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ANAVEX3-71-002 trial achieved its primary endpoint demonstrating safety and tolerability in both male and female adults
Oral ANAVEX®3-71 tablet exhibits superior pharmacokinetics compared to the current immediate-release oral capsule, enabling once-daily dosing
NEW YORK, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. ("Anavex" or the "Company") (NASDAQ:AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced successful development of a once-daily oral tablet formulation for the ANAVEX®3-71 program. The once-daily modified-release oral tablet exhibits superior pharmacokinetics compared to the current immediate-release oral capsule, enabling once-daily dosing. This achievement was confirmed in a Phase 1b clinical trial comparing the two dosage forms (ANAVEX3-71-002 trial).
The completed open-label, randomized study evaluated the pharmacokinetics and safety of immediate- and modified release formulations of ANAVEX®3-71 administered orally in healthy male and female adults 18 years or older. Study results demonstrated a pharmacokinetic profile supportive of once-daily dosing with a safety profile consistent with prior ANAVEX®3-71 studies.
ANAVEX®3-71 (formerly AF710B) is a dual SIGMAR1 receptor agonist and M1 positive allosteric modulator with agonistic effects. ANAVEX®3-71 has previously been studied in healthy volunteers prior to study ANAVEX3-71-002 and the Phase 2 study ANAVEX3-71-SZ-001. This novel mechanism of action offers the potential to treat all symptom domains (positive, negative, and cognitive) of schizophrenia without the side effects of standard of care antipsychotics.
Posted In: AVXL
