Thumped by the FDA, Accera’s attempt to do a serious Alzheimer’s PhIII ends with a flop

Accera CEO Charles Stacey

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the Boulder, CO-based biotech decided to jump into serious R&D work with a therapy that could prove a claim originally made by its “medical food” product, Axona.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.

AC-1204 is a therapeutic version of its dubious brain food Axona, which is still on the market after the FDA slammed the label.

The so-called brain fuel targets the brain’s reduced ability to metabolize glucose in key areas associated with Alzheimer’s. The drug is designed to spur ketones to improve neuronal metabolism, operating on the theory that fresh fuel could restore cognitive abilities in mild to moderate patients.

Now Accera, a partner of Nestle’s, joins the long and growing list of biopharma companies to try, and fail, on Alzheimer’s.

Accera CEO Charles Stacey commented:

“The trial result is disappointing for us and the millions of patients, caregivers and physicians who urgently need new treatment options for this devastating disease. This outcome is unexpected in light of the data seen in our Phase 2 study in which patients exhibited a statistically significant improvement of greater than 3 points in ADAS-Cog.”

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