Anavex Life Sciences has reported the upcoming commencement of a Phase II clinical trial of its drug candidate, ANAVEX 3-71, aimed at treating schizophrenia.

The trial, which has received clearance from the US Food and Drug Administration (FDA), is expected to commence in the second quarter of 2024.

ANAVEX 3-71, previously known as AF710B, acts as a dual sigma non-opioid intracellular receptor 1 (SIGMAR1) receptor agonist and M1 positive allosteric modulator.

The placebo-controlled Phase II study, dubbed ANAVEX 3-71-SZ-001, will be conducted in two parts.

It will initially analyse various ascending doses of the drug in schizophrenia patients, followed by a treatment period of 28 days in a bigger cohort.

The study’s design includes the use of standard clinical outcome measures for schizophrenia, such as the Positive and Negative Symptoms Scale (PANSS), and new electrophysiological biomarkers.

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By GlobalData

These biomarkers were detected by the ERP Biomarker Qualification Consortium for their potential use in trials for schizophrenia.

The unique mechanism of action of ANAVEX 3-71 is believed to offer a comprehensive treatment option for all symptom domains of schizophrenia, positive, negative, and cognitive while also alleviating the side effects associated with standard antipsychotic medications.

Anavex president and CEO Christopher Missling said: “Schizophrenia is a serious mental illness affecting 24 million people worldwide.

“While current antipsychotic therapies can be effective in managing positive symptoms, like hallucinations and delusions, they may not fully address persistent negative symptoms or cognitive difficulties.

“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’s disease, and to now also study ANAVEX 3-71, another small molecule from our drug portfolio with selective SIGMAR1 receptor activity, as a novel pharmacological approach to potentially provide a new schizophrenia treatment option for patients and their physicians.”

In September 2023, the company reported follow-on analysis data from a Phase IIb/III study of ANAVEX 2-73 for Alzheimer’s disease.