New York – January 12, 2015 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (OTCQX: AVXL) today announced dosing of the first patient in the Phase 2a clinical trial of ANAVEX 2-73 and ANAVEX PLUS, which are being developed as an oral therapy and oral drug combination for the potential treatment of Alzheimer’s disease. In preclinical studies, ANAVEX 2-73 was shown to prevent, halt and/or reverse Alzheimer’s disease by targeting sigma-1 and muscarinic receptors. The drug therapeutic showed no serious adverse events in a successfully completed Phase 1 human study.
“Dosing the first patient is an exciting milestone for Anavex and we plan to report the topline results of this Phase 2a study by the third quarter of 2015,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “With its adaptive design, the aim of this trial is to objectively measure all possible effects of the drug in patients, which serves to optimally design and reduce the risk for future pivotal trials. There is an urgent, unmet need in Alzheimer’s disease, with a new case developing every 67 seconds and 5.2 million Americans currently diagnosed. We believe ANAVEX 2-73 and ANAVEX PLUS may effectively address this unmet need as potential symptomatic and possibly disease-modifying Alzheimer’s therapies.”
In this multicenter Phase 2a adaptive clinical trial of ANAVEX 2-73 and ANAVEX PLUS, at least 32 mild to moderate Alzheimer’s patients will be enrolled and they will be able to receive the study drug for up to 26 weeks. The primary objective of the trial is to evaluate the maximum tolerated dose of ANAVEX 2-73 in these patients. Additional trial objectives include dose response, bioavailability, cognitive efficacy and the relationship of ANAVEX 2-73 as an add-on therapy to donepezil, the current standard of care. Additional information regarding the trial is available from the U.S. National Institutes of Health (NIH) clinical trials database at www.clinicaltrials.gov.
About ANAVEX 2-73 and ANAVEX PLUS
ANAVEX 2-73 is an orally available small molecule being investigated for the treatment of Alzheimer’s disease. In addition to preclinical data indicating that ANAVEX 2-73 has the potential to prevent, halt and/or reverse the course of Alzheimer’s disease, there was a highly encouraging synergistic effect observed between ANAVEX 2-73 and donepezil (Aricept®). The combined therapeutic, called ANAVEX PLUS, produced up to 80% greater reversal of memory loss in Alzheimer’s disease models versus when the drugs were used individually.