Alzheon Moving Alzheimer’s Drug Into Phase 3

Alzheon says it is moving its Alzheimer’s disease drug candidate (ALZ-801) into a pivotal Phase 3 program after reporting positive results from two Phase 1b studies. ALZ-801 is an optimized prodrug of tramiprosate, according to the company.

The Phase 1b study results demonstrated “favorable gastrointestinal tolerability, consistent and sustained plasma levels, and allowed selection of an ALZ-801 clinical dose that is bioequivalent to the tramiprosate dose that showed promising efficacy in prior Phase 3 trials,” Alzheon says. “Our body of ALZ-801 data and analyses suggest a well-differentiated and potentially transformative Alzheimer’s medicine: an oral tablet that targets the underlying amyloid pathology in Alzheimer’s, with compelling clinical efficacy in patients who are apolipoprotein E4 carriers,” it says. The Phase 3 study should begin in early 2017.