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Highlights
- ANAVEX®3-71 demonstrated safety and tolerability in adults with schizophrenia.
- Biomarker trends suggest potential disease-modifying effects of ANAVEX®3-71.
- No serious treatment-emergent adverse events reported in Phase 2 study.
Anavex Life Sciences Corp. (Nasdaq:AVXL), a clinical-stage biopharmaceutical company, announced topline results from its placebo-controlled Phase 2 clinical trial of ANAVEX®3-71 for schizophrenia in adults on stable antipsychotic therapy (ANAVEX3-71-SZ-001, NCT06245213).
The study met its primary endpoint, showing that ANAVEX®3-71 was safe and well-tolerated. The safety profile aligned with prior studies in healthy volunteers, with no serious or severe treatment-emergent adverse events (TEAEs) reported in either Part A or Part B of the trial. In Part B, 2 participants on placebo discontinued due to TEAEs, while no discontinuations occurred in the ANAVEX®3-71 treatment arm.
Adverse Event Overview
- Part A: TEAEs were reported in 16.7% of participants receiving 30mg ANAVEX®3-71, with no serious events or discontinuations.
- Part B: TEAEs occurred in 39.3% of participants receiving 60mg ANAVEX®3-71 versus 48.1% for placebo, with no serious events or deaths.
Biomarker Findings
Secondary and exploratory analyses showed positive trends in electroencephalography (EEG) and event-related potential (ERP) biomarkers of schizophrenia. Neuroinflammatory biomarker assessments indicated a reduction in glial fibrillary acidic protein (GFAP) among participants receiving ANAVEX®3-71 compared to placebo. GFAP is associated with astrocyte reactivity in neuropsychiatric and neurodegenerative disorders, suggesting a potential disease-modifying effect that may increase with longer treatment.
Management Statements
Christopher U Missling, PhD, President and CEO, added, “The positive safety profile and encouraging biomarker trends support the continued development of ANAVEX®3-71 as a potential treatment for CNS disorders that could address underlying pathophysiology beyond symptomatic control.”
About ANAVEX®3-71
ANAVEX®3-71 (formerly AF710B) is a dual SIGMAR1 receptor agonist and M1 positive allosteric modulator. The compound has been evaluated in healthy volunteers and offers potential to treat positive, negative, and cognitive symptoms of schizophrenia without typical antipsychotic side effects.
About Schizophrenia
Schizophrenia affects nearly 24 million people worldwide and includes positive, negative, and cognitive symptom domains. Current treatments often leave patients with partial symptom relief or unacceptable side effects.
About Anavex Life Sciences
Anavex Life Sciences develops therapeutics for neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer’s, Parkinson’s, schizophrenia, and Rett syndrome. The company’s pipeline includes ANAVEX®2-73 and ANAVEX®3-71, targeting SIGMAR1 and muscarinic receptors to address disease pathology.
