Anavex Life Sciences Corp. (NASDAQ: AVXL) is engaged as a clinical-stage biopharmaceutical company, which is focused on the research and development of innovative therapeutics to treat neurodegenerative disorders such as Alzheimer’s, Parkinson’s, Rett Syndrome and more. Shares of the biopharma company are rallying 38% through early trading on Friday, December 2, 2022. Over the past three months, Anavex Life Sciences has seen average daily volume of 1.04 million shares. However, volume of 35.27 million shares or dollar volume of around $428.53 million, has already exchanged hands through early trading.
Shares of Anavex Life Sciences are gaining after the company announced results from its Phase 2b/3 clinical trial of ANAVEX2-73 for the treatment of mild cognitive impairment (MCI) from early stages of Alzheimer’s disease. The clinical trial results showed the drug candidate met primary and key secondary endpoints, which were determined from meaningful improvements in cognitive function as measured by ADAS-Cog, ADCS-ADL, and CDR-SB. The company says the next step is to meet with the FDA to discuss the clinical data and work on commercialization.
ANAVEX2-73 is an orally-administered, small-molecule activator of the sigma-1 receptor, which has shown the capability of restoring neural cell homeostasis and promoting of neuroplasticity. The Phase 2b/3 trial was a randomized, double-blind, multicenter, placebo-controlled study that enrolled 509 patients for the treatment of early Alzheimer’s disease over the course of 48 weeks.
In the trial, patients that were treated with ANAVEX2-73 were 84% more likely to have improved cognitive abilities as measured by ADAS-Cog score change of -0.50 or better from the baseline to the end of treatment when compared to the placebo group. On average, patients who saw improvements while taking the drug candidate saw an average ASAS-Cog cognition score of -4.03 points. This shows ANAVEX2-73 was 167% more effective in improving cognitive abilities compared to the placebo group.
“People living with Alzheimer’s disease desperately need new therapies and I am truly impressed with the outcome of this study, which demonstrated reversal of cognitive decline,” said A/Professor Stephen Macfarlane, FRANZCP, Head of Clinical Services at the Dementia Centre, HammondCare and Principal Investigator. “These results complement and are consistent with findings from the previously completed Alzheimer’s disease Phase 2a ANAVEX®2-73 trial, which also demonstrated therapeutic effect on cognition and function. ANAVEX®2-73 might be a very much needed solution for many patients with Alzheimer’s disease.”
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