Anavex Life Sciences Corp. (“Anavex” or the “Company”) (OTCQX: AVXL) today announced enrollment of the first patient in a multicenter Phase 2a clinical trial for ANAVEX 2-73, which is being evaluated for the treatment of Alzheimer’s disease. The randomized trial is designed to assess the safety and exploratory efficacy of ANAVEX 2-73 alone as well as in combination with donepezil (ANAVEX PLUS) in patients with mild to moderate Alzheimer’s disease. ANAVEX 2-73 targets sigma-1 and muscarinic receptors, which have been shown in preclinical studies to reduce stress levels in the brain and to reverse the pathological hallmarks observed in Alzheimer’s disease. ANAVEX 2-73 showed no serious adverse events in a previously performed Phase 1 study.
The Principal Investigator for the trial is Stephen Macfarlane, Director and Associate Professor, Aged Psychiatry, Caulfield Hospital in Melbourne, Australia.
“Current treatments for Alzheimer’s only address symptoms of the disease, while data from preclinical studies of ANAVEX 2-73 demonstrated the potential to directly address the pathology of Alzheimer’s disease,” said Christopher U. Missling, PhD, President and Chief Executive Officer for Anavex. “We hope that ANAVEX 2-73 and our combination compound ANAVEX PLUS will offer an effective and well-tolerated treatment option for those afflicted with Alzheimer’s disease, and we are excited to start the Phase 2a clinical trial.”
Today, Alzheimer’s disease remains the largest unmet medical need in neurology. More than 25 million people are currently diagnosed with Alzheimer’s, with the associated cost of care estimated to exceed $200 billion annually. By 2050, the disease is expected to afflict 100 million. Alzheimer’s disease is a neurological disorder generally characterized by memory loss and cognitive decline. A neurodegenerative form of dementia, the disease begins with mild symptoms and becomes progressively worse.
About the Phase 2a Trial of ANAVEX 2-73 and ANAVEX PLUS
The multicenter Phase 2a trial of ANAVEX 2-73 and ANAVEX PLUS is designed as an initial dose finding study of up to 36 days with an open-label extension study for an additional 26 weeks. The primary objective is to evaluate the maximum tolerated dose of ANAVEX 2-73 with ongoing administration in 32 mild to moderate Alzheimer’s patients. The open-label extension study is planned to establish a longer drug effect for patients who continue on an oral daily dose. The trial is expected to enroll patients at up to seven clinical sites in Melbourne, Australia. 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.