Clinical-stage biopharmaceutical company Anavex Life Sciences Corp. is working on an investigational oral treatment for Alzheimer’s disease called ANAVEX 2-73, with full PART A data and preliminary PART B data from its ongoing Phase 2a clinical trial to be presented during the Clinical Trials on Alzheimer’s Disease (CTAD) conference, November 5 and 7 in Barcelona, Spain.
The trial’s Principal Investigator, Stephen Macfarlane, who also serves as director and associate professor at Aged Psychiatry, Caulfield Hospital in Melbourne, Australia, will represent the company and host a late-breaking oral session entitled “New Exploratory Alzheimer’s Drug ANAVEX 2-73: Assessment of Safety and Cognitive Performance in a Phase 2a Study in mild-to-moderate Alzheimer’s Patients.” During the presentation, which will take place Saturday, November 7, at 9:45 a.m. CET, at the Gran Hotel Princesa Sofia, in Barcelona, Macfarlane will focus on the the multicenter Phase 2a clinical trial of ANAVEX 2-73. The study includes two separate phases and includes 32 mild-to-moderate Alzheimer’s patients. While PART A is a simple randomized, open-label, two-period, cross-over, adaptive trial of up to 36 days, PART B is an open-label extension trial for an additional 52 weeks.
The research intends to assess the maximum dose of treatment tolerated by patients, and to explore cognitive efficacy using mini-mental state examination score (MMSE), dose response, bioavailability, Cogstate and electroencephalographic (EEG) activity, including event-related potentials (EEG/ERP), as well as the preformance of ANAVEX 2-73 as an add-on therapy to donepezil (Aricept).
ANAVEX 2-73 is Anavex’s lead investigational treatment for Alzheimer’s disease, in line with the company’s goal of finding effective therapies for Alzheimer’s disease, other central nervous system (CNS) diseases, pain, and various types of cancer. The novel drug targets sigma-1 and muscarinic receptors, which are thought to decrease the amount of protein misfolding, beta amyloid tau and inflammation through upstream actions.
Last November, the biopharmaceutical company presented encouraging results from their phase 1 clinical trial for Anavex 2-73, during the CNS Summit 2014 in Boca Raton, Florida. The phase 1 study demonstrated that the treatment is safe and well tolerated, suggesting a favorable pharmacokinetics profile. During the randomized, double-blind, placebo-controlled study no severe adverse events were registered, while the adverse events reported included moderate and reversible headache and dizziness, which are common symptoms associated with drugs that target central nervous system (CNS) conditions, such as Alzheimer’s.