Anavex announces U.S phase 2 trial of ANAVEX 3-71

Anavex Life Sciences announced the initiation of the U.S. FDA cleared placebo-controlled Phase 2 trial of ANAVEX3-71 for the treatment of schizophrenia, which is expected to begin in Q2 2024. ANAVEX3-71 positive initial Phase 1 results in healthy volunteers were previously reported. The placebo-controlled Phase 2 ANAVEX3-71-SZ-001 study, will consist of two-parts to explore multiple ascending doses in individuals with schizophrenia followed by a 28-day treatment period in a larger cohort. The study will utilize standard clinical outcome measures for schizophrenia including the Positive and Negative Symptoms Scale and novel electrophysiological biomarkers identified by the ERP Biomarker Qualification Consortium for use in schizophrenia clinical trials. “Schizophrenia is a serious mental illness affecting 24 million people worldwide. While current antipsychotic therapies can be effective in managing positive symptoms, like hallucinations and delusions, they may not fully address persistent negative symptoms or cognitive difficulties. Often, available treatments are limited by side effects, e.g., movement disorders, sedation, weight gain, and other metabolic side effects,” said Christopher Missling, PhD, President and Chief Executive Officer of Anavex. “We are excited to build on our diverse Precision Medicine Platform, which advanced blarcamesine onto a regulatory pathway for potential treatment of Alzheimer’s disease and to now also study ANAVEX3-71, another small molecule from our drug portfolio with selective SIGMAR1 receptor activity as a novel pharmacological approach to potentially provide a new schizophrenia treatment option for patients and their physicians.”