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 confident that our newly developed formulation will provide increased exposure and allow a more conclusive test of drug efficacy,” said Samuel Henderson, PhD, Accera’s vice-president of research and development. Development at Accera.
Despite its drawback, Accera claims the study analysis supports the treatment hypothesis and provides valuable information for future studies of the compound.
“We are grateful for the time and effort of the patients, caregivers and investigators who participated in this study, said Michael Gold, MD, Accera’s senior medical advisor. “Accera remains committed to its work in Alzheimer’s disease with the goal of developing an effective drug for patients. We are now finalizing our clinical development plan and will engage with the FDA to confirm our proposed path forward.”
Accera will present its study’s full results in July at the Alzheimer’s Association International Conference in London.