing pimagedine in Type II diabetics with progressive kidney disease. The continuing trial, ACTION I, evaluates pimagedine in Type I diabetics with the same disease. (See BioWorld Today, March 20, 1998, p. 1.)"Type II is a larger market, but a higher percentage of Type Is develop kidney disease," Moch said.When news broke last week of the safety panel's recommendation, Alteon's stock (NASDAQ:ALTN) dropped 50 percent, ending the day at $4.937. The company's shares closed Monday at $5.125, up $0.312.A third Phase III trial, studying the drug in end-stage renal disease diabetics, also is ongoing, after an independent panel's review earlier this month. — Randall Osborne

No Comments