Neurochem's novel oral beta-amyloid fibrillogenesis inhibitor Alzhemed (tramiprosate) has received fast track designation from FDA, the Canadian firm announced July 24.

FDA's Division of Neurology Products has scheduled an August meeting with the firm to discuss the North American tramiprosate Phase III work the firm completed in February and get feedback on statistical models, Neurochem said.

Researchers presented preliminary Phase III data at the Alzheimer's Association International Conference on the Prevention of Dementia in Washington, D.C., June 11. However, the firm said at the time that it was adjusting the statistical model it used to analyze the results. "Accordingly, no predictions or conclusions can yet be made regarding the outcome of the Phase III study," Neurochem said.

The firm's ongoing European Phase III clinical trial for tramiprosate will discontinue patient screening in August because the trial has exceeded its original patient enrollment objectives.

Based on the outcome of the meeting with FDA, Neurochem may modify the design of the European trial, "especially with respect to statistical models," the firm said.

Neurochem has previously indicated that if approved, Alzhemed would be the first drug on the market to target the amyloid plaques characteristic of the disease and not its symptoms (¹ Also see "Neurochem/J&J’s Kiacta Action Date Extended To July 16" - Pink Sheet, 11 April, 2007.).

-Pamela Taulbee (p.taulbee@elsevier.com)

Neurochem’s Alzhemed On Fast Track For Alzheimer’s Disease

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