Anavex Life Sciences has commenced the 30mg dose step in its ongoing phase I clinical trial to evaluate ANAVEX 2-73, a drug candidate for Alzheimer's disease. This is the third of six potential dose steps and follows the successful completion of the 1mg and 10mg dosing rounds. There have been no adverse effects recorded to date.
Trial participants are receiving single, ascending oral doses of ANAVEX 2-73 with one group potentially advancing to a maximum single oral dose of 240mg.
Positive safety data at lower doses has enabled the company to increase the amount being administered by 10 times, from 1mg to 10mg. This recommendation was unanimously recommended by the Safety Review Committee for ANAVEX 2-73. Each volunteer is also contacted by phone for a further safety check on day seven following drug administration.
Data from the phase I trial is expected to build upon the safety profile of ANAVEX 2-73 in pre-clinical studies conducted with mice, rats and dogs. Pre-clinical studies of ANAVEX 2-73 have already generated evidence of improving and reversing the memory and learning deficits in animal models which may mimic the effects of Alzheimer's disease. There is evidence of 'neuroprotection'—certain brain cells that are ordinarily lost in these animal models are preserved.
The primary objective of the phase I clinical trial is to evaluate the safety and tolerability of ANAVEX 2-73 in humans for the first time. The secondary objective of the phase I trial is to determine the pharmacokinetic profile of single oral ascending doses of ANAVEX 2-73.