Anavex Life Sciences Corp., a clinical stage biopharmaceutical company developing novel drug candidates to treat Alzheimer's, diseases of the central nervous system (CNS) and various types of cancer, has announced that a report in the current issue of peer-reviewed International Pharmaceutical Industry Journal ("IPI Journal") predicts that ANAVEX 2-73 will have a meaningful effect in Alzheimer's disease based on the Alzheimer's Disease Assessment Scale-Cognitive ("ADAS-Cog"), especially when combined with donepezil (Aricept®), the world's best-selling Alzheimer's drug. The Company believes this drug combination, called ANAVEX PLUS, is a compelling commercial opportunity because of its potential to treat symptoms of Alzheimer's while also possibly modifying or reversing the course of the disease. A Phase 1b/2a clinical trial of ANAVEX PLUS, is scheduled to begin mid 2014.
The findings, utilizing a predictive humanized calibrated cortical cognitive model for Alzheimer's Disease in, which was focusing on symptomatic effects based on the M2 antagonistic target engagement level of ANAVEX 2-73, predict that ANAVEX PLUS, combining ANAVEX 2-73 with low dose (5mg) donepezil (Aricept®), will show a significantly improved clinical outcome versus when the drugs are administered individually. ANAVEX PLUS is expected to show up to 9 points improvement in ADAS-Cog at 12 weeks and 6 points at 26 weeks in mild-to-moderate Alzheimer's patients, respectively, at target engagement levels of approximately 70%. When administered alone, ANAVEX 2-73 is expected to improve ADAS-Cog by 5 points at 12 weeks, and 3 point at 26 weeks, which is also likely to be detected clinically. As a point of reference, in human clinical trials 5 mg donepezil (Aricept®) was reported to show an average improvement of 3.6 points ADAS-Cog at 12 weeks and 2.6 at 26 weeks, respectively.
"This data, as reported in IPI Journal, confirms the strong synergy we have previously seen preclinically between ANAVEX 2-73 and donepezil. It also supports the advancement of ANAVEX PLUS into a Phase 1b/2a trial," said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. "The same type of computer model is in use by big pharmaceutical companies to predict the difference between rodent and human brains as well as the anticipated clinical trial outcome. Therefore, the computer simulation model is believed to have reduced the trial risk for ANAVEX PLUS."
The report, entitled "The Anticipated Clinical Effect of the new Alzheimer Drug ANAVEX PLUS in a Predictive Humanized Cortical Cognitive Model for Alzheimer's Disease," was co-authored by Drs. Missling, Maurice and Geerts, Chief Scientific Officer of In Silico BioSciences (ISB) and Adjunct Professor at the School of Medicine at the University of Pennsylvania, along with industry colleagues.