Thumped by the FDA, Accera’s attempt to do a serious Alzheimer’s PhIII ends with a flop
A couple of years after Accera fell afoul of the FDA for its “false and misleading” label for a brain food product marketed as a treatment for Alzheimer’s, the Boulder, CO-based biotech decided to jump into serious R&D work with a therapy that could prove a claim originally made by its “medical food” product, Axona.
It didn’t work.
Today the company says that its Phase III of AC-1204 failed to separate significantly from a placebo, based on an ADAS-Cog rating after 26 weeks of treatment. Company execs, though, pinned the failure on a change in formulation between Phase II and Phase III, which they say reduced plasma levels of the therapy and left it too weak to register an impact on cognition and memory.
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