Anavex Life Sciences Corp. (NASDAQ:AVXL) shareholders woke up to a nice 8% pop in the value of their shares, after the drug maker 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. (Original Source)
On the ratings front, Anavex Life Sciences has been the subject of a number of recent research reports. In a report issued on October 7, Maxim analyst Jason Kolbert maintained a Buy rating on AVXL, with a price target of $15, which implies an upside of 266% from current levels. Separately, on September 29, FBR’s Christopher James reiterated a Buy rating on the stock and has a price target of $10.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Christopher James have a yearly average loss of 15.3% and 15.4% respectively. Kolbert has a success rate of 28% and is ranked #4191 out of 4271 analysts, while James has a success rate of 30% and is ranked #4171.
Anavex Life Sciences Corp. is a biopharmaceutical company. It is engaged in the discovery and development of new drugs for the treatment of neurological diseases and cancer, utilizing its proprietary drug discovery sigmaceptor platform. The company’s portfolio comprises novel, wholly owned sigma receptor agonists and antagonists.