ANAVEX3-71 previously displayed an adequate safety profile in a Phase I trial involving healthy subjects. Credit: BlurryMe / Shutterstock.

US-based biopharmaceutical company Anavex Life Sciences has begun a Phase II clinical trial of ANAVEX3-71, a treatment candidate for schizophrenia.

The ANAVEX3-71-SZ-001 trial recently received clearance from the US Food and Drug Administration (FDA), with the first patient having been screened ahead of time.

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The two-part, placebo-controlled trial is designed to assess the safety, tolerability, efficacy, pharmacokinetics and electrophysiology of ANAVEX3-71.

Part A is a double-blind, placebo-controlled trial with multiple ascending doses. The results from Part A will inform the selection of an appropriate dose for Part B, a proof-of-concept efficacy trial.

Participants in both segments of the trial will receive dosing for either ten or 28 days for Parts A and B respectively.

The trial will use the Positive and Negative Syndrome Scale (PANSS) and innovative fluid and electrophysiological biomarkers to measure clinical outcomes.

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ANAVEX3-71’s unique mechanism of action, as a dual SIGMAR1 receptor agonist and M1 positive allosteric modulator with agonistic effects, offers a new approach to treating schizophrenia.

The modulation of both SIGMAR1 and M1 receptors by ANAVEX3-71 could potentially correct disruptions to neuronal homeostasis seen in schizophrenia patients, targeting areas beyond the reach of current standard of care therapeutics.

Anavex Life Sciences president and CEO Christopher Missling said: “Initiating our Phase II trial of ANAVEX3-71 in schizophrenia ahead of schedule is a testament to the hard work and dedication of our clinical study team.

“Following on from our positive initial Phase I results in healthy volunteers, our Phase II study will apply novel neuroinflammatory, metabolomic and transcriptomic biomarkers at the intersection of schizophrenia pathophysiology and ANAVEX3-71’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 (ANAVEX2-73) onto a regulatory pathway for potential treatment of Alzheimer’s disease.”