First Patient Screened Ahead of Schedule in Phase 2 Clinical Trial of Therapeutic Candidate for Schizophrenia

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The first patient in a placebo-controlled, phase 2 clinical study of Anavex®3-71 for the treatment of the positive, negative, and cognitive domains of schizophrenia has been screened ahead of schedule.¹ The therapeutic candidate was approved by the US Food and Drug Administration (FDA) to initiate phase 2 studies in the second quarter of 2024 in January, after it demonstrated an adequate safety profile in a phase 1 clinical trial in healthy volunteers.²

“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,” said Christopher U. Missling, PhD, president and chief executive officer of Anavex®3-71 developer Anavex Life Sciences Corp, in a press release.

“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 disease.”

Anavex®3-71’s differentiated mechanism is a dual SIGMAR1 receptor agonist and M1 positive allosteric modulator with agonistic effects. 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 adverse effects of standard-of-care antipsychotics.¹

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.¹

The placebo-controlled, phase 2, in-patient trial, ANAVEX®3-71-SZ-001 (NCT06245213),³ will investigate the effects of ANAVEX®3-71 in patients with schizophrenia in 2 parts. Part A is a double-blind, placebo-controlled, multiple ascending dose trial. The results of Part A will be used to select a dose for Part B, a proof-of-concept efficacy, double-blind, placebo-controlled trial. Participants will undergo either 10 or 28 days of dosing in Part A and Part B, respectively. And standard clinical outcome measures, including the Positive and Negative Syndrome Scale (PANSS), and novel fluid and electrophysiological biomarkers will be assessed.¹

Anavex is leveraging several advances in electroencephalography/event-related potential (EEG/ERP) biomarkers in schizophrenia developed in collaboration with the industry-led ERP Biomarker Qualification Consortium. This includes a validated and automated data analysis pipeline for quantitative EEG and ERP biomarkers, as well as normative EEG/ERP data in patients with schizophrenia and matched healthy volunteers. These advances also include recently established relationships between EEG/ERP biomarkers and clinically important measures in schizophrenia.¹

Stay up-to-date on news related to research on promising new interventions and developments in the treatment of a wide variety of psychiatric disorders at psychiatrictimes.com.

Note: This article was prepared with the assistance of ChatGPT.

References

1. Anavex Life Sciences initiates placebo-controlled U.S. phase 2 clinical trial of ANAVEX®3-71 in schizophrenia. Anavex Life Sciences. News release. March 18, 2024. Accessed March 20, 2024. https://www.anavex.com/post/anavex-life-sciences-initiates-placebo-controlled-u-s-phase-2-clinical-trial-of-anavex-3-71-in-schi

2. O’Brien E. Drug candidate for schizophrenia, Alzheimer disease approved to initiate phase 2 trial in Q2 2024. Psychiatric Times. January 25, 2024. Accessed March 20, 2024. https://www.psychiatrictimes.com/view/drug-candidate-for-schizophrenia-alzheimer-disease-approved-to-initiate-phase-2-trial-in-q2-2024

3. A study of ANAVEX3-71 in adults with schizophrenia (SZ-001). ClinicalTrials.gov. Updated February 7, 2024. Accessed March 20, 2024. https://clinicaltrials.gov/study/NCT06245213?term=ANAVEX3-71&rank=2