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Alzheon's Reclaimed Alzheimer's Drug Has Potential To Win Big – If History Doesn't Repeat

 
• By Lucie Ellis-Taitt

New data for Alzheon's Alzheimer's disease drug, tramiprosate, from two Phase III trials that failed to show efficacy in 2007 may shed light on how the company can better design new trials for follow-on product ALZ-801, for which it will initiate pivotal Phase III studies next year.

Alzheon Inc. has published updated analyses from two failed 2007 Phase III studies for Alzheimer's therapy tramiprosate, providing details it hopes will help guide an improved version of the compound, ALZ-801, through pivotal late-stage trials and sequential regulatory filings. However, this new subgroup analysis has raised concerns and highlighted possible pitfalls for future studies of Alzheon's up-cycled therapy.

Tramiprosate's ill-fated Phase III program included two similarly designed, 78-week trials in patients with mild-to-moderate Alzheimer's disease. The North American...

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