Anavex Life Sciences Announces 12-Month Data of ANAVEX 2-73 in a Phase 2a Study in Mild-to-Moderate Alzheimer’s Disease Pat...
Source: GlobeNewswire Inc.?
Data presentation at CTAD 2016
Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq:AVXL) today announced a positive 57-week update from its Phase 2a study in mild-to-moderate Alzheimer’s disease (AD) patients for ANAVEX 2-73, which targets cellular homeostasis. The study met both primary and secondary endpoints.
At 57 weeks, Alzheimer’s patients taking a daily oral dose between 10mg and 50mg, ANAVEX 2-73 was well tolerated. There were no clinically significant treatment-related adverse events and no serious adverse events.
Published AD studies confirmed substantial declines of cognitive (MMSE) and functional (ADCS-ADL) measures as well as Cogstate and EEG/ERP over 12 month in similar AD populations. Pre-specified exploratory analyses of the current study included the cognitive (MMSE) and the functional (ADCS-ADL) as well as Cogstate, HAM-D and EEG/ERP changes from baseline.
Specifically, in comparison to historical control from a pooled placebo arm cohort study conducted by the Alzheimer Disease Cooperative Study Group in mild-to-moderate AD patients of comparable ages and MMSE baselines, over 12 month the ANAVEX 2-73 data shows a calculated treatment benefit of 1.8 points on the MMSE scale (p<0.016) and a calculated treatment benefit of 4 points on the ADCS-ADL score (p<0.019). Furthermore, the correlation was positive with all measured scores (MMSE, ADCS-ADL, Cogstate, HAM-D and EEG/ERP).
George Perry, PhD, Dean and Professor at the University of Texas at San Antonio and Editor-in Chief of the Journal of Alzheimer’s Disease, commented, “In addition to the very encouraging results, which point to the therapeutic potential of targeting cellular homeostasis in a complex CNS disease like Alzheimer’s, this trial has been intelligently designed as a highly informative study, looking unprejudiced at all potential relationships and hence allowing to learn from all correlations of the now available pool of data, in order to execute subsequent trials with much more relevant information at hand.”
Despite non-optimized dosing of ANAVEX 2-73 throughout the 12-month study, continued significant improvements from baseline of cognitive, functional and behavioral scores in a group of patients were observed, respectively. This data will be analyzed using refined mathematical modeling methods in conjunction with the detailed pharmacokinetic (PK) information.
“Alzheimer’s disease is a progressive neurodegenerative disease that causes problems with memory, thinking and behavior. Currently available treatments cannot stop Alzheimer's from progressing; they can only temporarily slow the worsening of dementia symptoms,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. "We believe this data gives us a solid foundation from which to continue the next phase of rationally designed clinical trials. Anavex is grateful for the dedication of the patients, their families and the clinical investigators who participated in this study."
The Company is presenting findings from the study at the Clinical Trials on Alzheimer's Disease (CTAD) meeting on Saturday, December 10th at 8:45 a.m. PT in the oral communication session. The presentation will be available in the publications section of the Anavex website.
The Company will also conduct a conference call with the investment community in conjunction with the upcoming financial year-end 2016 report.
