Anavex Life Sciences Initiates Placebo-Controlled U.S. Phase 2 Clinical Trial of ANAVEX®3-71 in Schizophrenia

Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative, neurodevelopmental, and psychiatric disorders, including Alzheimer’s disease, Parkinson’s disease, Rett syndrome, schizophrenia, and other central nervous system (CNS) diseases, today announced that the first patient in its U.S. FDA cleared placebo-controlled Phase 2 clinical study of ANAVEX^®3-71 for the treatment of schizophrenia has been screened ahead of schedule.

“Initiating our Phase 2 trial of ANAVEX^®3-71 in schizophrenia ahead of schedule is a testament to the hard work and dedication of our clinical study team,” stated Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “Schizophrenia is a challenging disorder that can impair social and occupational functions and overall quality of life for the nearly 24 million people affected worldwide. Following on from our positive initial Phase 1 results in healthy volunteers, our Phase 2 study will apply novel neuroinflammatory, metabolomic, and transcriptomic biomarkers at the intersection of schizophrenia pathophysiology and ANAVEX^®3-71’s novel, dual mechanism of action, with the goal of addressing the large unmet need in this patient population. We are excited to build on our diverse Precision Medicine Platform, which advanced blarcamesine (ANAVEX^®2-73) onto a regulatory pathway for potential treatment of Alzheimer’s disease.”

ANAVEX^®3-71’s differentiated mechanism is a dual SIGMAR1 receptor agonist and M1 positive allosteric modulator with agonistic effects.^1,2 This novel mechanism of action offers the potential to treat all symptom domains of schizophrenia — positive symptoms (hallucinations and delusions), negative symptoms (difficulty enjoying life and withdrawal from others), and cognitive impairment (deficits in memory, concentration, and decision-making) — without the side effects of standard of care antipsychotics, which do not adequately address all symptom domains in schizophrenia. ANAVEX^®3-71’s ability to modulate both SIGMAR1 and M1 receptors is expected to potentially address disruptions to neuronal homeostasis observed in individuals with schizophrenia, upstream of the targets leveraged by standard of care medications.

Preceding this study, ANAVEX^®3-71 demonstrated an adequate safety profile in a Phase 1 trial in healthy volunteers.^3,4