CNS therapeutics company Accera's AC-1204 has failed to demonstrate a positive outcome in the Phase III trial for the treatment of patients with mild-to-moderate Alzheimer's disease.
AC-1204 is a small-molecule drug compound designed to leverage the physiological ketone system in order to address the deficient glucose metabolism in Alzheimer's.
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The ketones are thought to have a potential to restore and improve neuronal metabolism, resulting in better cognition and function.
The trial results indicated that the drug did not show a statistically significant difference at week 26 when compared with placebo, as measured by the Alzheimer's disease assessment scale-cognitive subscale test (ADAS-Cog).
The double-blind, randomised, placebo-controlled, parallel-group Phase III (NOURISH AD) trial evaluated the effects of daily administration of AC-1204 in the subjects for 26 weeks.
Accera research and development vice-president Samuel Henderson said: "The formulation of the drug was changed between the Phase II and Phase III studies.
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By GlobalData"Unfortunately, this change in formulation had the unintended consequence of lowering drug levels in patients. We are confident that our newly developed formulation will provide increased exposure and allow a more conclusive test of drug efficacy."
The primary and key secondary endpoints of the trial are the measure of AC-1204 effects on memory, cognition and global function.
While the drug was found to be safe with high levels of tolerability, a detailed pharmacokinetic analysis showed that the modified formulation used in the study led to a decrease in drug plasma levels when compared to prior formulations.
