Boulder, Colorado-based Accera has completed enrollment for its Phase 3 NOURISH AD clinical trial of AC-1204 for the treatment of mild to moderate Alzheimer’s disease (AD). Top-line data should be reported later this year.
AC-1204 is an orally administered therapy with the potential to improve dementia patients’ cognition and daily functioning. The treatment works by inducing a mild state of ketosis, thereby providing an alternative energy source to the brain. AC-1204 potentially has a number of favorable properties as a product candidate for dementia, including once-daily dosing, a low potential for drug interactions, and a long history of safe use.
NOURISH AD is a 26-week, double-blind, randomized, placebo-controlled, parallel-group Phase 3 clinical trial to investigate the effects of daily administration of AC-1204 in participants with mild to moderate AD with an optional 26-week open label extension.
The primary and secondary endpoints will assess the effect of AC-1204 in the cognition and memory as measured by the Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) and the effects of the drug on patients’ global function as measured by the Alzheimer’s Disease Study Cooperative Study – Clinical Global Impression of Change (ADCS-CGIC).
Data from this trial will inform the design of a second pivotal Phase 3 trial, compulsory for regulatory approval of the drug, which Accera is planning to start early next year.
“Accera is one of a few companies that will report Phase 3 clinical results in Alzheimer’s in 2016,” Dr. Charles Stacey, the company’s president and CEO, said in a recent press release. “Positive Phase 3 data will provide further clinical validation of targeting the metabolic deficit that is known to be characteristic of Alzheimer’s disease. Furthermore, it will build on the impressive efficacy data we obtained in our Phase 2b study.”
Results from the Phase 2b trial showed that compared to placebo, treatment with AC-1204 improved cognition and memory (measured by the ADAS-Cog) in greater than 3 points in patients with mild to moderate AD who did not carry the epsilon 4 variant of the apolipoprotein E gene (APOE4),
“Physicians need new treatment options; we believe that our drug candidate has the potential to become an integral part of the armamentarium for use in treating mild to moderate Alzheimer’s disease,” Stacey added.