US-based biopharmaceutical firm Anavex Life Sciences has received regulatory approval from the Ethics Committee in Australia to start a Phase IIa clinical trial of its proprietary compounds, ANAVEX 2-73 and ANAVEX PLUS, in patients with Alzheimer’s disease.
ANAVEX PLUS is the combination of ANAVEX 2-73 and donepezil (Aricept) and is claimed to have produced up to 80% greater reversal of memory loss in Alzheimer’s disease models versus when the drugs were used individually.
ANAVEX 2-73 targets sigma-1 and muscarinic receptors, which have been shown in preclinical trials to reduce stress levels in the brain and to reverse the pathological hallmarks observed in this disease.
The company will now start patient screening and enrolment in the Phase IIa trial, with results expected to be reported in 2015.
The randomised trial will enrol 32 mild to moderate Alzheimer’s disease patients at up to seven sites.
According to the company, its adaptive design stipulates that data be collected at a number of intervals, including at three and six months.
The trial’s key endpoints include bioavailability, dose finding and dose response, cognitive efficacy, and the relationship of ANAVEX 2-73 as a potential effective add-on therapy to donepezil, the current standard of care.
Anavex president and chief executive officer Christopher Missling said: "The company’s innovative trial design allows us to capture and maximise key information about ANAVEX 2-73 in the most efficient way.
"This is an exciting time for our company given the properties of ANAVEX 2-73 and the vast unmet medical needs for Alzheimer’s disease."
The company said that the preclinical data indicates that ANAVEX 2-73 has the potential to prevent, halt and/or reverse the course of Alzheimer’s disease. It has also been observed to have a highly encouraging synergistic effect between ANAVEX 2-73 and donepezil (Aricept).