Accera Blames Alzheimer’s Clinical Trial Failure on Low Uptake of Oral Drug AC-1204

Accera Blames Alzheimer’s Clinical Trial Failure on Low Uptake of Oral Drug AC-1204
Yet another Alzheimer’s disease clinical trial (NCT01741194) has ended in disappointment. Accera, noting that its Phase 3 trial of AC-1204 showed the drug offered no benefits over placebo, blamed its failure on an inadequate uptake of AC-1204 into the bloodstream. "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,” said President and CEO Charles Stacey, MD. "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." AC-1204 targets brain energy metabolism. By providing neurons with energy in the form of ketones — a type of molecule that acts as fuel when glucose is in short supply — Accera believes the oral drug can improve cognitive impairment. But after 26 weeks of treatment, there were no differences in the Alzheimer's disease Assessment Scale-Cognitive Subscale test (ADAS-Cog) between patients treated with AC-1204 and those receiving placebo. The drug formulation — that is, the composition of the tablet, was changed between the earlier Phase 2 study and the current trial. This resulted in an unintentional lowering of drug levels in patients' bloodstream, which Accera says is why the trials failed. “We are conf
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