Anavex Life Sciences Announces Full Enrollment of Phase 2 Study of 础狈础痴贰齿庐3-71 for the Treatment of Schizophrenia
Anavex Life Sciences (NASDAQ: AVXL) has completed enrollment in its Phase 2 clinical study of 础狈础痴贰齿庐3-71 for schizophrenia treatment. The study (ANAVEX3-71-SZ-001) enrolled 71 total participants across two parts: Part A (16 participants) studying multiple ascending doses, and Part B (55 participants) for longer treatment duration. Part A has been completed with encouraging preliminary safety and EEG biomarker results.
础狈础痴贰齿庐3-71 is an oral dual SIGMAR1 receptor agonist and M1 positive allosteric modulator, designed to potentially treat all schizophrenia symptom domains without standard antipsychotic side effects. The company expects to report top-line data in the second half of 2025.
Anavex Life Sciences (NASDAQ: AVXL) ha completato l'arruolamento nel suo studio clinico di Fase 2 sul 础狈础痴贰齿庐3-71 per il trattamento della schizofrenia. Lo studio (ANAVEX3-71-SZ-001) ha coinvolto 71 partecipanti totali suddivisi in due parti: Parte A (16 partecipanti) dedicata allo studio di dosi ascendenti multiple, e Parte B (55 partecipanti) per una durata di trattamento pi霉 lunga. La Parte A 猫 stata completata con risultati preliminari incoraggianti riguardo la sicurezza e i biomarcatori EEG.
础狈础痴贰齿庐3-71 猫 un agonista orale duale del recettore SIGMAR1 e modulatore allosterico positivo M1, progettato per trattare potenzialmente tutti i domini sintomatici della schizofrenia senza gli effetti collaterali tipici degli antipsicotici standard. L'azienda prevede di comunicare i risultati principali nella seconda met脿 del 2025.
Anavex Life Sciences (NASDAQ: AVXL) ha completado la inscripci贸n en su estudio cl铆nico de Fase 2 sobre 础狈础痴贰齿庐3-71 para el tratamiento de la esquizofrenia. El estudio (ANAVEX3-71-SZ-001) incluy贸 a 71 participantes en total divididos en dos partes: Parte A (16 participantes) para estudiar dosis ascendentes m煤ltiples, y Parte B (55 participantes) para un tratamiento de mayor duraci贸n. La Parte A se ha completado con resultados preliminares alentadores en cuanto a seguridad y biomarcadores EEG.
础狈础痴贰齿庐3-71 es un agonista oral dual del receptor SIGMAR1 y modulador alost茅rico positivo M1, dise帽ado para tratar potencialmente todos los dominios sintom谩ticos de la esquizofrenia sin los efectos secundarios t铆picos de los antipsic贸ticos est谩ndar. La compa帽铆a espera reportar los datos principales en la segunda mitad de 2025.
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Anavex Life Sciences (NASDAQ : AVXL) a termin茅 le recrutement de son 茅tude clinique de phase 2 sur 础狈础痴贰齿庐3-71 pour le traitement de la schizophr茅nie. L'茅tude (ANAVEX3-71-SZ-001) a inclus 71 participants au total r茅partis en deux parties : Partie A (16 participants) 茅tudiant des doses ascendantes multiples, et Partie B (55 participants) pour une dur茅e de traitement plus longue. La Partie A est termin茅e avec des r茅sultats pr茅liminaires encourageants concernant la s茅curit茅 et les biomarqueurs EEG.
础狈础痴贰齿庐3-71 est un agoniste oral double du r茅cepteur SIGMAR1 et un modulateur allost茅rique positif M1, con莽u pour potentiellement traiter tous les domaines symptomatiques de la schizophr茅nie sans les effets secondaires habituels des antipsychotiques standards. L'entreprise pr茅voit de communiquer les donn茅es principales au second semestre 2025.
Anavex Life Sciences (NASDAQ: AVXL) hat die Rekrutierung f眉r seine Phase-2-Studie zu 础狈础痴贰齿庐3-71 zur Behandlung von Schizophrenie abgeschlossen. Die Studie (ANAVEX3-71-SZ-001) umfasste insgesamt 71 Teilnehmer in zwei Teilen: Teil A (16 Teilnehmer) zur Untersuchung mehrfach ansteigender Dosierungen und Teil B (55 Teilnehmer) f眉r eine l盲ngere Behandlungsdauer. Teil A wurde mit vielversprechenden vorl盲ufigen Sicherheits- und EEG-Biomarker-Ergebnissen abgeschlossen.
础狈础痴贰齿庐3-71 ist ein oraler dualer SIGMAR1-Rezeptor-Agonist und positiver allosterischer M1-Modulator, der entwickelt wurde, um potenziell alle Symptome der Schizophrenie ohne die typischen Nebenwirkungen herk枚mmlicher Antipsychotika zu behandeln. Das Unternehmen erwartet, Topline-Daten in der zweiten H盲lfte des Jahres 2025 zu ver枚ffentlichen.
- Successfully completed enrollment for Phase 2 trial with 71 participants
- Part A showed encouraging preliminary safety and EEG biomarker results
- Novel mechanism of action potentially addressing all schizophrenia symptoms without standard side effects
- None.
Insights
Anavex completes Phase 2 enrollment for schizophrenia drug with novel mechanism; data coming in H2 2025.
The completion of enrollment in Anavex's Phase 2 clinical study of 础狈础痴贰齿庐3-71 for schizophrenia represents a significant operational milestone. With all 71 participants now enrolled across both study parts, the company has successfully executed this stage of their clinical development plan, positioning them for their data readout in H2 2025.
The two-part study design follows standard drug development methodology - Part A (16 participants) established safety parameters through multiple ascending doses, while the larger Part B (55 participants) will generate more comprehensive clinical and biomarker data. Management notes Part A demonstrated "encouraging preliminary safety and EEG biomarker results," suggesting a favorable initial profile, though without specific metrics.
The truly distinctive aspect of 础狈础痴贰齿庐3-71 is its novel dual mechanism as both a SIGMAR1 receptor agonist and M1 positive allosteric modulator. This approach differentiates it from traditional antipsychotics, which primarily target dopamine D2 receptors. Current schizophrenia treatments often inadequately address negative symptoms (social withdrawal, anhedonia) and cognitive deficits while causing problematic side effects like extrapyramidal symptoms, metabolic issues, and sedation.
This enrollment completion represents expected progression rather than a fundamental value inflection. The critical catalyst remains the topline data expected in late 2025, which will determine whether this compound advances to pivotal studies. The schizophrenia program demonstrates Anavex's strategy to leverage their SIGMAR1 platform across multiple CNS disorders beyond their more advanced Alzheimer's and Rett syndrome programs.
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, May 01, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced the successful completion of enrollment in its Phase 2 clinical study of ANAVEX庐3-71 for the treatment of schizophrenia (ANAVEX3-71-SZ-001, ).
The study has enrolled a total of 71 participants, with 16 participants in Part A and 55 participants in Part B. Part A of the study, which investigated multiple ascending doses, has been completed with encouraging preliminary safety and electroencephalography (EEG) biomarker results previously reported. Part B, which includes more participants and a longer treatment duration, will provide more comprehensive clinical and biomarker data on the efficacy and safety of ANAVEX庐3-71 in individuals with schizophrenia.
鈥淲e are pleased to announce the full enrollment of our ANAVEX3-71-SZ-001 study and would like to thank all the patients and investigators for their participation in this first clinical efficacy trial of ANAVEX庐3-71,鈥� said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. 鈥淭here is a substantial unmet medical need for a drug that can effectively address all symptoms of schizophrenia, and we are hopeful that these results are encouraging for further development of ANAVEX庐3-71 for people with schizophrenia.鈥�
Oral ANAVEX庐3-71 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 without the side effects of standard of care antipsychotics.
The Company expects to report top-line data from the study in the second half of 2025.
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.
About Schizophrenia
Schizophrenia is a persistent and often disabling mental illness impacting how a person thinks, feels, and behaves, and affects nearly 24 million people worldwide, including 2.8 million people in the U.S. It is characterized by three symptom domains: positive symptoms (hallucinations and delusions), negative symptoms (difficulty enjoying life and withdrawal from others), and cognitive impairment (deficits in memory, concentration, and decision-making). In part due to limitations with current treatments, people living with schizophrenia often struggle to maintain employment, live independently, and manage relationships. While current treatments can be effective in managing select symptoms, approximately
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer's disease, Parkinson's disease, schizophrenia, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX庐2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients and one Phase 2/3 study in pediatric patients with Rett syndrome. ANAVEX庐2-73 is an orally available drug candidate designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX庐2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX庐2-73 for the treatment of Parkinson's disease. We believe that ANAVEX庐3-71, which targets SIGMAR1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX庐3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at . You can also connect with the Company on , , , and .
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company鈥檚 most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
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1 Potkin SG, Kane JM, Correll CU, et al. The neurobiology of treatment-resistant schizophrenia: paths to antipsychotic resistance and a roadmap for future research. NPJ Schizophr. 2020;6(1):1. Published 2020 Jan 7. doi:10.1038/s41537-019-0090-z
2 Nucifora FC Jr, Woznica E, Lee BJ, Cascella N, Sawa A. Treatment resistant schizophrenia: Clinical, biological, and therapeutic perspectives. Neurobiol Dis. 2019;131:104257. doi:10.1016/j.nbd.2018.08.016
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