Anavex Reports Predicted Clinical Effect for ANAVEX 2-73 in Computer Simulation Model of AD

Anavex Life Sciences Corp. has presented new data from a study evaluating ANAVEX 2-73 in a computer simulation model of Alzheimer’s disease (AD) limited to symptomatic effects, which was presented during a poster session at the CNS Summit 2013 on Saturday, November 16th, 2013 in Boca Raton, Florida.

The results from the poster, entitled, “The anticipated clinical effect of the new Alzheimer drug ANAVEX 2-73 in a calibrated Quantitative Systems Pharmacology Platform”, predict that ANAVEX 2-73, in a realistic cortical network computer model of AD, will show a clinical dose-dependent improvement in AD Assessment Scale - Cognitive (ADAS-Cog) of 2-3 points at 12 weeks, which is similar to Aricept® (donepezil), currently the best-selling Alzheimer’s drug with reported sales of $4 billion last year.

However, when combining ANAVEX 2-73 with low dose (5mg) Aricept® (donepezil), the clinical outcome significantly improves, to a maximal effect of anticipated ADAS-Cog response of 6-7 points at 12 weeks and 4.5-5.5 points at 26 weeks in mild-to-moderate AD patients, respectively. These improvements suggest the effects will likely be clinically detectable and meaningful.

Tangui Maurice, PhD, CNRS Research Director at the University of Montpellier and INSERM, said, “This data confirms the significant and unexpected synergy we have previously seen between ANAVEX 2-73 and Aricept® (donepezil) in a preclinical model. This result allows us to confidently move forward into the analysis of this potentially promising combination drug for Alzheimer’s disease.”

Hugo Geerts, PhD, Chief Scientific Officer of In Silico BioSciences (ISB) and Adjunct Professor at the School of Medicine at the University of Pennsylvania, stated, “We don't have many examples of blinded predictions using our Quantitative Systems Pharmacology platform, only three so far, however, in those three cases the respective sponsor performed a clinical trial that essentially confirmed our unexpected quantitative predictions, and the respective outcomes were published.”

Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, said, “The data is quite encouraging since the study focused purely on symptomatic effects and no sigma-1 effect was implemented or considered. With this study we added another layer of positive evidence to advance ANAVEX 2-73 in combination with donepezil into clinical trials.”