Anavex Life Sciences Corp. has completed enrollment in its Phase 2 clinical trial (ANAVEX3-71-SZ-001) of ANAVEX®3-71 for schizophrenia treatment. The study enrolled 71 participants across two parts: Part A (16 participants) focused on multiple ascending doses, while Part B (55 participants) involves a longer treatment duration for more comprehensive data. Top-line data is anticipated in the latter half of 2025.
This successful enrollment signifies a crucial step in advancing a potential new treatment for schizophrenia, a debilitating mental illness affecting millions globally. Current therapies often fall short, leaving many patients with inadequate symptom control or facing intolerable side effects. ANAVEX®3-71, acting as a dual SIGMAR1 receptor agonist and M1 positive allosteric modulator, offers a novel mechanism of action that could potentially target all symptom domains of schizophrenia, addressing a significant unmet medical need. Positive initial safety and EEG biomarker data from Part A further heighten the importance of this trial.
Part B of the trial will yield crucial clinical and biomarker information regarding ANAVEX®3-71’s efficacy and safety. The completion of enrollment allows the study to progress towards generating pivotal results that could validate the drug’s potential. Previous research indicates that ANAVEX®3-71 has shown promise in preclinical models by positively impacting mitochondrial dysfunction and neuroinflammation, both implicated in schizophrenia’s pathology.
The forthcoming data from this Phase 2 trial will be critical for determining the next steps in ANAVEX®3-71’s development. Positive results could pave the way for larger-scale Phase 3 trials and potentially bring a much-needed, novel therapeutic option to individuals living with schizophrenia. This development also reinforces the growing interest in exploring innovative mechanisms of action to address this complex disorder, potentially shifting the treatment landscape.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
