Anavex Life Sciences Completes Participant Enrollment in Study
Study ANAVEX3-71-SZ-001 successfully completes enrollment with a total of 71 participants
Both Part A (16 participants) and Part B (55 participants) of the placebo-controlled Phase 2 study fully enrolled
Top line data expected in the second half of 2025
New York – Anavex Life Sciences Corp. (Nasdaq: AVXL), a pioneering biopharmaceutical company dedicated to developing groundbreaking therapies, proudly announces that it has reached full enrollment in its Phase 2 clinical study for ANAVEX®3-71 targeting schizophrenia.
This trial, designated ANAVEX3-71-SZ-001, has successfully enrolled a total of 71 participants, with the distribution of subjects being 16 in Part A and 55 in Part B. Part A explored multiple ascending doses, achieving promising preliminary safety data and stimulating EEG biomarker outcomes. Part B will take a deeper dive into the efficacy and safety of ANAVEX®3-71 over a longer treatment timeframe with a larger group of participants.
Christopher U Missling, PhD, the President and CEO of Anavex, expressed gratitude to all participants and investigators involved. He emphasized the critical unmet need for effective schizophrenia treatment options that address a broad spectrum of symptoms. Missling conveyed hope that the forthcoming results would signal a step forward in the development of ANAVEX®3-71 for those affected by schizophrenia.
ANAVEX®3-71 operates as a dual SIGMAR1 receptor agonist and M1 positive allosteric modulator. This innovative mechanism could potentially manage all schizophrenia symptom domains while minimizing the side effects commonly associated with conventional antipsychotics.
Top-line data from the trial is projected to be reported in the second half of 2025, which many stakeholders eagerly await to assess the effectiveness of this novel treatment.
Understanding Schizophrenia
Schizophrenia is a long-lasting and often debilitating mental health condition that severely impacts an individual's thoughts, emotions, and behavior. It affects nearly 24 million individuals globally, with 2.8 million residing in the U.S. The disorder is defined by three primary symptom domains: positive symptoms such as hallucinations and delusions; negative symptoms that hinder life enjoyment and social engagement; and cognitive impairments affecting memory, concentration, and decision-making.
Due to the inadequacies of existing treatments, many individuals with schizophrenia face significant challenges in maintaining employment, living independently, and sustaining healthy relationships. Current therapies may help alleviate specific symptoms, yet approximately 34% of patients do not respond positively to treatment, while an additional 50-60% experience only partial symptom relief or troublesome side effects.
About Anavex Life Sciences
Anavex Life Sciences Corp. (NASDAQ: AVXL) operates as a publicly traded biopharmaceutical entity committed to innovating therapeutic solutions for a diverse range of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders. This includes efforts focused on Alzheimer's disease, Parkinson's disease, schizophrenia, Rett syndrome, and other central nervous system conditions.
Anavex's lead candidate, ANAVEX®2-73 (blarcamesine), has successfully navigated a Phase 2a and a Phase 2b/3 trial for Alzheimer's disease, alongside multiple studies addressing Parkinson's disease dementia and Rett syndrome in various patient groups. By targeting SIGMAR1 and muscarinic receptors, ANAVEX®2-73 aims to restore cellular homeostasis, with preclinical evidence indicating its potential to halt or reverse Alzheimer's disease progression. Moreover, ANAVEX®3-71 has shown promising preclinical results, benefiting mitochondrial function and mitigating neuroinflammation.
Contact Information
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: andrew@barwicki.com
Frequently Asked Questions
What is the purpose of the ANAVEX®3-71 study?
The study seeks to evaluate the efficacy and safety of ANAVEX®3-71 in treating schizophrenia.
How many participants are involved in the study?
The study has enrolled a total of 71 participants.
When can we expect results from the study?
Top-line results are expected to be reported in the second half of 2025.
What is Anavex Life Sciences focused on?
Anavex focuses on developing innovative treatments for neurodegenerative and neurodevelopmental disorders.
What are the implications of ANAVEX®3-71's mechanism of action?
This mechanism could potentially treat all symptom domains of schizophrenia without traditional medication side effects.
