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Published on June 2, 2024

Anavex Life Sciences Phase 2 Clinical Trial of Anavex 3-71 For Schizophrenia Treatment

Anavex Life Sciences has initiated Phase 2 trials for Anavex 3-71, a clinical drug with the potential to treat all domains of schizophrenia symptoms.

Schizophrenia is a complex mental illness that impacts millions of people around the world with a range of debilitating symptoms like delusions, hallucinations, depression, and difficulties controlling thoughts, feelings, and behaviors. The disorder can be incredibly detrimental to daily life, resulting in difficulty participating in daily activities and maintaining relationships and employment.

With symptoms known to manifest uniquely in each individual, schizophrenia is notoriously among the most challenging illnesses to treat, with approximately 34% of people not responding to therapy.

Anavex Life Sciences, the clinical-stage biopharmaceutical company developing small molecule therapies for the most challenging central nervous system diseases like Alzheimer’s, Parkinson’s, and Rett, is currently at the forefront of developing an innovative therapy for schizophrenia. The company recently announced the start of its placebo-controlled Phase 2 clinical study of Anavex 3-71, an investigative drug with the potential to treat all symptom domains of schizophrenia without the typical side effects associated with antipsychotics.

“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,” said Christopher Missling, Ph.D., president and CEO. “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.”

Anavex 3-71 Schizophrenia Treatment

The symptoms of schizophrenia are often divided into three domains: positive (delusions and hallucinations, paranoia), negative (depression, social isolation, lack of speech), and cognitive (memory loss, disorganized thoughts, and attention issues), with typical treatments largely ineffective at managing all three domains of symptoms.

Following the adequate safety profile of Anavex 3-71 in Phase 1 of its clinical trial, the company has gained FDA clearance for a placebo-controlled Phase 2 trial and has begun screening patients ahead of its second-quarter start date.

“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,” stated Missling.

By synergistically modulating the two brain receptors known to enhance cognition and neurotransmission — SIGMAR1 and M1 receptors — Anavex 3-71 can potentially address schizophrenia-related disruptions to neuronal homeostasis and treat all symptoms of the disorder, revolutionizing treatment that often requires a combination of medications and a list of negative side effects.

“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. Often, available treatments are limited by side effects, e.g., movement disorders, sedation, weight gain, and other metabolic side effects,” said Missling.

Anavex 3-71 Phase 2 Clinical Trial

The Phase 2 Anavex 3-71 clinical trial will take place over two parts, and evaluate the drug’s safety, efficacy, tolerability, pharmacokinetics, and electrophysiology.

Part A will consist of a double-blind, placebo-controlled trial that will test multiple ascending doses over a 10-day period. These results will inform the dose for Part B, a second double-blind, placebo-controlled, proof-of-concept efficacy study that will take place over 28 days.

Clinical outcomes will be assessed based on the Positive and Negative Syndrome Scale for testing schizophrenia symptoms and innovative neuroinflammatory, metabolomic, transcriptomic, fluid, and electrophysiological biomarkers found clinically important for measuring the disorder.

“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,” Missling stated in a press release.

As Anavex gears up for its Phase 2 study, the company moves one step closer to validating the use of Anavex 3-71 for treating schizophrenia, a motion that will positively transform the lives of millions living with the disease.

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